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Completed

NCT Number: NCT01874522

Study Comparing the Bioavailability of TAS-102 Tablets 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.

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Key information

Conditions

Advanced Solid Tumors (Excluding Breast Cancer)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

About this study

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.

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 tablets

Drug

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.

TAS-102 oral solution

Drug

60 mg/dose, orally, up to 2 single doses separated by 1-week washout

Primary outcomes

  1. Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (Cmax)

    Time frame: Day 1 of Periods 1, 2, and 3

    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

  2. Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (AUC0-last)

    Time frame: Day 1 of Periods 1, 2, and 3

    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

  3. Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (AUC0-inf )

    Time frame: Day 1 of Periods 1, 2, and 3

    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

Secondary outcomes

  1. Tmax of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution

    Time frame: Day 1 of Periods 1, 2, and 3

    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

  2. T1/2 of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution

    Time frame: Day 1 of Periods 1, 2, and 3

    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

  3. CL/F of FTD and TPI following administration of TAS 102 tablet and oral solution

    Time frame: Day 1 of Periods 1, 2, and 3

    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

  4. Vd/F of FTD and TPI following administration of TAS 102 tablet and oral solution

    Time frame: Day 1 of Periods 1, 2, and 3

    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

  5. Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution

    Time frame: Day 1 of Periods 1, 2, and 3

    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

  6. AUC0-last of metabolites of FTD following administration of TAS 102 tablet and oral solution

    Time frame: Day 1 of Periods 1, 2, and 3

    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

  7. AUC0-inf of metabolites of FTD following administration of TAS 102 tablet and oral solution

    Time frame: Day 1 of Periods 1, 2, and 3

    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

  8. 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taiho Oncology, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 11, 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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