Status:
COMPLETED
Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Advanced Solid Tumors (Excluding Breast Cancer)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral solution containing equivalent amounts FTD and TPI.
Detailed Description
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 ...
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 :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01874522
Start Date
July 1 2013
End Date
November 1 2015
Last Update
September 5 2024
Active Locations (1)
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1
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258