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

NCT ID: NCT01596647

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors, Excluding Breast Cancer

Keywords

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cancer, tumors, phase I, drug-drug interaction, pharmacokinetic, probe drug, caffeine, diclofenac, omeprazole, midazolam, CYP1A2, CYP2C9, CYP2C19, CYP3A4

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TKI258 (dovitinib)

dovitinib, 5 days on / 2 days off dose schedule

Group Type EXPERIMENTAL

caffeine

Intervention Type DRUG

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

diclofenac

Intervention Type DRUG

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

omeprazole

Intervention Type DRUG

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

midazolam

Intervention Type DRUG

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

TKI258

Intervention Type DRUG

dovitinib, 5 days on / 2 days off dose schedule

Interventions

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caffeine

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

Intervention Type DRUG

diclofenac

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

Intervention Type DRUG

omeprazole

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

Intervention Type DRUG

midazolam

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

Intervention Type DRUG

TKI258

dovitinib, 5 days on / 2 days off dose schedule

Intervention Type DRUG

Other Intervention Names

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probe drug probe drug probe drug probe drug dovitinib

Eligibility Criteria

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Inclusion Criteria

* Patients with a cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer which has progressed despite standard therapy or for which no standard therapy exists
* ECOG performance status 0 or 1 and anticipated life expectancy ≥ 3 months
* Patient must meet protocol-specific laboratory values

Exclusion Criteria

* Patients with brain metastases
* Patients who have received or who are expected to receive any prohibited medications and therapies
* Patients who have received CYP1A2 inducer, CYP2C9/2C19 inducer or CYP3A4 inducer medications within 30 days prior to start study treatment or are expected to receive during the first 14 days after starting the study treatment
* Patients with a known hypersensitivity to benzodiazepines
* Patients who have not recovered from previous anti-cancer therapies
* Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of TKI258
* Patients who have concurrent severe and/or uncontrolled concomitant medical conditions that could compromise participation in the study
* Female patients who are pregnant or breast-feeding
* Fertile males or women not willing to use highly effective methods of contraception
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of Kansas Cancer Center Medical Center

Kansas City, Kansas, United States

Site Status

Henry Ford Hospital Henry Ford

Detroit, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Comprehensive Cancer Centers

Las Vegas, Nevada, United States

Site Status

Cancer Institute of New Jersey Dept of Cancer Institute of NJ

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13883

Results for CTKI258A2119 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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2011-001489-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CTKI258A2119

Identifier Type: -

Identifier Source: org_study_id