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

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ClinicalTrials.gov Identifier: NCT01867866
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: TAS-102 Drug: Trifluridine Phase 1

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAS-102 Drug: TAS-102
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: FTD (Trifluridine) Drug: Trifluridine
35 mg/m2, orally, single dose


Outcome Measures
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Primary Outcome Measures :
  1. FTD pharmacokinetic parameters AUC0-last and Cmax [ Time Frame: Day 1 of Cycle 1 ]

Secondary Outcome Measures :
  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.


Eligibility Criteria
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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)
Contacts and Locations
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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): NCT01867866


Locations
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United States, Texas
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Taiho Oncology, Inc.
Investigators
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Principal Investigator: Drew Rasco, MD South Texas Accelerated Research Therapeutics, LLC
More Information
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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01867866    
Other Study ID Numbers: TPU-TAS-102-102
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Keywords provided by Taiho Oncology, Inc.:
Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
Additional relevant MeSH terms:
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Trifluridine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents