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Completed

NCT Number: NCT01867866

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

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

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

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.

Trifluridine

Drug

35 mg/m2, orally, single dose

Primary outcomes

  1. FTD pharmacokinetic parameters AUC0-last and Cmax

    Time frame: Day 1 of Cycle 1

Secondary outcomes

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

    Time frame: Day 1 of Cycle 1

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

    Time frame: Day 1 of Cycle 1

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

    Time frame: Day 12 of Cycles 1, 2, and 3

  4. Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: 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.

  5. Safety monitoring including adverse events, vital signs, and laboratory assessments

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taiho Oncology, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2016
First posted
Jun 4, 2013
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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