Solid Neoplasm Advanced Locally | Solid Neoplasm metastatic | Standard therapy Lacking | Standard therapy ineffective | Intolerance Standard therapy
Item
documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)
boolean
C0280100 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0280100 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C3242229 (UMLS CUI [4,2])
C0231199 (UMLS CUI [5,1])
C2936643 (UMLS CUI [5,2])
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Prior Chemotherapy Quantity failed Incurable disease
Item
documented locally advanced or metastatic nsclc in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
C1514457 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
C0175969 (UMLS CUI [3,4])
Organ function Laboratory tests
Item
adequate organ function as assessed by laboratory tests
boolean
C0678852 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Evaluable Disease | Measurable Disease
Item
evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist)
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Contraceptive methods Agreement
Item
agreement to use an effective form of contraception for the duration of the study
boolean
C0700589 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Cancer treatment | Chemotherapy | Biological treatment | Hormone Therapy
Item
any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
PI3k Inhibitor
Item
prior treatment with pi3k pathway-inhibiting agents (cohort-expansion stage only)
boolean
C0044602 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
Fasting hyperglycaemia Grade | Diabetes Mellitus Requirement Pharmaceutical Preparations Regular
Item
history of grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
boolean
C2609269 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0205272 (UMLS CUI [2,4])
Systemic disease Uncontrolled | Cardiovascular Disease | Lung disease | Metabolic Disease
Item
current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
Cardiac dysfunction | Pulmonary Dysfunction
Item
history of clinically significant cardiac or pulmonary dysfunction
boolean
C3277906 (UMLS CUI [1])
C1709770 (UMLS CUI [2])
Malabsorption Syndrome | Condition Interferes with Intestinal Absorption
Item
history of malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021826 (UMLS CUI [2,3])
Liver disease
Item
clinically significant history of liver disease
boolean
C0023895 (UMLS CUI [1])
Condition Requirement Anticoagulants Dose Full | Warfarin | Heparin | Fibrinolytic Agents
Item
any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C0443225 (UMLS CUI [1,5])
C0043031 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
C0016018 (UMLS CUI [4])
Autoimmune Disease | Patient need for Steroid therapy
Item
active autoimmune disease and/or need for corticosteroid therapy
boolean
C0004364 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0149783 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Treatment required for
Item
known brain metastases that are untreated, symptomatic, or require therapy
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
Pregnancy | Lactation | Breast Feeding
Item
pregnancy, lactation, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0006147 (UMLS CUI [3])