Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label, two way crossover study designed to test the
bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients
with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate
that those 2 formulations are considered to be the same for all intents and purposes by
making sure they are acting on the body with the same strength and are absorbed in similar
amounts by the body. During the bioequivalence phase, patients will take orally at a daily
dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days
on/2days off dosing schedule, after which time, patients will switch to the alternate
formulation for one additional week. After the bioequivalence phase, all patients may
continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until
disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation
from the study treatment for any other reason.