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

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867866
• Other study ID #: TPU-TAS-102-102
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2013
• Last updated: September 29, 2017
• Start date: May 2013
• Est. completion date: June 2016

Study information

• Verified date: September 2017
• Source: Taiho Oncology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2016
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• TAS-102
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.
• Trifluridine
35 mg/m2, orally, single dose

Locations

Country	Name	City	State
United States	South Texas Accelerated Research Therapeutics, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FTD pharmacokinetic parameters AUC0-last and Cmax		Day 1 of Cycle 1
Secondary	FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F		Day 1 of Cycle 1
Secondary	FTY and TPI pharmacokinetic parameters AUC0-last, Cmax, AUC0-inf, Tmax, T1/2, CL/F, and Vd/F		Day 1 of Cycle 1
Secondary	Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2		Day 12 of Cycles 1, 2, and 3
Secondary	Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)		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.
Secondary	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