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NCT03340506PHASE4Recruiting

Dabrafenib and/or Trametinib Rollover Study

Novartis Pharmaceuticals

Start Date

1/26/2018

Completion Date

12/28/2032

Summary

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

Eligibility Criteria

Age Range: 18 years to 100 years

Inclusion Criteria: * Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective. * In the opinion of the Investigator would benefit from continued treatment. Exclusion Criteria: * Patient has been previously permanently discontinued from study treatment in the parent protocol. * Patient's indication is commercially available and reimbursed in the local country. * Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.

Interventions

DRUG

dabrafenib

DRUG

trametinib

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Conditions

MelanomaNon Small Cell Lung CancerSolid TumorRare CancersHigh Grade Glioma

Locations

Honor Health Research Institute

Scottsdale, Arizona 85258

United States

National Institute Of Health

Bethesda, Maryland 20892

United States

James Cancer Hospital and Solove Research Institute Ohio State

Columbus, Ohio 43210

United States

Mary Crowley Cancer Research

Dallas, Texas 75251

United States

Novartis Investigative Site

Caba, Buenos Aires C1121ABE

Argentina

Novartis Investigative Site

Innsbruck, Tyrol 6020

Austria

Novartis Investigative Site

Beijing, 100036

China

Novartis Investigative Site

Copenhagen, DK-2100

Denmark

Novartis Investigative Site

Lyon, 69373

France

Novartis Investigative Site

Nantes, 44093

France

Novartis Investigative Site

Paris, 75231

France

Novartis Investigative Site

Paris, 75970

France

Novartis Investigative Site

Villejuif, 94800

France

Novartis Investigative Site

Mannheim, Baden-Wurttemberg 68305

Germany

Novartis Investigative Site

Berlin, 13353

Germany

Novartis Investigative Site

Essen, 45147

Germany

Novartis Investigative Site

Hamburg, 20246

Germany

Novartis Investigative Site

Hamburg, 20246

Germany

Novartis Investigative Site

Heidelberg, 69120

Germany

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye 4032

Hungary

Novartis Investigative Site

Budapest, H 1122

Hungary

Novartis Investigative Site

Kashiwa, Chiba 277-8577

Japan

Novartis Investigative Site

Chuo Ku, Tokyo 1040045

Japan

Novartis Investigative Site

Rotterdam, South Holland 3015 GD

Netherlands

Novartis Investigative Site

Utrecht, 3584 CX

Netherlands

Novartis Investigative Site

Barcelona, 08035

Spain

Novartis Investigative Site

Madrid, 28009

Spain

Novartis Investigative Site

Madrid, 28040

Spain

Novartis Investigative Site

Madrid, 28041

Spain

Novartis Investigative Site

Madrid, 28050

Spain

Novartis Investigative Site

Valencia, 46026

Spain

Novartis Investigative Site

Songkhla, Hat Yai 90110

Thailand