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

Taiho Oncology, Inc.44 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors

Interventions

TAS-102DRUG

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.

TrifluridineDRUG

35 mg/m2, orally, single dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

Outcomes

Primary Outcomes

FTD pharmacokinetic parameters AUC0-last and Cmax

Time frame: Day 1 of Cycle 1

Secondary Outcomes

FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F

Time frame: Day 1 of Cycle 1

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

Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2

Time frame: Day 12 of Cycles 1, 2, and 3

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.

Safety monitoring including adverse events, vital signs, and laboratory assessments

Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.

Time frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment

Data from ClinicalTrials.gov

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