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

NCT ID: NCT01874522

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-11-30

Brief 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.

Conditions

Advanced Solid Tumors (Excluding Breast Cancer)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAS-102 tablets

Group Type: EXPERIMENTAL

TAS-102 tablets

Intervention Type: DRUG

Crossover bioavailability part: 60 mg/dose, orally, up to 2 single doses separated by 1-week washout.

Extension part: 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.

TAS-102 oral solution

Group Type: EXPERIMENTAL

TAS-102 oral solution

Intervention Type: DRUG

60 mg/dose, orally, up to 2 single doses separated by 1-week washout

Interventions

TAS-102 tablets

Crossover bioavailability part: 60 mg/dose, orally, up to 2 single doses separated by 1-week washout.

Extension part: 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.

Intervention Type: DRUG

TAS-102 oral solution

60 mg/dose, orally, up to 2 single doses separated by 1-week washout

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Von Hoff, MD

Role: PRINCIPAL_INVESTIGATOR

Scottsdale Healthcare

Locations

Scottsdale Healthcare

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

TPU-TAS-102-104

Identifier Type: -

Identifier Source: org_study_id