Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone
The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone|
- FTD pharmacokinetic parameters AUC0-last and Cmax [ Time Frame: Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
- FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F [ Time Frame: Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
- FTY and TPI pharmacokinetic parameters AUC0-last, Cmax, AUC0-inf, Tmax, T1/2, CL/F, and Vd/F [ Time Frame: Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
- Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2 [ Time Frame: Day 12 of Cycles 1, 2, and 3 ] [ Designated as safety issue: No ]
- Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Every 8 weeks through Cycle 6 (ie, through 24 weeks). Thereafter, assessments will be performed at least every 12 weeks according to site standard of care, until at least one of the treatment discontinuation criteria is met. ] [ Designated as safety issue: No ]
- Safety monitoring including adverse events, vital signs, and laboratory assessments [ Time Frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment ] [ Designated as safety issue: Yes ]Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
|Experimental: FTD (Trifluridine)||
35 mg/m2, orally, single dose
This is a Phase 1, open-label, randomized, parallel, 2-group study evaluating the PK of FTD as a TAS-102 component compared with FTD alone in patients with advanced solid tumors (excluding breast cancer). Patients will be randomized to receive a single dose of TAS-102 or FTD during the PK contribution phase and will receive continuing cycles of TAS-102 during the extension phase.
|United States, Texas|
|South Texas Accelerated Research Therapeutics, LLC|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Drew Rasco, MD||South Texas Accelerated Research Therapeutics, LLC|