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Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI

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ClinicalTrials.gov Identifier: NCT01874522
Recruitment Status : Completed
First Posted : June 11, 2013
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors (Excluding Breast Cancer) Drug: TAS-102 tablets Drug: TAS-102 oral solution Phase 1

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  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874522


Locations
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
Taiho Oncology, Inc.
Investigators
Principal Investigator: Daniel Von Hoff, MD Scottsdale Healthcare

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01874522     History of Changes
Other Study ID Numbers: TPU-TAS-102-104
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015

Keywords provided by Taiho Oncology, Inc.:
Advanced solid tumors (excluding breast cancer) for which no standard therapy exists

Additional relevant MeSH terms:
Pharmaceutical Solutions
Trifluridine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents