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

NCT01867866 | Completed Phase 1

• 1 other identifier: TPU-TAS-102-102
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumors

Keywords

Advanced solid tumors (excluding breast cancer) for which no standard therapy exists

Outcome Measures

Primary Outcomes (1)

• FTD pharmacokinetic parameters AUC0-last and Cmax

  Day 1 of Cycle 1

Secondary Outcomes (5)

• FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F

  Day 1 of Cycle 1

• FTY and TPI pharmacokinetic parameters AUC0-last, Cmax, AUC0-inf, Tmax, T1/2, CL/F, and Vd/F

  Day 1 of Cycle 1

• Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2

  Day 12 of Cycles 1, 2, and 3

• 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.

• 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

Study Arms (2)

TAS-102

EXPERIMENTAL

Drug: TAS-102

FTD (Trifluridine)

EXPERIMENTAL

Drug: Trifluridine

Interventions

TAS-102 DRUG

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

Trifluridine DRUG

35 mg/m2, orally, single dose

FTD (Trifluridine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided written informed consent
• Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
• ECOG performance status of 0 or 1
• Is able to take medications orally
• Has adequate organ function (bone marrow, kidney and liver)
• 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.

You may not qualify if:

• Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
• Certain serious illnesses or medical condition(s)
• Has had either partial or total gastrectomy
• Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
• Known sensitivity to TAS-102 or its components
• Is a pregnant or lactating female
• Refuses to use an adequate means of contraception (including male patients)

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (1)

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

trifluridine tipiracil drug combination; Trifluridine

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Drew Rasco, MD

  South Texas Accelerated Research Therapeutics, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2016
• Last Updated: September 5, 2024

Record last verified: 2024-08

Locations

US (1)