ID

31139

Description

Dose-Escalation Study of TH-302 in Combination With A) Gemcitabine or B) Docetaxel or C) Pemetrexed to Treat Advanced Solid Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT00743379

Lien

https://clinicaltrials.gov/show/NCT00743379

Mots-clés

Versions (1)
  1. 23/07/2018 23/07/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

23 juillet 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00743379

Anglais

Eligibility Non-Small Cell Lung Cancer NCT00743379

1 Formulaires  
Criteria
Description

Criteria

1. at least 18 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. ability to understand the purposes and risks of the study and has signed a written informed consent form
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
3. dose escalation subjects:
Description

Study Subject Dose Escalation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C3816728
a. histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or solid malignancy for which monotherapy with gemcitabine is considered standard therapy b. tumor progression after most recent therapy
Description

Solid Neoplasm metastatic | Solid Neoplasm unresectable | Standard curative treatment Lacking | Standard Palliative Care Lacking | Standard curative treatment ineffective | Standard Palliative Care ineffective | Gemcitabine Standard therapy Solid Neoplasm | Tumor Progression Post Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C0280100
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C1442989
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0332268
UMLS CUI [4,1]
C1442989
UMLS CUI [4,2]
C0030231
UMLS CUI [4,3]
C0332268
UMLS CUI [5,1]
C1442989
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C3242229
UMLS CUI [6,1]
C1442989
UMLS CUI [6,2]
C0030231
UMLS CUI [6,3]
C3242229
UMLS CUI [7,1]
C0045093
UMLS CUI [7,2]
C2936643
UMLS CUI [7,3]
C0280100
UMLS CUI [8,1]
C0178874
UMLS CUI [8,2]
C0687676
UMLS CUI [8,3]
C0087111
dose expansion subjects:
Description

Dose Expansion Cohort

Type de données

boolean

Alias
UMLS CUI [1]
C4521283
a. locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven either by histology (surgical biopsy) or cytology (ct- or endoscopic-guided) previously untreated with chemotherapy other than radiosensitizing doses of 5-fluorouracil
Description

Pancreatic Ductal Adenocarcinoma Unresectable Advanced Locally | Pancreatic Ductal Adenocarcinoma metastatic | Prior Chemotherapy Absent | Exception Fluorouracil Dose Radiosensitization

Type de données

boolean

Alias
UMLS CUI [1,1]
C1335302
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C0205179
UMLS CUI [1,4]
C1517927
UMLS CUI [2,1]
C1335302
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0016360
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0279024
4. recovered from toxicities of prior therapy to grade 0 or 1
Description

Toxicity Due to Prior Therapy | Patient recovered CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1115804
UMLS CUI [2,2]
C1516728
5. evaluable disease by recist criteria (at least one target or non-target lesion)
Description

Evaluable Disease | Target Lesion Quantity | Lesion Quantity

Type de données

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1265611
6. ecog 0 or 1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
7. life expectancy of at least 3 months
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
8. acceptable liver function:
Description

Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
a. bilirubin ≤ 1.5 times upper limit of normal b. ast (sgot) and alt (sgpt) ≤
Description

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
2.5xuln; if liver metastases are present, then ≤ 5xuln is allowed
Description

Relationship Secondary malignant neoplasm of liver

Type de données

boolean

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0494165
9. acceptable renal function:
Description

Renal function

Type de données

boolean

Alias
UMLS CUI [1]
C0232804
a. serum creatinine ≤ uln
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
10. acceptable hematologic status:
Description

Status Hematologic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0205488
1. anc ≥ 1500 cells/μl
Description

Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count ≥ 100,000/μl
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
3. hemoglobin ≥ 9.0 g/dl
Description

Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
11. all women of childbearing potential must have a negative serum pregnancy test and women and men subjects must agree to use effective means of contraception with their partner from entry into the study through 6 months after the last dose
Description

Childbearing Potential Serum pregnancy test negative | Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0700589
docetaxel + th-302 inclusion criteria:
Description

docetaxel plus TH 302 | Inclusion criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C2348906
UMLS CUI [2]
C1512693
all subjects:
Description

Study Subject All

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
1. at least 18 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. ability to understand the purposes and risks of the study and has signed a written informed consent form
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
3. dose escalation subjects only:
Description

Study Subject Dose Escalation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C3816728
a. histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or solid malignancy for which monotherapy with docetaxel would be appropriate b. tumor progression after most recent therapy
Description

Solid Neoplasm metastatic | Solid Neoplasm unresectable | Standard curative treatment Lacking | Standard Palliative Care Lacking | Standard curative treatment ineffective | Standard Palliative Care ineffective | Docetaxel Appropriate Solid Neoplasm | Tumor Progression Post Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C0280100
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C1442989
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0332268
UMLS CUI [4,1]
C1442989
UMLS CUI [4,2]
C0030231
UMLS CUI [4,3]
C0332268
UMLS CUI [5,1]
C1442989
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C3242229
UMLS CUI [6,1]
C1442989
UMLS CUI [6,2]
C0030231
UMLS CUI [6,3]
C3242229
UMLS CUI [7,1]
C0246415
UMLS CUI [7,2]
C1548787
UMLS CUI [7,3]
C0280100
UMLS CUI [8,1]
C0178874
UMLS CUI [8,2]
C0687676
UMLS CUI [8,3]
C0087111
4. recovered from toxicities of prior therapy to grade 0 or 1
Description

Toxicity Due to Prior Therapy | Patient recovered CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1115804
UMLS CUI [2,2]
C1516728
5. evaluable disease by recist criteria (at least one target or non-target lesion) or evidence of disease progression for subjects with metastatic castrate-resistant prostate cancer
Description

Evaluable Disease | Target Lesion Quantity | Lesion Quantity | Disease Progression | Hormone refractory prostate cancer metastatic

Type de données

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0242656
UMLS CUI [5,1]
C1328504
UMLS CUI [5,2]
C1522484
6. ecog 0 or 1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
7. life expectancy of at least 3 months
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
8. acceptable liver function:
Description

Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
a. bilirubin ≤ upper limit of normal b. ast (sgot) and alt (sgpt) ≤ 1.5x uln with alkaline phosphatase ≤ 2.5x uln
Description

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
9. acceptable renal function:
Description

Renal function

Type de données

boolean

Alias
UMLS CUI [1]
C0232804
a. serum creatinine ≤ uln
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
10. acceptable hematologic status:
Description

Status Hematologic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0205488
1. anc ≥ 1500 cells/μl
Description

Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count ≥ 100,000/μl
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
3. hemoglobin ≥ 9.0 g/dl
Description

Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
11. all women of childbearing potential must have a negative serum pregnancy test and women and men subjects must agree to use effective means of contraception with their partner from entry into the study through 6 months after the last dose
Description

Childbearing Potential Serum pregnancy test negative | Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0700589
expanded cohort subjects or dose-escalation subjects with metastatic castrate-resistant prostate cancer previously untreated with chemotherapy:
Description

Dose Expansion Cohort | Study Subject Dose Escalation | Hormone refractory prostate cancer metastatic | Prior Chemotherapy Absent

Type de données

boolean

Alias
UMLS CUI [1]
C4521283
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C3816728
UMLS CUI [3,1]
C1328504
UMLS CUI [3,2]
C1522484
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C0332197
1. histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease
Description

Adenocarcinoma of prostate | Neoplasm Metastasis

Type de données

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C0027627
2. disease progression during hormone therapy and received primary androgenablation therapy as maintenance
Description

Disease Progression During Hormone Therapy | Androgen ablation Primary Maintenance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0279025
UMLS CUI [2,1]
C1515985
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C0024501
3. for subjects who have not had orchiectomy: serum testosterone concentration <50 ng/ml (<1.7 nmol/l); gnrh analog therapy must be continued during this study
Description

