A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment
- Registration Number
- NCT02301117
- 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 renal 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 renal 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
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Severe Renal 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 will be determined based on the Interim Assessment of mild and moderate cohorts Mild Renal 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. Moderate Renal 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 Renal 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 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 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, FTY, and TPI: Ae% and CLr. FTD and TPI: CL/F, Vd/F of TAS-102
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Phoenix Clinical Site
🇺🇸Phoenix, Arizona, United States
Duarte Clinical Site
🇺🇸Duarte, California, United States
Santa Monica Clinical Site
🇺🇸Santa Monica, California, United States
Gainesville Clinical Site
🇺🇸Gainesville, Florida, United States
Baltimore Clinical Site
🇺🇸Baltimore, Maryland, United States
Boston Clinical Site
🇺🇸Boston, Massachusetts, United States
Cleveland Clinical Site
🇺🇸Cleveland, Ohio, United States
Pittsburgh Clinical Site
🇺🇸Pittsburgh, Pennsylvania, United States
Dallas Clinical Site
🇺🇸Dallas, Texas, United States
Brno Clinical Site
🇨🇿Brno, Czechia
Scroll for more (3 remaining)Phoenix Clinical Site🇺🇸Phoenix, Arizona, United States