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Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI | Clinical Trials | Clareo Health

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Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI

A Phase 1, Open-label, Randomized, Crossover Study Evaluating the Bioavailability of TAS-102 Tablets Relative to an Oral Solution Containing Equivalent Amounts of FTD and TPI

NCT01874522•Taiho Oncology, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral solution containing equivalent amounts FTD and TPI.

Detailed Description

This is a Phase 1, open-label, randomized, 2-sequence, 3-period crossover study evaluating the relative bioavailability of TAS-102 tablets compared to an oral solution in patients with advanced solid tumors. This study will be conducted in 2 parts. The crossover bioavailability part will be followed by an extension conducted with TAS-102 tablets only.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

Scottsdale Healthcare

Scottsdale, Arizona, United States

Key Dates

Start Date

July 1, 2013

Primary Completion Date

August 1, 2015

Completion Date

November 1, 2015

Last Updated

September 5, 2024

Enrollment

ACTUAL participants

Conditions

Advanced Solid Tumors (Excluding Breast Cancer)

Interventions

TAS-102 tablets

DRUG

TAS-102 oral solution

DRUG