Orchiectomy Absent | Serum testosterone measurement | GnRH analog Continue

Type de données

boolean

Alias
UMLS CUI [1,1]
C0029189
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0428413
UMLS CUI [3,1]
C1518041
UMLS CUI [3,2]
C0549178
4. if there has been antiandrogen withdrawal, it must have occurred at least 4 weeks before study enrollment (6 weeks for bicalutamide) or in subjects who have had an antiandrogen added as second-line therapy and there was no response to the most recent antiandrogen therapy or if the psa decline lasted ≤3 months, antiandrogen therapy must be discontinued for at least 2 weeks
Description

Androgen Antagonists Withdrawal | bicalutamide | Androgen Antagonists Second line treatment | Antiandrogen therapy Response Lacking | Prostatic specific antigen decreased | Antiandrogen therapy To be stopped

Type de données

boolean

Alias
UMLS CUI [1,1]
C0002842
UMLS CUI [1,2]
C2349954
UMLS CUI [2]
C0285590
UMLS CUI [3,1]
C0002842
UMLS CUI [3,2]
C1710038
UMLS CUI [4,1]
C0279492
UMLS CUI [4,2]
C1704632
UMLS CUI [4,3]
C0332268
UMLS CUI [5]
C0178414
UMLS CUI [6,1]
C0279492
UMLS CUI [6,2]
C1272691
5. evidence of disease progression, manifested by at least one of the following:
Description

Disease Progression criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0243161
1. rising psa on at least 3 measurements at least 1 week apart
Description

Raised prostate specific antigen Measurement Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1265611
2. disease progression on physical examination or imaging studies (if progression is based on bone scan alone, there must be at least 2 new bone lesions)
Description

Disease Progression Physical Examination | Disease Progression Imaging | Disease Progression Bone scan | Bone lesion New Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0011923
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0203668
UMLS CUI [4,1]
C0238792
UMLS CUI [4,2]
C0205314
UMLS CUI [4,3]
C1265611
6. previously untreated with systemic chemotherapy
Description

Systemic Chemotherapy Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0332197
7. psa at least 2 ng/ml
Description

Prostate specific antigen measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201544
expanded cohort subjects or dose-escalation subjects with second-line nsclc:
Description

Dose Expansion Cohort | Study Subject Dose Escalation | Second line treatment Non-Small Cell Lung Carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C4521283
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C3816728
UMLS CUI [3,1]
C1710038
UMLS CUI [3,2]
C0007131
1. histological or cytological confirmation of nsclc with stage iiib or iv disease not amenable to curative therapy 2. prior treatment with only one systemic chemotherapy regimen for advanced disease 3. tumor progression after most recent therapy
Description

Non-Small Cell Lung Carcinoma | Disease TNM clinical staging Inappropriate Curative treatment | Systemic Chemotherapy Quantity Advanced disease | Tumor Progression Post Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3258246
UMLS CUI [2,3]
C1548788
UMLS CUI [2,4]
C1273390
UMLS CUI [3,1]
C1883256
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0679246
UMLS CUI [4,1]
C0178874
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0087111
pemetrexed + th-302 inclusion criteria:
Description

Pemetrexed plus TH 302 | Inclusion criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0210657
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C2348906
UMLS CUI [2]
C1512693
all subjects:
Description

Study Subject All

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
1. at least 18 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. ability to understand the purposes and risks of the study and has signed a written informed consent form
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
3. dose escalation subjects:
Description

Study Subject Dose Escalation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C3816728
a. histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or solid malignancy for which monotherapy with pemetrexed is considered standard therapy b. tumor progression after most recent therapy
Description

Solid Neoplasm metastatic | Solid Neoplasm unresectable | Standard curative treatment Lacking | Standard Palliative Care Lacking | Standard curative treatment ineffective | Standard Palliative Care ineffective | Pemetrexed Standard therapy Solid Neoplasm | Tumor Progression Post Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C0280100
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C1442989
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0332268
UMLS CUI [4,1]
C1442989
UMLS CUI [4,2]
C0030231
UMLS CUI [4,3]
C0332268
UMLS CUI [5,1]
C1442989
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C3242229
UMLS CUI [6,1]
C1442989
UMLS CUI [6,2]
C0030231
UMLS CUI [6,3]
C3242229
UMLS CUI [7,1]
C0210657
UMLS CUI [7,2]
C2936643
UMLS CUI [7,3]
C0280100
UMLS CUI [8,1]
C0178874
UMLS CUI [8,2]
C0687676
UMLS CUI [8,3]
C0087111
4. recovered from toxicities of prior therapy
Description

Toxicity Due to Prior Therapy | Patient recovered

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2]
C1115804
5. evaluable disease by recist criteria (at least one target or non-target lesion)
Description

Evaluable Disease | Target Lesion Quantity | Lesion Quantity

Type de données

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1265611
6. ecog performance status of 0 or 1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
7. life expectancy of at least 3 months
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
8. acceptable liver function:
Description

Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
1. bilirubin ≤ 1.5x uln
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
2. ast (sgot) and alt (sgpt) ≤ 2.5x uln; if liver metastases are present, then ≤ 5x uln is allowed
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
9. acceptable renal function:
Description

Renal function

Type de données

boolean

Alias
UMLS CUI [1]
C0232804
a. serum creatinine ≤ uln and calculated crcl ≥ 45 ml/min
Description

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
10. acceptable hematologic status:
Description

Status Hematologic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0205488
a. anc ≥ 1500 cells/μl b. platelet count ≥ 100,000/μl c. hemoglobin ≥ 9.0 g/dl
Description

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
11. all women of childbearing potential must have a negative serum pregnancy test and women and men subjects must agree to use effective means of contraception with their partner from entry into the study through 6 months after the last dose expanded cohort subjects only: second-line nsclc
Description

Childbearing Potential Serum pregnancy test negative | Contraceptive methods | Dose Expansion Cohort | Second line treatment Non-Small Cell Lung Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0700589
UMLS CUI [3]
C4521283
UMLS CUI [4,1]
C1710038
UMLS CUI [4,2]
C0007131
1. histological or cytological confirmation of nsclc with stage iiib or iv disease not amenable to curative therapy 2. prior treatment with only one systemic chemotherapy regimen for advanced disease 3. tumor progression after most recent therapy
Description

Non-Small Cell Lung Carcinoma | Disease TNM clinical staging Inappropriate Curative treatment | Systemic Chemotherapy Quantity Advanced disease | Tumor Progression Post Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3258246
UMLS CUI [2,3]
C1548788
UMLS CUI [2,4]
C1273390
UMLS CUI [3,1]
C1883256
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0679246
UMLS CUI [4,1]
C0178874
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0087111
gemcitabine + th-302 exclusion criteria:
Description

Gemcitabine plus TH 302 | Exclusion Criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0045093
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C2348906
UMLS CUI [2]
C0680251
all subjects:
Description

Study Subject All

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
1. prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
Description

Cytotoxic Chemotherapy Myelosuppressive Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C4330729
UMLS CUI [1,3]
C1265611
2. prior treatment with gemcitabine
Description

gemcitabine

Type de données

boolean

Alias
UMLS CUI [1]
C0045093
3. prior radiotherapy to more than 25% of the bone marrow
Description

Prior radiation therapy Bone Marrow Percentage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
4. new york heart association (nyha) class iii or iv, cardiac disease, myocardial infarction within 6 months prior to day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
Description

Heart Disease New York Heart Association Classification | Myocardial Infarction | Cardiac Arrhythmia Unstable | Peripheral Vascular Disease Arterial Symptomatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0085096
UMLS CUI [4,2]
C0221464
UMLS CUI [4,3]
C0231220
5. seizure disorders requiring anticonvulsant therapy
Description

Epilepsy Requirement Anticonvulsant therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0521306
6. symptomatic brain, leptomeningeal or epidural metastases, (unless previously treated and well controlled for a period of ≥ 3 months)
Description

Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic | Epidural space Neoplasm Metastasis Symptomatic | Exception Neoplasm Metastasis Well controlled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1704231
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0014537
UMLS CUI [3,2]
C0027627
UMLS CUI [3,3]
C0231220
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0027627
UMLS CUI [4,3]
C3853142
7. previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
Description

Prior Therapy Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated | Exception Cancer Other Disease Free of

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1707251
UMLS CUI [4,3]
C0012634
UMLS CUI [4,4]
C0332296
8. severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia
Description

