RecruitingPhase 4NCT03340506

Dabrafenib and/or Trametinib Rollover Study

Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study


Sponsor

Novartis Pharmaceuticals

Enrollment

100 participants

Start Date

Dec 28, 2017

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This is a rollover study allowing patients who have been receiving dabrafenib and/or trametinib — targeted drugs that block mutations in the BRAF gene that drive certain cancers — in a Novartis or GSK-sponsored clinical trial to continue receiving the same treatment after that trial ends. **You may be eligible if...** - You are currently receiving dabrafenib and/or trametinib as part of a Novartis or former GSK clinical trial that has completed its main objectives - Your doctor believes you are still benefiting from the treatment **You may NOT be eligible if...** - You were permanently removed from your previous trial due to a serious problem with the drug - Your doctor does not believe continued treatment is appropriate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGdabrafenib

dabrafenib is available in capsules (50mg and 75mg) taken twice a day

DRUGtrametinib

trametinib is available in tablets (0.5mg, 2mg dose)


Locations(28)

Honor Health Research Institute

Scottsdale, Arizona, United States

Honor Health Research Institute

Scottsdale, Arizona, United States

National Institute Of Health

Bethesda, Maryland, United States

James Cancer Hospital and Solove Research Institute Ohio State

Columbus, Ohio, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Innsbruck, Tyrol, Austria

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Copenhagen, Denmark

Novartis Investigative Site

Lyon, France

Novartis Investigative Site

Nantes, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Villejuif, France

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Heidelberg, Germany

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Novartis Investigative Site

Rotterdam, South Holland, Netherlands

Novartis Investigative Site

Utrecht, Netherlands

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Songkhla, Hat Yai, Thailand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03340506


Related Trials