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

Information source: Taiho Oncology, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Solid Tumors

Intervention: TAS-102 (Drug); Trifluridine (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Taiho Oncology, Inc.

Official(s) and/or principal investigator(s):
Drew Rasco, MD, Principal Investigator, Affiliation: South Texas Accelerated Research Therapeutics, LLC

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: FTD pharmacokinetic parameters AUC0-last and Cmax

Secondary outcome:

FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F

FTY and TPI pharmacokinetic parameters AUC0-last, Cmax, AUC0-inf, Tmax, T1/2, CL/F, and Vd/F

Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2

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

Safety monitoring including adverse events, vital signs, and laboratory assessments

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas 78229, United States
Additional Information

Starting date: June 2013
Last updated: January 7, 2014

Page last updated: August 23, 2015

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