Severe chronic obstructive pulmonary disease | Severe chronic lung disease | Hypoxemia | Requirement Oxygen supplementation | Symptoms Due to Hypoxemia | Oxygen saturation measurement Pulse Oximetry | Status post 2-Minute Walk Endurance Test | Physiological state Causing Hypoxemia Systemic | Physiological state Causing Hypoxemia regional

Type de données

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C3278799
UMLS CUI [3]
C0700292
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0919655
UMLS CUI [5,1]
C1457887
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0700292
UMLS CUI [6,1]
C0523807
UMLS CUI [6,2]
C0034108
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C4284677
UMLS CUI [8,1]
C4062486
UMLS CUI [8,2]
C0678227
UMLS CUI [8,3]
C0700292
UMLS CUI [8,4]
C0205373
UMLS CUI [9,1]
C4062486
UMLS CUI [9,2]
C0678227
UMLS CUI [9,3]
C0700292
UMLS CUI [9,4]
C0205147
9. major surgery, other than diagnostic surgery, within 4 weeks prior to day 1, without complete recovery
Description

Major surgery | Exception Diagnostic surgical procedure | Complete Recovery Lacking

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0522769
UMLS CUI [3,1]
C2826210
UMLS CUI [3,2]
C0332268
10. active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Description

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Requirement Systemic therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C1515119
11. treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 4 weeks prior to study entry
Description

Therapeutic radiology procedure | Operative Surgical Procedures | Chemotherapy | Targeted Therapy | Hormone Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C2985566
UMLS CUI [5]
C0279025
12. prior therapy with an hypoxic cytotoxin
Description

Cytotoxin Hypoxic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0010868
UMLS CUI [1,2]
C0242184
13. subjects who participated in an investigational drug or device study within 28 days prior to study entry
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
14. known infection with hiv, hepatitis b or c
Description

HIV Infection | Hepatitis B | Hepatitis C

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
15. subjects who have exhibited allergic reactions to a structural compound, biological agent, or formulation (containing solutol and/or propylene glycol) similar to th-302
Description

Allergic Reaction Compound TH 302 Similar | Allergic Reaction Biological agent TH 302 Similar | Allergic Reaction Drug Formulation TH 302 Similar | Allergic Reaction Drug Formulation Containing Solutol HS 15 | Allergic Reaction Drug Formulation Containing Propylene glycol

Type de données

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C2348906
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0005515
UMLS CUI [2,3]
C2348906
UMLS CUI [2,4]
C2348205
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0524527
UMLS CUI [3,3]
C2348906
UMLS CUI [3,4]
C2348205
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0524527
UMLS CUI [4,3]
C0332256
UMLS CUI [4,4]
C0084586
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0524527
UMLS CUI [5,3]
C0332256
UMLS CUI [5,4]
C0072225
16. females who are pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
17. concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Description

Comorbidity Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Comorbidity Study Subject Participation Status At risk | Condition Study Subject Participation Status At risk

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
18. unwillingness or inability to comply with the study protocol for any reason expanded cohort subjects only: first-line advanced adenocarcinoma of the pancreas
Description

Protocol Compliance Unwilling | Protocol Compliance Unable | Dose Expansion Cohort | First line treatment Adenocarcinoma of pancreas Advanced

Type de données

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
UMLS CUI [3]
C4521283
UMLS CUI [4,1]
C1708063
UMLS CUI [4,2]
C0281361
UMLS CUI [4,3]
C0205179
1. prior chemotherapy therapy for advanced disease other than radiosensitizing doses of 5-fluorouracil
Description

Prior Chemotherapy Advanced disease | Exception Fluorouracil Dose Radiosensitization

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0679246
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0016360
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0279024
docetaxel + prednisone + th-302 exclusion criteria:
Description

Docetaxel plus Prednisone plus TH 302 | Exclusion Criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0032952
UMLS CUI [1,4]
C0332287
UMLS CUI [1,5]
C2348906
UMLS CUI [2]
C0680251
all subjects:
Description

Study Subject All

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
1. prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
Description

Cytotoxic Chemotherapy Myelosuppressive Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C4330729
UMLS CUI [1,3]
C1265611
2. prior treatment with docetaxel
Description

docetaxel

Type de données

boolean

Alias
UMLS CUI [1]
C0246415
3. prior radiotherapy to more than 25% of the bone marrow unless radiotherapy was completed >5 years ago and there is not hematologic evidence of persistent bone marrow suppression
Description

Prior radiation therapy Bone Marrow Percentage | Exception Therapeutic radiology procedure Completed | Exception Absence Bone Marrow Suppression Persistent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0205197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0280962
UMLS CUI [3,4]
C0205322
4. uncontrolled pleural effusion or ascites
Description

Pleural effusion Uncontrolled | Ascites Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0205318
5. history of sensitivity to drugs formulated with polysorbate 80
Description

Hypersensitivity Polysorbate 80 Formulation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0032601
UMLS CUI [1,3]
C0524527
6. new york heart association (nyha) class iii or iv, cardiac disease, myocardial infarction within 6 months prior to day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
Description

Heart Disease New York Heart Association Classification | Myocardial Infarction | Cardiac Arrhythmia Unstable | Peripheral Vascular Disease Arterial Symptomatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0085096
UMLS CUI [4,2]
C0221464
UMLS CUI [4,3]
C0231220
7. seizure disorders requiring anticonvulsant therapy
Description

Epilepsy Requirement Anticonvulsant therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0521306
8. symptomatic brain, leptomeningeal or epidural metastases (unless previously treated and well controlled for a period of ≥ 3 months)
Description

Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic | Epidural space Neoplasm Metastasis Symptomatic | Exception Neoplasm Metastasis Well controlled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1704231
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0014537
UMLS CUI [3,2]
C0027627
UMLS CUI [3,3]
C0231220
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0027627
UMLS CUI [4,3]
C3853142
9. ongoing ctcae grade 2 or greater peripheral neuropathy
Description

Peripheral Neuropathy CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
10. previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
Description

Prior Therapy Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated | Exception Cancer Other Disease Free of

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1707251
UMLS CUI [4,3]
C0012634
UMLS CUI [4,4]
C0332296
11. severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia
Description

Severe chronic obstructive pulmonary disease | Severe chronic lung disease | Hypoxemia | Requirement Oxygen supplementation | Symptoms Due to Hypoxemia | Oxygen saturation measurement Pulse Oximetry | Status post 2-Minute Walk Endurance Test | Physiological state Causing Hypoxemia Systemic | Physiological state Causing Hypoxemia regional

Type de données

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C3278799
UMLS CUI [3]
C0700292
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0919655
UMLS CUI [5,1]
C1457887
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0700292
UMLS CUI [6,1]
C0523807
UMLS CUI [6,2]
C0034108
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C4284677
UMLS CUI [8,1]
C4062486
UMLS CUI [8,2]
C0678227
UMLS CUI [8,3]
C0700292
UMLS CUI [8,4]
C0205373
UMLS CUI [9,1]
C4062486
UMLS CUI [9,2]
C0678227
UMLS CUI [9,3]
C0700292
UMLS CUI [9,4]
C0205147
12. major surgery, other than diagnostic surgery, within 4 weeks prior to day 1, without complete recovery
Description

Major surgery | Exception Diagnostic surgical procedure | Complete Recovery Lacking

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0522769
UMLS CUI [3,1]
C2826210
UMLS CUI [3,2]
C0332268
13. active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Description

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Requirement Systemic therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C1515119
14. treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 4 weeks prior to study entry
Description

Therapeutic radiology procedure | Operative Surgical Procedures | Chemotherapy | Targeted Therapy | Hormone Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C2985566
UMLS CUI [5]
C0279025
15. prior therapy with an hypoxic cytotoxin
Description

Cytotoxin Hypoxic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0010868
UMLS CUI [1,2]
C0242184
16. subjects who participated in an investigational drug or device study within 28 days prior to study entry
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
17. known active infection with hiv, hepatitis b or c
Description

