A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment
- Registration Number
- NCT02301104
- Lead Sponsor
- Taiho Oncology, Inc.
- Brief Summary
Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of hepatic impairment.
- Detailed Description
This is a Phase 1, open-label study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors with varying degrees of hepatic impairment. The study is conducted in 2 parts: the Pharmacokinetic Part (Cycle 1) and the Extension Part (Cycles 2 and beyond). Patients may continue to receive treatment with TAS-102 during the study extension part only after completion of the Pharmacokinetic Part.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mild Hepatic Impairment TAS-102 35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met. Severe Hepatic Impairment TAS-102 35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met. The dose level of severe cohort, if enrolled, will be determined based on the Interim Assessment of mild and moderate cohorts. Moderate Hepatic Impairment TAS-102 35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met. Normal Hepatic Function TAS-102 35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
- Primary Outcome Measures
Name Time Method PK parameters of FTD, FTY, and TPI in plasma after a single dose of TAS-102 Blood samples will be collected in Cycle 1 Day 1 and Day 12 at pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours post AM dose of TAS-102 FTD, FTY and TPI: pharmacokinetic parameters Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. FTD and TPI: CL/F, Vd/F of TAS-102
Safety monitoring including adverse events, vital signs, and laboratory assessments Through 30 days following last administration of study medication or until initiation of new anticancer treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Dallas Clinical Site
🇺🇸Dallas, Texas, United States
Pittsburgh Clinical Site
🇺🇸Pittsburgh, Pennsylvania, United States
Cleveland Clinical Site
🇺🇸Cleveland, Ohio, United States
Boston Clinical Site
🇺🇸Boston, Massachusetts, United States
Duarte Clinical Site
🇺🇸Duarte, California, United States
Baltimore Clinical Site
🇺🇸Baltimore, Maryland, United States
Santa Monica Clinical Site
🇺🇸Santa Monica, California, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States