Who is sponsoring NCT01596647?

NCT01596647 is sponsored by Novartis Pharmaceuticals.

What condition does NCT01596647 study?

NCT01596647 studies Advanced Solid Tumors, Excluding Breast Cancer.

What drugs are being tested in NCT01596647?

Interventions: caffeine, diclofenac, omeprazole, midazolam, TKI258.

What is the status of NCT01596647?

NCT01596647 is currently COMPLETED.

Last reviewed 2020-12-17 · How we verify

A Phase I, Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effect of TKI258 on the Pharmacokinetics of Caffeine, Diclofenac, Omeprazole and Midazolam Administered as a Four-drug Cocktail in Patients With Advanced Solid Tumors, Excluding Breast Cancer

NCT01596647 Phase 1 COMPLETED

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.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	COMPLETED
Enrolment	39
Start date	2012-05
Completion	2014-07

Conditions

Advanced Solid Tumors, Excluding Breast Cancer

Interventions

caffeine
diclofenac
omeprazole
midazolam
TKI258

Primary outcomes

Probe substrate pharmacokinetics (PK) parameters: Cmax (Maximum (peak) concentration of drug) — multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),
Probe substrate PK parameters: AUCtlast (Area Under the Curve) — multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),
Probe substrate PK parameters: AUCinf — multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),
Probe substrate PK parameters:Tmax (Time to maximum concentration) — multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),
Probe substrate PK parameters: HL (Half-life time) — multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),
Probe substrate PK parameters:CL/F (Apparent Oral Clearance) — multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),

Countries

United States