HIV Infection | Hepatitis B | Hepatitis C

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
18. subjects who have exhibited allergic reactions to a structural compound, biological agent, or formulation (containing solutol and/or propylene glycol) similar to th-302
Description

Allergic Reaction Compound TH 302 Similar | Allergic Reaction Biological agent TH 302 Similar | Allergic Reaction Drug Formulation TH 302 Similar | Allergic Reaction Drug Formulation Containing Solutol HS 15 | Allergic Reaction Drug Formulation Containing Propylene glycol

Type de données

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C2348906
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0005515
UMLS CUI [2,3]
C2348906
UMLS CUI [2,4]
C2348205
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0524527
UMLS CUI [3,3]
C2348906
UMLS CUI [3,4]
C2348205
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0524527
UMLS CUI [4,3]
C0332256
UMLS CUI [4,4]
C0084586
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0524527
UMLS CUI [5,3]
C0332256
UMLS CUI [5,4]
C0072225
19. females who are pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
20. concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Description

Comorbidity Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Comorbidity Study Subject Participation Status At risk | Condition Study Subject Participation Status At risk

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
21. unwillingness or inability to comply with the study protocol for any reason expanded cohort subjects only: castrate-resistant prostate cancer
Description

Protocol Compliance Unwilling | Protocol Compliance Unable | Dose Expansion Cohort | Hormone refractory prostate cancer

Type de données

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
UMLS CUI [3]
C4521283
UMLS CUI [4]
C1328504
1. prior treatment with cytotoxic chemotherapy or radioisotope therapy expanded cohort subjects only: second-line nsclc
Description

Cytotoxic Chemotherapy | Radionuclide therapy | Dose Expansion Cohort | Second line treatment Non-Small Cell Lung Carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0203608
UMLS CUI [3]
C4521283
UMLS CUI [4,1]
C1710038
UMLS CUI [4,2]
C0007131
1. more than one prior cytotoxic chemotherapy regimen for advanced disease
Description

Cytotoxic Chemotherapy Quantity Advanced disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
2. weight loss of >10% body weight in the previous 6 weeks
Description

Weight decreased Percentage

Type de données

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
pemetrexed + th-302 exclusion criteria:
Description

Pemetrexed plus TH 302 | Exclusion Criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0210657
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C2348906
UMLS CUI [2]
C0680251
all subjects:
Description

Study Subject All

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
1. prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
Description

Cytotoxic Chemotherapy Myelosuppressive Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C4330729
UMLS CUI [1,3]
C1265611
2. prior treatment with pemetrexed
Description

pemetrexed

Type de données

boolean

Alias
UMLS CUI [1]
C0210657
3. prior radiotherapy to more than 25% of the bone marrow
Description

Prior radiation therapy Bone Marrow Percentage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
4. inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or 2 days (short half-life, if subject has crcl <80 ml/min) before until 2 days following pemetrexed dosing
Description

Unable to discontinue Non-Steroidal Anti-Inflammatory Agents | Creatinine clearance measurement | Status post Pemetrexed Dose

Type de données

boolean

Alias
UMLS CUI [1,1]
C1548265
UMLS CUI [1,2]
C0003211
UMLS CUI [2]
C0373595
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0210657
UMLS CUI [3,3]
C0178602
5. new york heart association (nyha) class iii or iv, cardiac disease, myocardial infarction within 6 months prior to day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
Description

Heart Disease New York Heart Association Classification | Myocardial Infarction | Cardiac Arrhythmia Unstable | Peripheral Vascular Disease Arterial Symptomatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0085096
UMLS CUI [4,2]
C0221464
UMLS CUI [4,3]
C0231220
6. seizure disorders requiring anticonvulsant therapy
Description

Epilepsy Requirement Anticonvulsant therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0521306
7. symptomatic brain, leptomeningeal or epidural metastases (unless previously treated and well controlled for a period of ≥ 3 months)
Description

Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic | Epidural space Neoplasm Metastasis Symptomatic | Exception Neoplasm Metastasis Well controlled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1704231
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0014537
UMLS CUI [3,2]
C0027627
UMLS CUI [3,3]
C0231220
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0027627
UMLS CUI [4,3]
C3853142
8. previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
Description

Prior Therapy Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated | Exception Cancer Other Disease Free of

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1707251
UMLS CUI [4,3]
C0012634
UMLS CUI [4,4]
C0332296
9. severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia
Description

Severe chronic obstructive pulmonary disease | Severe chronic lung disease | Hypoxemia | Requirement Oxygen supplementation | Symptoms Due to Hypoxemia | Oxygen saturation measurement Pulse Oximetry | Status post 2-Minute Walk Endurance Test | Physiological state Causing Hypoxemia Systemic | Physiological state Causing Hypoxemia regional

Type de données

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C3278799
UMLS CUI [3]
C0700292
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0919655
UMLS CUI [5,1]
C1457887
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0700292
UMLS CUI [6,1]
C0523807
UMLS CUI [6,2]
C0034108
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C4284677
UMLS CUI [8,1]
C4062486
UMLS CUI [8,2]
C0678227
UMLS CUI [8,3]
C0700292
UMLS CUI [8,4]
C0205373
UMLS CUI [9,1]
C4062486
UMLS CUI [9,2]
C0678227
UMLS CUI [9,3]
C0700292
UMLS CUI [9,4]
C0205147
10. major surgery, other than diagnostic surgery, within 4 weeks prior to day 1, without complete recovery
Description

Major surgery | Exception Diagnostic surgical procedure | Complete Recovery Lacking

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0522769
UMLS CUI [3,1]
C2826210
UMLS CUI [3,2]
C0332268
11. active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Description

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Requirement Systemic therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C1515119
12. treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 4 weeks prior to study entry
Description

Therapeutic radiology procedure | Operative Surgical Procedures | Chemotherapy | Targeted Therapy | Hormone Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C2985566
UMLS CUI [5]
C0279025
13. prior therapy with an hypoxic cytotoxin
Description

Cytotoxin Hypoxic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0010868
UMLS CUI [1,2]
C0242184
14. subjects who participated in an investigational drug or device study within 28 days prior to study entry
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
15. known active infection with hiv, hepatitis b, or hepatitis c
Description

HIV Infection | Hepatitis B | Hepatitis C

Type de données

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
16. subjects who have exhibited allergic reactions to a structural compound, biological agent, or formulation (containing solutol and/or propylene glycol) similar to th-302
Description

Allergic Reaction Compound TH 302 Similar | Allergic Reaction Biological agent TH 302 Similar | Allergic Reaction Drug Formulation TH 302 Similar | Allergic Reaction Drug Formulation Containing Solutol HS 15 | Allergic Reaction Drug Formulation Containing Propylene glycol

Type de données

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C2348906
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0005515
UMLS CUI [2,3]
C2348906
UMLS CUI [2,4]
C2348205
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0524527
UMLS CUI [3,3]
C2348906
UMLS CUI [3,4]
C2348205
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0524527
UMLS CUI [4,3]
C0332256
UMLS CUI [4,4]
C0084586
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0524527
UMLS CUI [5,3]
C0332256
UMLS CUI [5,4]
C0072225
17. females who are pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
18. concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Description

Comorbidity Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Comorbidity Study Subject Participation Status At risk | Condition Study Subject Participation Status At risk

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
19. unwillingness or inability to comply with the study protocol for any reason expanded cohort subjects only: second-line nsclc
Description

Protocol Compliance Unwilling | Protocol Compliance Unable | Dose Expansion Cohort | Second line treatment Non-Small Cell Lung Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
UMLS CUI [3]
C4521283
UMLS CUI [4,1]
C1710038
UMLS CUI [4,2]
C0007131
1. more than one prior cytotoxic chemotherapy regimen for advanced disease 2. weight loss of >10% body weight in the previous 6 weeks
Description

Cytotoxic Chemotherapy Quantity Advanced disease | Weight decreased Percentage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0439165
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00743379

