Status:
COMPLETED
Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.
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 canc...
Eligibility Criteria
Inclusion
- Has provided written informed consent
- Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
- ECOG performance status of 0 or 1
- Is able to take medications orally
- Has adequate organ function (bone marrow, kidney and liver)
- 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
- Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
- Certain serious illnesses or medical condition(s)
- Has had either partial or total gastrectomy
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- Known sensitivity to TAS-102 or its components
- Is a pregnant or lactating female
- Refuses to use an adequate means of contraception (including male patients)
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01867866
Start Date
May 1 2013
End Date
June 1 2016
Last Update
September 5 2024
Active Locations (1)
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1
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229