Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors.
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label, single-sequence, crossover, drug-drug interaction (DDI)
study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on the PK of dovitinib in
patients with advanced solid tumors, excluding breast cancer. The purpose of this study is to
evaluate the effect of a CYP1A2 inhibitor, 100 mg fluvoxamine, on the PK of dovitinib when
administered at a dose of 300 mg on the dosing schedule, 5 days on/2 days off. The study will
consist of 2 phases: a Pharmacokinetic (PK) phase and a clinical treatment phase. The DDI
test will be conducted in the PK phase. The DDI test will assess the steady state PK profile
of dovitinib when administered alone and in the presence of the CYP1A2 inhibitor, fluvoxamine
(AUC 0-24h, AUC 0-72h and Cmax parameters). During the clinical treatment phase patients may
continue to receive treatment with TKI258 until disease progression (assessed by RECIST 1.1),
unacceptable toxicity, death or discontinuation from the study treatment for any other
reason.