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Age
Item
1. at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. ability to understand the purposes and risks of the study and has signed a written informed consent form
boolean
C0021430 (UMLS CUI [1])
Study Subject Dose Escalation
Item
3. dose escalation subjects:
boolean
C0681850 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
Solid Neoplasm metastatic | Solid Neoplasm unresectable | Standard curative treatment Lacking | Standard Palliative Care Lacking | Standard curative treatment ineffective | Standard Palliative Care ineffective | Gemcitabine Standard therapy Solid Neoplasm | Tumor Progression Post Therapeutic procedure
Item
a. histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or solid malignancy for which monotherapy with gemcitabine is considered standard therapy b. tumor progression after most recent therapy
boolean
C0280100 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0280100 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1442989 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C1442989 (UMLS CUI [4,1])
C0030231 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
C1442989 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C3242229 (UMLS CUI [5,3])
C1442989 (UMLS CUI [6,1])
C0030231 (UMLS CUI [6,2])
C3242229 (UMLS CUI [6,3])
C0045093 (UMLS CUI [7,1])
C2936643 (UMLS CUI [7,2])
C0280100 (UMLS CUI [7,3])
C0178874 (UMLS CUI [8,1])
C0687676 (UMLS CUI [8,2])
C0087111 (UMLS CUI [8,3])
Dose Expansion Cohort
Item
dose expansion subjects:
boolean
C4521283 (UMLS CUI [1])
Pancreatic Ductal Adenocarcinoma Unresectable Advanced Locally | Pancreatic Ductal Adenocarcinoma metastatic | Prior Chemotherapy Absent | Exception Fluorouracil Dose Radiosensitization
Item
a. locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven either by histology (surgical biopsy) or cytology (ct- or endoscopic-guided) previously untreated with chemotherapy other than radiosensitizing doses of 5-fluorouracil
boolean
C1335302 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1517927 (UMLS CUI [1,4])
C1335302 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0016360 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0279024 (UMLS CUI [4,4])
Toxicity Due to Prior Therapy | Patient recovered CTCAE Grades
Item
4. recovered from toxicities of prior therapy to grade 0 or 1
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Evaluable Disease | Target Lesion Quantity | Lesion Quantity
Item
5. evaluable disease by recist criteria (at least one target or non-target lesion)
boolean
C1516986 (UMLS CUI [1])
C2986546 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
ECOG performance status
Item
6. ecog 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Liver function
Item
8. acceptable liver function:
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
a. bilirubin ≤ 1.5 times upper limit of normal b. ast (sgot) and alt (sgpt) ≤
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Relationship Secondary malignant neoplasm of liver
Item
2.5xuln; if liver metastases are present, then ≤ 5xuln is allowed
boolean
C0439849 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
Renal function
Item
9. acceptable renal function:
boolean
C0232804 (UMLS CUI [1])
Creatinine measurement, serum
Item
a. serum creatinine ≤ uln
boolean
C0201976 (UMLS CUI [1])
Status Hematologic
Item
10. acceptable hematologic status:
boolean
C0449438 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
Absolute neutrophil count
Item
1. anc ≥ 1500 cells/μl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count ≥ 100,000/μl
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
3. hemoglobin ≥ 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Contraceptive methods
Item
11. all women of childbearing potential must have a negative serum pregnancy test and women and men subjects must agree to use effective means of contraception with their partner from entry into the study through 6 months after the last dose
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
docetaxel plus TH 302 | Inclusion criteria
Item
docetaxel + th-302 inclusion criteria:
boolean
C0246415 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C2348906 (UMLS CUI [1,3])
C1512693 (UMLS CUI [2])
Study Subject All
Item
all subjects:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Age
Item
1. at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. ability to understand the purposes and risks of the study and has signed a written informed consent form
boolean
C0021430 (UMLS CUI [1])
Study Subject Dose Escalation
Item
3. dose escalation subjects only:
boolean
C0681850 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
Solid Neoplasm metastatic | Solid Neoplasm unresectable | Standard curative treatment Lacking | Standard Palliative Care Lacking | Standard curative treatment ineffective | Standard Palliative Care ineffective | Docetaxel Appropriate Solid Neoplasm | Tumor Progression Post Therapeutic procedure
Item
a. histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or solid malignancy for which monotherapy with docetaxel would be appropriate b. tumor progression after most recent therapy
boolean
C0280100 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0280100 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1442989 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C1442989 (UMLS CUI [4,1])
C0030231 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
C1442989 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C3242229 (UMLS CUI [5,3])
C1442989 (UMLS CUI [6,1])
C0030231 (UMLS CUI [6,2])
C3242229 (UMLS CUI [6,3])
C0246415 (UMLS CUI [7,1])
C1548787 (UMLS CUI [7,2])
C0280100 (UMLS CUI [7,3])
C0178874 (UMLS CUI [8,1])
C0687676 (UMLS CUI [8,2])
C0087111 (UMLS CUI [8,3])
Toxicity Due to Prior Therapy | Patient recovered CTCAE Grades
Item
4. recovered from toxicities of prior therapy to grade 0 or 1
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Evaluable Disease | Target Lesion Quantity | Lesion Quantity | Disease Progression | Hormone refractory prostate cancer metastatic
Item
5. evaluable disease by recist criteria (at least one target or non-target lesion) or evidence of disease progression for subjects with metastatic castrate-resistant prostate cancer
boolean
C1516986 (UMLS CUI [1])
C2986546 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
C1328504 (UMLS CUI [5,1])
C1522484 (UMLS CUI [5,2])
ECOG performance status
Item
6. ecog 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Liver function
Item
8. acceptable liver function:
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
a. bilirubin ≤ upper limit of normal b. ast (sgot) and alt (sgpt) ≤ 1.5x uln with alkaline phosphatase ≤ 2.5x uln
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
Renal function
Item
9. acceptable renal function:
boolean
C0232804 (UMLS CUI [1])
Creatinine measurement, serum
Item
a. serum creatinine ≤ uln
boolean
C0201976 (UMLS CUI [1])
Status Hematologic
Item
10. acceptable hematologic status:
boolean
C0449438 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
Absolute neutrophil count
Item
1. anc ≥ 1500 cells/μl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count ≥ 100,000/μl
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
3. hemoglobin ≥ 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Contraceptive methods
Item
11. all women of childbearing potential must have a negative serum pregnancy test and women and men subjects must agree to use effective means of contraception with their partner from entry into the study through 6 months after the last dose
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
Dose Expansion Cohort | Study Subject Dose Escalation | Hormone refractory prostate cancer metastatic | Prior Chemotherapy Absent
Item
expanded cohort subjects or dose-escalation subjects with metastatic castrate-resistant prostate cancer previously untreated with chemotherapy:
boolean
C4521283 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C3816728 (UMLS CUI [2,2])
C1328504 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
C1514457 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Adenocarcinoma of prostate | Neoplasm Metastasis
Item
1. histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease
boolean
C0007112 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Disease Progression During Hormone Therapy | Androgen ablation Primary Maintenance
Item
2. disease progression during hormone therapy and received primary androgenablation therapy as maintenance
boolean
C0242656 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0279025 (UMLS CUI [1,3])
C1515985 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0024501 (UMLS CUI [2,3])
Orchiectomy Absent | Serum testosterone measurement | GnRH analog Continue
Item
3. for subjects who have not had orchiectomy: serum testosterone concentration <50 ng/ml (<1.7 nmol/l); gnrh analog therapy must be continued during this study
boolean
C0029189 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0428413 (UMLS CUI [2])
C1518041 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
Androgen Antagonists Withdrawal | bicalutamide | Androgen Antagonists Second line treatment | Antiandrogen therapy Response Lacking | Prostatic specific antigen decreased | Antiandrogen therapy To be stopped
