A Phase 1, Open-label, Randomized, Crossover Study Evaluating the Bioavailability of TAS-102 Tablets Relative to an Oral Solution Containing Equivalent Amounts of FTD and TPI
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.
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (Cmax)
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Day 1 of Periods 1, 2, and 3
Daniel Von Hoff, MD
United States: Food and Drug Administration
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