Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Fluvoxamine

Anti-Anxiety Agents

Selective Serotonin Reuptake Inhibitors

Serotonin

Neurotransmitter Agents

Antidepressive Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

dovitinib, 5 days on / 2 days off dose schedule

dovitinib (TKI258)

fluvoxamine

Novartis Pharmaceuticals

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.

Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors.

A Phase I, Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effect of the CYP1A2 Inhibitor, Fluvoxamine, on Dovitinib (TKI258) Pharmacokinetics in Patients With Advanced Solid Tumors

overall response based on investigator assessment and best overall response using RECIST 1.1

Breast Diseases

Skin Diseases

Central Nervous System Stimulants

Adjuvants, Anesthesia

Gastrointestinal Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Other Dietary Supplements

Caffeine

Midazolam

Omeprazole

Diclofenac

Anesthetics

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Phosphodiesterase Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam

caffeine

diclofenac

omeprazole

midazolam

TKI258

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.

Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors

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

overall response based on investigator's assessment and best overall response using RECIST 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors.	NCT01700270	Advanced Solid ...	dovitinib (TKI2... fluvoxamine	18 Years -	Novartis
Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors	NCT01596647	Advanced Solid ...	caffeine diclofenac omeprazole midazolam TKI258	18 Years -	Novartis

Spots Global Cancer Trial Database for advanced solid tumors, excluding breast cancer