Liver carcinoma | FGF19 gene Amplification
Item
histologically or cytologically confirmed hepatocellular carcinoma (hcc). for part 2, hcc participants must have fibroblast growth factor (fgf) 19 amplification in addition
boolean
C2239176 (UMLS CUI [1])
C1414603 (UMLS CUI [2,1])
C0017256 (UMLS CUI [2,2])
Advanced disease | Disease Ineligible Operative Surgical Procedures | Disease Ineligible Therapy Local-Regional | Disease Ineligible Systemic therapy | Disease Progression Post Operative Surgical Procedures | Disease Progression Post Therapy Local-Regional | Systemic therapy Quantity
Item
participant must have advanced disease: disease ineligible for surgical or local-regional therapy or systemic therapy; disease progression after surgical or local-regional therapy; received no more than 1 line of systemic therapy
boolean
C0679246 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1512714 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1947913 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C1512714 (UMLS CUI [4,2])
C1515119 (UMLS CUI [4,3])
C0242656 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0543467 (UMLS CUI [5,3])
C0242656 (UMLS CUI [6,1])
C0687676 (UMLS CUI [6,2])
C0087111 (UMLS CUI [6,3])
C1947913 (UMLS CUI [6,4])
C1515119 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status score 0 or 1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function | Electrolytes
Item
adequate bone marrow, liver, renal function, and electrolytes according to protocol-defined criteria within the 14 days preceding the first dose of study drug
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0013832 (UMLS CUI [4])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
negative pregnancy test (urinary or serum beta human chorionic gonadotropin [beta (b)-hcg]) at screening for women of child bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430060 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Systemic Chemotherapy | Targeted Therapy | Therapeutic radiology procedure | Immunotherapy | Antineoplastic Agents Investigational | Nitrosoureas | Mitomycin
Item
received systemic chemotherapy, targeted therapies, definitive radiotherapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug, whichever is longer (in the case of nitrosoureas and mitomycin c, within 6 weeks) before the first administration of study drug
boolean
C1883256 (UMLS CUI [1])
C2985566 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0003392 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C0028210 (UMLS CUI [6])
C0002475 (UMLS CUI [7])
Transplantation of liver
Item
prior liver transplant
boolean
C0023911 (UMLS CUI [1])
Fibrolamellar Hepatocellular Carcinoma | Combined Hepatocellular Carcinoma and Cholangiocarcinoma
Item
known fibrolamellar hcc or mixed cholangiocarcinoma and hcc
boolean
C0334287 (UMLS CUI [1])
C0221287 (UMLS CUI [2])
Communicable Diseases Serious CTCAE Grades
Item
clinically active serious infections greater than (>) common terminology criteria for adverse events (aes) grade 2
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Ca++ increased Persistent | Phosphate increased Persistent
Item
participants with persistent calcium or phosphate > upper limits of normal (uln) during screening (within 14 days prior to day 1 of cycle 1 up until pre-dose of cycle 1) and despite medical management of calcium or phosphate levels
boolean
C0553702 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0860988 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])