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

Phase 1

Completed

• Conditions: Advanced Solid Tumors (Excluding Breast Cancer)
• Interventions: Drug: TAS-102 oral solution; Drug: TAS-102 tablets

• Registration Number: NCT01874522
• Lead Sponsor: Taiho Oncology, Inc.

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.

Study Timeline

• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-11
• Study Start: 2013-07
• Primary Completion: 2015-08
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TAS-102 oral solution	TAS-102 oral solution	-
TAS-102 tablets	TAS-102 tablets	-

Primary Outcome Measures

Name	Time	Method
Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (Cmax)	Day 1 of Periods 1, 2, and 3	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (AUC0-last)	Day 1 of Periods 1, 2, and 3	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (AUC0-inf )	Day 1 of Periods 1, 2, and 3	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

Secondary Outcome Measures

Name	Time	Method
Tmax of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution	Day 1 of Periods 1, 2, and 3	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
T1/2 of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution	Day 1 of Periods 1, 2, and 3	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
CL/F of FTD and TPI following administration of TAS 102 tablet and oral solution	Day 1 of Periods 1, 2, and 3	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Vd/F of FTD and TPI following administration of TAS 102 tablet and oral solution	Day 1 of Periods 1, 2, and 3	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution	Day 1 of Periods 1, 2, and 3	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
AUC0-last of metabolites of FTD following administration of TAS 102 tablet and oral solution	Day 1 of Periods 1, 2, and 3	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
AUC0-inf of metabolites of FTD following administration of TAS 102 tablet and oral solution	Day 1 of Periods 1, 2, and 3	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
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 during the extension period 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.

Trial Locations

Locations (1)

Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States