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

NCT ID: NCT01700270

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors, Excluding Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dovitinib (TKI258)

dovitinib, 5 days on / 2 days off dose schedule

Group Type EXPERIMENTAL

dovitinib (TKI258)

Intervention Type DRUG

fluvoxamine

Intervention Type DRUG

perpetrator drug; 7 days of dosing

Interventions

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dovitinib (TKI258)

Intervention Type DRUG

fluvoxamine

perpetrator drug; 7 days of dosing

Intervention Type DRUG

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 an anticipated life expectancy of ≥3 months- Patient must meet protocol-specific laboratory values
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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Montefiore Medical Center Montefiore Medical Center (SC)

The Bronx, New York, United States

Site Status

Cancer Therapy & Research Center / UT Health Science Center SC

San Antonio, Texas, United States

Site Status

Novartis Investigative Site

Copenhagen, , Denmark

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Chur, , Switzerland

Site Status

Novartis Investigative Site

Geneva, , Switzerland

Site Status

Countries

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United States Denmark Netherlands Switzerland

References

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de Weger VA, Goel S, von Moos R, Schellens JHM, Mach N, Tan E, Anand S, Scott JW, Lassen U. A drug-drug interaction study to assess the effect of the CYP1A2 inhibitor fluvoxamine on the pharmacokinetics of dovitinib (TKI258) in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2018 Jan;81(1):73-80. doi: 10.1007/s00280-017-3469-4. Epub 2017 Nov 3.

Reference Type DERIVED
PMID: 29101463 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13925

Results for CTKI258A2120 on the Novartis Clinical Trial Website

Other Identifiers

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2012-001546-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CTKI258A2120

Identifier Type: -

Identifier Source: org_study_id