Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: TAS-102; Drug: Trifluridine

• Registration Number: NCT01867866
• Lead Sponsor: Taiho Oncology, Inc.

Brief Summary

The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.

Detailed Description

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-04
• Primary Completion: 2013-10
• Study Completion: 2016-06
• Status Verified: 2017-09
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Has provided written informed consent
2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
3. ECOG performance status of 0 or 1
4. Is able to take medications orally
5. Has adequate organ function (bone marrow, kidney and liver)
6. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria

1. Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
2. Certain serious illnesses or medical condition(s)
3. Has had either partial or total gastrectomy
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
5. Known sensitivity to TAS-102 or its components
6. Is a pregnant or lactating female
7. Refuses to use an adequate means of contraception (including male patients)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAS-102	TAS-102	-
FTD (Trifluridine)	Trifluridine	-

Primary Outcome Measures

Name	Time	Method
FTD pharmacokinetic parameters AUC0-last and Cmax	Day 1 of Cycle 1

Secondary Outcome Measures

Name	Time	Method
FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F	Day 1 of Cycle 1
FTY and TPI pharmacokinetic parameters AUC0-last, Cmax, AUC0-inf, Tmax, T1/2, CL/F, and Vd/F	Day 1 of Cycle 1
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	Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.
Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)	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.
Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2	Day 12 of Cycles 1, 2, and 3

Trial Locations

Locations (1)

South Texas Accelerated Research Therapeutics, LLC; 🇺🇸 San Antonio, Texas, United States