Pharmacokinetics of Tivantinib in Subjects With Advanced Solid Tumors and Hepatic Impairment (NCT02150733) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics of Tivantinib in Subjects With Advanced Solid Tumors and Hepatic Impairment
United States29 participantsStarted 2014-04
Plain-language summary
This is a multi-center, open-label, Phase 1 study to evaluate the impact of hepatic impairment on the pharmacokinetics of Tivantinib in cancer subjects with varying degrees of hepatic function, from normal to severely impaired.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must have histologically or cytologically confirmed advanced solid tumor. However, Hepatocellular Carcinoma (HCC) subjects are allowed without histological confirmation as long as there is radiological diagnosis as per standard criteria
✓. Male or female ≥18 years of age
✓. Life expectancy of \>12 weeks
✓. Women of childbearing potential (WOCBP) must have a negative pregnancy test performed prior to the start of study drug
✓. Male subjects and WOCBP must agree to use double barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug
✓. Subjects with impaired hepatic function will be grouped according to Child-Pugh classification score
✓. Subjects with biliary obstruction for whom a biliary drain or stent has been placed are eligible, provided that the drain or stent has been in place for at least 10 days prior to the first dose of Tivantinib, and the subject's liver function has stabilized as defined by 2 measurements at least 5 days apart that put the subject in the same hepatic impairment group
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
Exclusion criteria
✕. History of liver transplant
✕. Any major surgical procedure within 3 weeks prior to the first dose of study drug;
✕
What they're measuring
1
Composite of plasma pharmacokinetic parameters of Tivantinib
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours after a single dose and 0 (predose), 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours after Cycle 1 Day 11 dose
. Active, clinically serious infections defined as ≥Grade 2 according to NCI Common Toxicity Criteria for Adverse Effects (CTCAE), version 4.0
✕. Known metastatic brain or meningeal tumors, unless the subject is \>3 months from definitive therapy and clinically stable (supportive therapy with steroids or anticonvulsant medications is allowed) with respect to the tumor at the time of the first dose of study drug
✕. History of cardiac disease
✕. Any condition that is unstable or that could jeopardize the safety of the subject and the subject's protocol compliance, including known infection with human immunodeficiency virus
✕. Significant gastrointestinal disorders, in the opinion of the Investigator