Age
Item
participants must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Colorectal cancer metastatic | Recurrent Head and Neck Carcinoma | Head and neck cancer metastatic | Oesophageal carcinoma recurrent | Esophageal neoplasm metastatic | Non-Small Cell Lung Carcinoma Advanced Locally | Non-Small Cell Lung Carcinoma Inoperable | Non-small cell lung cancer metastatic
Item
participants must have metastatic colorectal cancer (crc), recurrent or metastatic head & neck (h&n) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (nsclc).
boolean
C0948380 (UMLS CUI [1])
C1335703 (UMLS CUI [2])
C0744619 (UMLS CUI [3])
C0854761 (UMLS CUI [4])
C0278562 (UMLS CUI [5])
C0007131 (UMLS CUI [6,1])
C0205179 (UMLS CUI [6,2])
C1517927 (UMLS CUI [6,3])
C0007131 (UMLS CUI [7,1])
C0205187 (UMLS CUI [7,2])
C0278987 (UMLS CUI [8])
Tumor tissue sample Test Positive Biomarker | Blood specimen Test Positive Biomarker
Item
participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.
boolean
C0475358 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0005516 (UMLS CUI [1,4])
C0178913 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0005516 (UMLS CUI [2,4])
Prior Therapy Quantity Colorectal Carcinoma | Prior Therapy Quantity Non-Small Cell Lung Carcinoma | Prior Therapy Quantity Cancer of Head and Neck | Prior Therapy Quantity Esophageal carcinoma
Item
participants may have up to 3 prior regimens for crc, up to 3 prior regimens for nsclc, up to 2 prior regimens for h&n and esophageal cancer.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
C1514463 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0278996 (UMLS CUI [3,3])
C1514463 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0152018 (UMLS CUI [4,3])
Measurable lesion Quantity
Item
participants must have at least one measurable lesion.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
participants must have an eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
participants must have adequate hematologic, renal, and liver functions.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Able to swallow Oral Capsule | Intake Capsule Feeding tube
Item
participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened.
boolean
C2712086 (UMLS CUI [1,1])
C0991533 (UMLS CUI [1,2])
C1512806 (UMLS CUI [2,1])
C0006935 (UMLS CUI [2,2])
C2945625 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods
Item
participants of childbearing potential must agree to use a medically accepted method of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Therapeutic procedure Second Cancer | At risk Recurrent disease
Item
participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.
boolean
C0087111 (UMLS CUI [1,1])
C0751623 (UMLS CUI [1,2])
C1444641 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
CNS metastases Unstable | CNS metastases Progressing | Exception Study Subject Asymptomatic | Exception Steroids Redundant | Exception Anticonvulsants Redundant | Exception Pharmaceutical Preparations Dosage Stable | Exception Midline Shift Absent | Exception Edema Absent
Item
participants with unstable or progressing central nervous system (cns) metastasis. participants with known cns metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.
boolean
C0686377 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0681850 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C1313915 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0003286 (UMLS CUI [5,2])
C1313915 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C0178602 (UMLS CUI [6,3])
C0205360 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C4086580 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0013604 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
temozolomide | Dacarbazine
Item
participants who received prior temozolomide or dacarbazine treatment
boolean
C0076080 (UMLS CUI [1])
C0010927 (UMLS CUI [2])