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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01874522
First received: June 4, 2013
Last updated: May 27, 2014
Last verified: February 2014

June 4, 2013
May 27, 2014
July 2013
June 2014   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Same as current
Complete list of historical versions of study NCT01874522 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
  • Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution [ Time Frame: Day 1 of Periods 1, 2, and 3 ] [ Designated as safety issue: No ]
    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
  • 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 ] [ Designated as safety issue: Yes ]
    Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.
  • 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI
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

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors (Excluding Breast Cancer)
  • 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.

  • Drug: TAS-102 oral solution
    60 mg/dose, orally, up to 2 single doses separated by 1-week washout
  • Experimental: TAS-102 tablets
    Intervention: Drug: TAS-102 tablets
  • Experimental: TAS-102 oral solution
    Intervention: Drug: TAS-102 oral solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
August 2014
June 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01874522
TPU-TAS-102-104
No
Taiho Oncology, Inc.
Taiho Oncology, Inc.
Not Provided
Principal Investigator: Daniel Von Hoff, MD Scottsdale Healthcare
Taiho Oncology, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP