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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01867866
First received: May 24, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Advanced Solid Tumors
Drug: TAS-102
Drug: Trifluridine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Taiho Oncology, Inc.:

Primary Outcome Measures:
  • FTD pharmacokinetic parameters AUC0-last and Cmax [ Time Frame: Day 1 of Cycle 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F [ Time Frame: Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2 [ Time Frame: Day 12 of Cycles 1, 2, and 3 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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.


Estimated Enrollment: 40
Study Start Date: June 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867866

Locations
United States, Texas
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Taiho Oncology, Inc.
Investigators
Principal Investigator: Drew Rasco, MD South Texas Accelerated Research Therapeutics, LLC
  More Information

No publications provided

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01867866     History of Changes
Other Study ID Numbers: TPU-TAS-102-102
Study First Received: May 24, 2013
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Trifluridine
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014