ID

31139

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00743379

Nyckelord

Non Small Cell Lung Cancer

D016430

Pulmonale Krankheiten (Fachgebiet)

Eligibility Determination

2018-07-23 2018-07-23 -

Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 juli 2018

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Non-Small Cell Lung Cancer NCT00743379

model
Detaljer

Eligibility Non-Small Cell Lung Cancer NCT00743379

1 Formulär

StudyEvent: Eligibility
1. Eligibility Non-Small Cell Lung Cancer NCT00743379

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Criteria

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])

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])

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

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])

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])

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

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

boolean

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])

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

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])

Item

8. symptomatic brain, leptomeningeal or epidural metastases (unless previously treated and well controlled for a period of ≥ 3 months)

boolean

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

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

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

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])

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

Pregnancy | Breast Feeding

Item

19. females who are pregnant or breast-feeding

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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

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

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])

Item

7. symptomatic brain, leptomeningeal or epidural metastases (unless previously treated and well controlled for a period of ≥ 3 months)

boolean

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

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

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

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])

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

Pregnancy | Breast Feeding

Item

17. females who are pregnant or breast-feeding

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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

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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Eligibility Non-Small Cell Lung Cancer NCT00743379

Eligibility Non-Small Cell Lung Cancer NCT00743379

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