Item
4. if there has been antiandrogen withdrawal, it must have occurred at least 4 weeks before study enrollment (6 weeks for bicalutamide) or in subjects who have had an antiandrogen added as second-line therapy and there was no response to the most recent antiandrogen therapy or if the psa decline lasted ≤3 months, antiandrogen therapy must be discontinued for at least 2 weeks
boolean
C0002842 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0285590 (UMLS CUI [2])
C0002842 (UMLS CUI [3,1])
C1710038 (UMLS CUI [3,2])
C0279492 (UMLS CUI [4,1])
C1704632 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
C0178414 (UMLS CUI [5])
C0279492 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
Disease Progression criteria
Item
5. evidence of disease progression, manifested by at least one of the following:
boolean
C0242656 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Raised prostate specific antigen Measurement Quantity
Item
1. rising psa on at least 3 measurements at least 1 week apart
boolean
C0178415 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Disease Progression Physical Examination | Disease Progression Imaging | Disease Progression Bone scan | Bone lesion New Quantity
Item
2. disease progression on physical examination or imaging studies (if progression is based on bone scan alone, there must be at least 2 new bone lesions)
boolean
C0242656 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3,1])
C0203668 (UMLS CUI [3,2])
C0238792 (UMLS CUI [4,1])
C0205314 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Systemic Chemotherapy Absent
Item
6. previously untreated with systemic chemotherapy
boolean
C1883256 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Prostate specific antigen measurement
Item
7. psa at least 2 ng/ml
boolean
C0201544 (UMLS CUI [1])
Dose Expansion Cohort | Study Subject Dose Escalation | Second line treatment Non-Small Cell Lung Carcinoma
Item
expanded cohort subjects or dose-escalation subjects with second-line nsclc:
boolean
C4521283 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C3816728 (UMLS CUI [2,2])
C1710038 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
Non-Small Cell Lung Carcinoma | Disease TNM clinical staging Inappropriate Curative treatment | Systemic Chemotherapy Quantity Advanced disease | Tumor Progression Post Therapeutic procedure
Item
1. histological or cytological confirmation of nsclc with stage iiib or iv disease not amenable to curative therapy 2. prior treatment with only one systemic chemotherapy regimen for advanced disease 3. tumor progression after most recent therapy
boolean
C0007131 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C1273390 (UMLS CUI [2,4])
C1883256 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0679246 (UMLS CUI [3,3])
C0178874 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
Pemetrexed plus TH 302 | Inclusion criteria
Item
pemetrexed + th-302 inclusion criteria:
boolean
C0210657 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C2348906 (UMLS CUI [1,3])
C1512693 (UMLS CUI [2])
Study Subject All
Item
all subjects:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Age
Item
1. at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. ability to understand the purposes and risks of the study and has signed a written informed consent form
boolean
C0021430 (UMLS CUI [1])
Study Subject Dose Escalation
Item
3. dose escalation subjects:
boolean
C0681850 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
Solid Neoplasm metastatic | Solid Neoplasm unresectable | Standard curative treatment Lacking | Standard Palliative Care Lacking | Standard curative treatment ineffective | Standard Palliative Care ineffective | Pemetrexed Standard therapy Solid Neoplasm | Tumor Progression Post Therapeutic procedure
Item
a. histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or solid malignancy for which monotherapy with pemetrexed is considered standard therapy b. tumor progression after most recent therapy
boolean
C0280100 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0280100 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C1442989 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C1442989 (UMLS CUI [4,1])
C0030231 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
C1442989 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C3242229 (UMLS CUI [5,3])
C1442989 (UMLS CUI [6,1])
C0030231 (UMLS CUI [6,2])
C3242229 (UMLS CUI [6,3])
C0210657 (UMLS CUI [7,1])
C2936643 (UMLS CUI [7,2])
C0280100 (UMLS CUI [7,3])
C0178874 (UMLS CUI [8,1])
C0687676 (UMLS CUI [8,2])
C0087111 (UMLS CUI [8,3])
Toxicity Due to Prior Therapy | Patient recovered
Item
4. recovered from toxicities of prior therapy
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
Evaluable Disease | Target Lesion Quantity | Lesion Quantity
Item
5. evaluable disease by recist criteria (at least one target or non-target lesion)
boolean
C1516986 (UMLS CUI [1])
C2986546 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
ECOG performance status
Item
6. ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Liver function
Item
8. acceptable liver function:
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement
Item
1. bilirubin ≤ 1.5x uln
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
2. ast (sgot) and alt (sgpt) ≤ 2.5x uln; if liver metastases are present, then ≤ 5x uln is allowed
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Renal function
Item
9. acceptable renal function:
boolean
C0232804 (UMLS CUI [1])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
a. serum creatinine ≤ uln and calculated crcl ≥ 45 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Status Hematologic
Item
10. acceptable hematologic status:
boolean
C0449438 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
a. anc ≥ 1500 cells/μl b. platelet count ≥ 100,000/μl c. hemoglobin ≥ 9.0 g/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Childbearing Potential Serum pregnancy test negative | Contraceptive methods | Dose Expansion Cohort | Second line treatment Non-Small Cell Lung Carcinoma
Item
11. all women of childbearing potential must have a negative serum pregnancy test and women and men subjects must agree to use effective means of contraception with their partner from entry into the study through 6 months after the last dose expanded cohort subjects only: second-line nsclc
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
C4521283 (UMLS CUI [3])
C1710038 (UMLS CUI [4,1])
C0007131 (UMLS CUI [4,2])
Non-Small Cell Lung Carcinoma | Disease TNM clinical staging Inappropriate Curative treatment | Systemic Chemotherapy Quantity Advanced disease | Tumor Progression Post Therapeutic procedure
Item
1. histological or cytological confirmation of nsclc with stage iiib or iv disease not amenable to curative therapy 2. prior treatment with only one systemic chemotherapy regimen for advanced disease 3. tumor progression after most recent therapy
boolean
C0007131 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C1273390 (UMLS CUI [2,4])
C1883256 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0679246 (UMLS CUI [3,3])
C0178874 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
Gemcitabine plus TH 302 | Exclusion Criteria
Item
gemcitabine + th-302 exclusion criteria:
boolean
C0045093 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C2348906 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2])
Study Subject All
Item
all subjects:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Cytotoxic Chemotherapy Myelosuppressive Quantity
Item
1. prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
boolean
C0677881 (UMLS CUI [1,1])
C4330729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
gemcitabine
Item
2. prior treatment with gemcitabine
boolean
C0045093 (UMLS CUI [1])
Prior radiation therapy Bone Marrow Percentage
Item
3. prior radiotherapy to more than 25% of the bone marrow
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Heart Disease New York Heart Association Classification | Myocardial Infarction | Cardiac Arrhythmia Unstable | Peripheral Vascular Disease Arterial Symptomatic
Item
4. new york heart association (nyha) class iii or iv, cardiac disease, myocardial infarction within 6 months prior to day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0085096 (UMLS CUI [4,1])
C0221464 (UMLS CUI [4,2])
C0231220 (UMLS CUI [4,3])
Epilepsy Requirement Anticonvulsant therapy
Item
5. seizure disorders requiring anticonvulsant therapy
boolean
C0014544 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0521306 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic | Epidural space Neoplasm Metastasis Symptomatic | Exception Neoplasm Metastasis Well controlled
Item
6. symptomatic brain, leptomeningeal or epidural metastases, (unless previously treated and well controlled for a period of ≥ 3 months)
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0014537 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0231220 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C3853142 (UMLS CUI [4,3])
Prior Therapy Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated | Exception Cancer Other Disease Free of
Item
7. previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
boolean
C1514463 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1707251 (UMLS CUI [4,2])
