NCT03340506From ClinicalTrials.govRecruiting

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

Melanoma
Non Small Cell Lung Cancer
Solid Tumor
Rare Cancers
High Grade Glioma

At a glance

Phase: Phase 4
Study type: Interventional
Sponsor: Novartis Pharmaceuticals
Enrolment target: 100
Started: 26 January 2018
Main results due: 28 December 2032
Study sites: 35
Registry updated: 23 September 2026

Can you take part?

Ages 18 years to 100 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(35)

Honor Health Research Institute
Scottsdale, Arizona, United States
Active, not recruiting
National Institute Of Health
Bethesda, Maryland, United States
Active, not recruiting
James Cancer Hospital and Solove Research Institute Ohio State
Columbus, Ohio, United States
Completed
Mary Crowley Cancer Research
Dallas, Texas, United States
Completed
Novartis Investigative Site
Caba, Buenos Aires, Argentina
Completed
Novartis Investigative Site
Innsbruck, Tyrol, Austria
Active, not recruiting
Novartis Investigative Site
Toronto, Ontario, Canada
Recruiting
Novartis Investigative Site
Beijing, China
Completed
Novartis Investigative Site
Prague, Czechia
Recruiting
Novartis Investigative Site
Copenhagen, Denmark
Active, not recruiting
Novartis Investigative Site
Lyon, France
Active, not recruiting
Novartis Investigative Site
Nantes, France
Completed
Novartis Investigative Site
Paris, France
Recruiting
Novartis Investigative Site
Paris, France
Completed
Novartis Investigative Site
Villejuif, France
Recruiting
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, Germany
Completed
Novartis Investigative Site
Augsburg, Germany
Active, not recruiting
Novartis Investigative Site
Berlin, Germany
Completed
Novartis Investigative Site
Essen, Germany
Active, not recruiting
Novartis Investigative Site
Hamburg, Germany
Completed
Novartis Investigative Site
Hamburg, Germany
Active, not recruiting
Novartis Investigative Site
Heidelberg, Germany
Active, not recruiting
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary
Completed
Novartis Investigative Site
Budapest, Hungary
Completed
Novartis Investigative Site
Kashiwa, Chiba, Japan
Completed
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Completed
Novartis Investigative Site
Rotterdam, South Holland, Netherlands
Completed
Novartis Investigative Site
Utrecht, Netherlands
Active, not recruiting
Novartis Investigative Site
Barcelona, Spain
Recruiting
Novartis Investigative Site
Madrid, Spain
Recruiting
Novartis Investigative Site
Madrid, Spain
Recruiting
Novartis Investigative Site
Madrid, Spain
Completed
Novartis Investigative Site
Madrid, Spain
Recruiting
Novartis Investigative Site
Valencia, Spain
Active, not recruiting
Novartis Investigative Site
Songkhla, Hat Yai, Thailand
Active, not recruiting

Showing 35 of 35 sites. 8 of the 35 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT03340506. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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