Breast Cancer Clinical Trial
Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI
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.
Full 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 tumors. This study will be conducted in 2 parts. The crossover bioavailability part will be followed by an extension conducted with TAS-102 tablets only.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
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There is 1 Location for this study
Scottsdale Arizona, 85258, United States
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