C0012634 (UMLS CUI [4,3])
C0332296 (UMLS CUI [4,4])
Severe chronic obstructive pulmonary disease | Severe chronic lung disease | Hypoxemia | Requirement Oxygen supplementation | Symptoms Due to Hypoxemia | Oxygen saturation measurement Pulse Oximetry | Status post 2-Minute Walk Endurance Test | Physiological state Causing Hypoxemia Systemic | Physiological state Causing Hypoxemia regional
Item
8. severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia
boolean
C0730607 (UMLS CUI [1])
C3278799 (UMLS CUI [2])
C0700292 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0919655 (UMLS CUI [4,2])
C1457887 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0700292 (UMLS CUI [5,3])
C0523807 (UMLS CUI [6,1])
C0034108 (UMLS CUI [6,2])
C0231290 (UMLS CUI [7,1])
C4284677 (UMLS CUI [7,2])
C4062486 (UMLS CUI [8,1])
C0678227 (UMLS CUI [8,2])
C0700292 (UMLS CUI [8,3])
C0205373 (UMLS CUI [8,4])
C4062486 (UMLS CUI [9,1])
C0678227 (UMLS CUI [9,2])
C0700292 (UMLS CUI [9,3])
C0205147 (UMLS CUI [9,4])
Major surgery | Exception Diagnostic surgical procedure | Complete Recovery Lacking
Item
9. major surgery, other than diagnostic surgery, within 4 weeks prior to day 1, without complete recovery
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0522769 (UMLS CUI [2,2])
C2826210 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Requirement Systemic therapy
Item
10. active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
Therapeutic radiology procedure | Operative Surgical Procedures | Chemotherapy | Targeted Therapy | Hormone Therapy
Item
11. treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 4 weeks prior to study entry
boolean
C1522449 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C2985566 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
Cytotoxin Hypoxic
Item
12. prior therapy with an hypoxic cytotoxin
boolean
C0010868 (UMLS CUI [1,1])
C0242184 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
13. subjects who participated in an investigational drug or device study within 28 days prior to study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
HIV Infection | Hepatitis B | Hepatitis C
Item
14. known infection with hiv, hepatitis b or c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Allergic Reaction Compound TH 302 Similar | Allergic Reaction Biological agent TH 302 Similar | Allergic Reaction Drug Formulation TH 302 Similar | Allergic Reaction Drug Formulation Containing Solutol HS 15 | Allergic Reaction Drug Formulation Containing Propylene glycol
Item
15. subjects who have exhibited allergic reactions to a structural compound, biological agent, or formulation (containing solutol and/or propylene glycol) similar to th-302
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C2348906 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0005515 (UMLS CUI [2,2])
C2348906 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C0524527 (UMLS CUI [3,2])
C2348906 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
C1527304 (UMLS CUI [4,1])
C0524527 (UMLS CUI [4,2])
C0332256 (UMLS CUI [4,3])
C0084586 (UMLS CUI [4,4])
C1527304 (UMLS CUI [5,1])
C0524527 (UMLS CUI [5,2])
C0332256 (UMLS CUI [5,3])
C0072225 (UMLS CUI [5,4])
Pregnancy | Breast Feeding
Item
16. females who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Comorbidity Study Subject Participation Status At risk | Condition Study Subject Participation Status At risk
Item
17. concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
Protocol Compliance Unwilling | Protocol Compliance Unable | Dose Expansion Cohort | First line treatment Adenocarcinoma of pancreas Advanced
Item
18. unwillingness or inability to comply with the study protocol for any reason expanded cohort subjects only: first-line advanced adenocarcinoma of the pancreas
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C4521283 (UMLS CUI [3])
C1708063 (UMLS CUI [4,1])
C0281361 (UMLS CUI [4,2])
C0205179 (UMLS CUI [4,3])
Prior Chemotherapy Advanced disease | Exception Fluorouracil Dose Radiosensitization
Item
1. prior chemotherapy therapy for advanced disease other than radiosensitizing doses of 5-fluorouracil
boolean
C1514457 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0016360 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0279024 (UMLS CUI [2,4])
Docetaxel plus Prednisone plus TH 302 | Exclusion Criteria
Item
docetaxel + prednisone + th-302 exclusion criteria:
boolean
C0246415 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
C0332287 (UMLS CUI [1,4])
C2348906 (UMLS CUI [1,5])
C0680251 (UMLS CUI [2])
Study Subject All
Item
all subjects:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Cytotoxic Chemotherapy Myelosuppressive Quantity
Item
1. prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
boolean
C0677881 (UMLS CUI [1,1])
C4330729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
docetaxel
Item
2. prior treatment with docetaxel
boolean
C0246415 (UMLS CUI [1])
Prior radiation therapy Bone Marrow Percentage | Exception Therapeutic radiology procedure Completed | Exception Absence Bone Marrow Suppression Persistent
Item
3. prior radiotherapy to more than 25% of the bone marrow unless radiotherapy was completed >5 years ago and there is not hematologic evidence of persistent bone marrow suppression
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0280962 (UMLS CUI [3,3])
C0205322 (UMLS CUI [3,4])
Pleural effusion Uncontrolled | Ascites Uncontrolled
Item
4. uncontrolled pleural effusion or ascites
boolean
C0032227 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Hypersensitivity Polysorbate 80 Formulation
Item
5. history of sensitivity to drugs formulated with polysorbate 80
boolean
C0020517 (UMLS CUI [1,1])
C0032601 (UMLS CUI [1,2])
C0524527 (UMLS CUI [1,3])
Heart Disease New York Heart Association Classification | Myocardial Infarction | Cardiac Arrhythmia Unstable | Peripheral Vascular Disease Arterial Symptomatic
Item
6. new york heart association (nyha) class iii or iv, cardiac disease, myocardial infarction within 6 months prior to day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0085096 (UMLS CUI [4,1])
C0221464 (UMLS CUI [4,2])
C0231220 (UMLS CUI [4,3])
Epilepsy Requirement Anticonvulsant therapy
Item
7. seizure disorders requiring anticonvulsant therapy
boolean
C0014544 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0521306 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic | Epidural space Neoplasm Metastasis Symptomatic | Exception Neoplasm Metastasis Well controlled
Item
8. symptomatic brain, leptomeningeal or epidural metastases (unless previously treated and well controlled for a period of ≥ 3 months)
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0014537 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0231220 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C3853142 (UMLS CUI [4,3])
Peripheral Neuropathy CTCAE Grades
Item
9. ongoing ctcae grade 2 or greater peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Prior Therapy Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated | Exception Cancer Other Disease Free of
Item
10. previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
boolean
C1514463 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1707251 (UMLS CUI [4,2])
C0012634 (UMLS CUI [4,3])
C0332296 (UMLS CUI [4,4])
Severe chronic obstructive pulmonary disease | Severe chronic lung disease | Hypoxemia | Requirement Oxygen supplementation | Symptoms Due to Hypoxemia | Oxygen saturation measurement Pulse Oximetry | Status post 2-Minute Walk Endurance Test | Physiological state Causing Hypoxemia Systemic | Physiological state Causing Hypoxemia regional
Item
11. severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia
boolean
C0730607 (UMLS CUI [1])
C3278799 (UMLS CUI [2])
C0700292 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0919655 (UMLS CUI [4,2])
C1457887 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0700292 (UMLS CUI [5,3])
C0523807 (UMLS CUI [6,1])
C0034108 (UMLS CUI [6,2])
C0231290 (UMLS CUI [7,1])
C4284677 (UMLS CUI [7,2])
C4062486 (UMLS CUI [8,1])
C0678227 (UMLS CUI [8,2])
C0700292 (UMLS CUI [8,3])
C0205373 (UMLS CUI [8,4])
C4062486 (UMLS CUI [9,1])
C0678227 (UMLS CUI [9,2])
C0700292 (UMLS CUI [9,3])
C0205147 (UMLS CUI [9,4])
Major surgery | Exception Diagnostic surgical procedure | Complete Recovery Lacking
Item
12. major surgery, other than diagnostic surgery, within 4 weeks prior to day 1, without complete recovery
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0522769 (UMLS CUI [2,2])
C2826210 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Requirement Systemic therapy
Item
13. active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
Therapeutic radiology procedure | Operative Surgical Procedures | Chemotherapy | Targeted Therapy | Hormone Therapy
Item
14. treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 4 weeks prior to study entry
boolean
C1522449 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C2985566 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
Cytotoxin Hypoxic
Item
15. prior therapy with an hypoxic cytotoxin
boolean
C0010868 (UMLS CUI [1,1])
C0242184 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
16. subjects who participated in an investigational drug or device study within 28 days prior to study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
