Pharmacokinetic Drug-drug Interaction Study of Dovitinib (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, phase I study to assess the effects of dovitinib (TKI258)
on the pharmacokinetics of a cocktail of caffeine, diclofenac, omeprazole and midazolam in
patients with advanced solid tumors, excluding breast cancer. The aim of this study is to
evaluate the potential effect of dovitinib (TKI258) on the metabolism of the probe drugs
caffeine, diclofenac, omeprazole and midazolam, which are metabolized by CYP1A2, CYP2C9,
CYP2C19 and CYP3A4 respectively (Cytochrome P450 isoenzyme), comparing the single-dose
pharmacokinetics (AUCtlast, AUCinf and Cmax parameters) of each of the individual probe drug
co-administered with and without multiple dose of dovitinib (TKI258) 500 mg under a 5 days on
/ 2 days off dose schedule. The study foresees two treatment phases: DDI (drug-drug
interaction) followed by post-DDI. During the DDI phase patients receive treatment with the
probe drug cocktail and dovitinib (TKI258). During the post-DDI phase patients may continue
to receive treatment with dovitinib (TKI258) until disease progression (assessed by RECIST
1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other
reason.