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])