HIV Infection | Hepatitis B | Hepatitis C
Item
17. known active infection with hiv, hepatitis b or c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Allergic Reaction Compound TH 302 Similar | Allergic Reaction Biological agent TH 302 Similar | Allergic Reaction Drug Formulation TH 302 Similar | Allergic Reaction Drug Formulation Containing Solutol HS 15 | Allergic Reaction Drug Formulation Containing Propylene glycol
Item
18. subjects who have exhibited allergic reactions to a structural compound, biological agent, or formulation (containing solutol and/or propylene glycol) similar to th-302
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C2348906 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0005515 (UMLS CUI [2,2])
C2348906 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C0524527 (UMLS CUI [3,2])
C2348906 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
C1527304 (UMLS CUI [4,1])
C0524527 (UMLS CUI [4,2])
C0332256 (UMLS CUI [4,3])
C0084586 (UMLS CUI [4,4])
C1527304 (UMLS CUI [5,1])
C0524527 (UMLS CUI [5,2])
C0332256 (UMLS CUI [5,3])
C0072225 (UMLS CUI [5,4])
Pregnancy | Breast Feeding
Item
19. females who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Comorbidity Study Subject Participation Status At risk | Condition Study Subject Participation Status At risk
Item
20. concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
Protocol Compliance Unwilling | Protocol Compliance Unable | Dose Expansion Cohort | Hormone refractory prostate cancer
Item
21. unwillingness or inability to comply with the study protocol for any reason expanded cohort subjects only: castrate-resistant prostate cancer
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C4521283 (UMLS CUI [3])
C1328504 (UMLS CUI [4])
Cytotoxic Chemotherapy | Radionuclide therapy | Dose Expansion Cohort | Second line treatment Non-Small Cell Lung Carcinoma
Item
1. prior treatment with cytotoxic chemotherapy or radioisotope therapy expanded cohort subjects only: second-line nsclc
boolean
C0677881 (UMLS CUI [1])
C0203608 (UMLS CUI [2])
C4521283 (UMLS CUI [3])
C1710038 (UMLS CUI [4,1])
C0007131 (UMLS CUI [4,2])
Cytotoxic Chemotherapy Quantity Advanced disease
Item
1. more than one prior cytotoxic chemotherapy regimen for advanced disease
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
Weight decreased Percentage
Item
2. weight loss of >10% body weight in the previous 6 weeks
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Pemetrexed plus TH 302 | Exclusion Criteria
Item
pemetrexed + th-302 exclusion criteria:
boolean
C0210657 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C2348906 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2])
Study Subject All
Item
all subjects:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Cytotoxic Chemotherapy Myelosuppressive Quantity
Item
1. prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
boolean
C0677881 (UMLS CUI [1,1])
C4330729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
pemetrexed
Item
2. prior treatment with pemetrexed
boolean
C0210657 (UMLS CUI [1])
Prior radiation therapy Bone Marrow Percentage
Item
3. prior radiotherapy to more than 25% of the bone marrow
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Unable to discontinue Non-Steroidal Anti-Inflammatory Agents | Creatinine clearance measurement | Status post Pemetrexed Dose
Item
4. inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or 2 days (short half-life, if subject has crcl <80 ml/min) before until 2 days following pemetrexed dosing
boolean
C1548265 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0210657 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
Heart Disease New York Heart Association Classification | Myocardial Infarction | Cardiac Arrhythmia Unstable | Peripheral Vascular Disease Arterial Symptomatic
Item
5. new york heart association (nyha) class iii or iv, cardiac disease, myocardial infarction within 6 months prior to day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0085096 (UMLS CUI [4,1])
C0221464 (UMLS CUI [4,2])
C0231220 (UMLS CUI [4,3])
Epilepsy Requirement Anticonvulsant therapy
Item
6. seizure disorders requiring anticonvulsant therapy
boolean
C0014544 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0521306 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic | Epidural space Neoplasm Metastasis Symptomatic | Exception Neoplasm Metastasis Well controlled
Item
7. symptomatic brain, leptomeningeal or epidural metastases (unless previously treated and well controlled for a period of ≥ 3 months)
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0014537 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0231220 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C3853142 (UMLS CUI [4,3])
Prior Therapy Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated | Exception Cancer Other Disease Free of
Item
8. previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
boolean
C1514463 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1707251 (UMLS CUI [4,2])
C0012634 (UMLS CUI [4,3])
C0332296 (UMLS CUI [4,4])
Severe chronic obstructive pulmonary disease | Severe chronic lung disease | Hypoxemia | Requirement Oxygen supplementation | Symptoms Due to Hypoxemia | Oxygen saturation measurement Pulse Oximetry | Status post 2-Minute Walk Endurance Test | Physiological state Causing Hypoxemia Systemic | Physiological state Causing Hypoxemia regional
Item
9. severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia
boolean
C0730607 (UMLS CUI [1])
C3278799 (UMLS CUI [2])
C0700292 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0919655 (UMLS CUI [4,2])
C1457887 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0700292 (UMLS CUI [5,3])
C0523807 (UMLS CUI [6,1])
C0034108 (UMLS CUI [6,2])
C0231290 (UMLS CUI [7,1])
C4284677 (UMLS CUI [7,2])
C4062486 (UMLS CUI [8,1])
C0678227 (UMLS CUI [8,2])
C0700292 (UMLS CUI [8,3])
C0205373 (UMLS CUI [8,4])
C4062486 (UMLS CUI [9,1])
C0678227 (UMLS CUI [9,2])
C0700292 (UMLS CUI [9,3])
C0205147 (UMLS CUI [9,4])
Major surgery | Exception Diagnostic surgical procedure | Complete Recovery Lacking
Item
10. major surgery, other than diagnostic surgery, within 4 weeks prior to day 1, without complete recovery
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0522769 (UMLS CUI [2,2])
C2826210 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Requirement Systemic therapy
Item
11. active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
Therapeutic radiology procedure | Operative Surgical Procedures | Chemotherapy | Targeted Therapy | Hormone Therapy
Item
12. treatment with radiation therapy, surgery, chemotherapy, targeted therapies or hormones within 4 weeks prior to study entry
boolean
C1522449 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C2985566 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
Cytotoxin Hypoxic
Item
13. prior therapy with an hypoxic cytotoxin
boolean
C0010868 (UMLS CUI [1,1])
C0242184 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
14. subjects who participated in an investigational drug or device study within 28 days prior to study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
HIV Infection | Hepatitis B | Hepatitis C
Item
15. known active infection with hiv, hepatitis b, or hepatitis c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Allergic Reaction Compound TH 302 Similar | Allergic Reaction Biological agent TH 302 Similar | Allergic Reaction Drug Formulation TH 302 Similar | Allergic Reaction Drug Formulation Containing Solutol HS 15 | Allergic Reaction Drug Formulation Containing Propylene glycol
Item
16. subjects who have exhibited allergic reactions to a structural compound, biological agent, or formulation (containing solutol and/or propylene glycol) similar to th-302
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C2348906 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0005515 (UMLS CUI [2,2])
C2348906 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C0524527 (UMLS CUI [3,2])
C2348906 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
C1527304 (UMLS CUI [4,1])
C0524527 (UMLS CUI [4,2])
C0332256 (UMLS CUI [4,3])
C0084586 (UMLS CUI [4,4])
C1527304 (UMLS CUI [5,1])
C0524527 (UMLS CUI [5,2])
C0332256 (UMLS CUI [5,3])
C0072225 (UMLS CUI [5,4])
Pregnancy | Breast Feeding
Item
17. females who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Comorbidity Study Subject Participation Status At risk | Condition Study Subject Participation Status At risk
Item
18. concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
Protocol Compliance Unwilling | Protocol Compliance Unable | Dose Expansion Cohort | Second line treatment Non-Small Cell Lung Carcinoma
Item
19. unwillingness or inability to comply with the study protocol for any reason expanded cohort subjects only: second-line nsclc
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C4521283 (UMLS CUI [3])
C1710038 (UMLS CUI [4,1])
C0007131 (UMLS CUI [4,2])
Cytotoxic Chemotherapy Quantity Advanced disease | Weight decreased Percentage
Item
1. more than one prior cytotoxic chemotherapy regimen for advanced disease 2. weight loss of >10% body weight in the previous 6 weeks
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C1262477 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
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