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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors (Excluding Breast Cancer)
• Intervention / Treatment: Drug: TAS-102 tablets; Drug: TAS-102 oral solution

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAS-102 tablets	Drug: 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.
Experimental: TAS-102 oral solution	Drug: TAS-102 oral solution; 60 mg/dose, orally, up to 2 single doses separated by 1-week washout

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (Cmax)	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.	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)	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.	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 )	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.	Day 1 of Periods 1, 2, and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Tmax of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.	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	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.	Day 1 of Periods 1, 2, and 3
CL/F of FTD and TPI following administration of TAS 102 tablet and oral solution	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.	Day 1 of Periods 1, 2, and 3
Vd/F of FTD and TPI following administration of TAS 102 tablet and oral solution	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.	Day 1 of Periods 1, 2, and 3
Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.	Day 1 of Periods 1, 2, and 3
AUC0-last of metabolites of FTD following administration of TAS 102 tablet and oral solution	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.	Day 1 of Periods 1, 2, and 3
AUC0-inf of metabolites of FTD following administration of TAS 102 tablet and oral solution	Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.	Day 1 of Periods 1, 2, and 3
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.

Collaborators and Investigators

• Sponsor: Taiho Oncology, Inc.
• Investigators: Principal Investigator: Daniel Von Hoff, MD, Scottsdale Healthcare

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimated): June 11, 2013

Study Record Updates

• Last Update Posted (Actual): September 5, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: TPU-TAS-102-104