RECRUITING Phase 4 ClinicalTrials.gov

Dabrafenib and/or Trametinib Rollover Study

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT03340506

Registry updated: 2026-10-20

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Description

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.

Interventions

dabrafenib (Drug)
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
trametinib (Drug)
trametinib is available in tablets (0.5mg, 2mg dose)

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.

Conditions

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

Locations

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 — Toronto, Ontario, Canada
Novartis Investigative Site — Beijing, China
Novartis Investigative Site — Brno, Czechia
Novartis Investigative Site — Prague, Czechia
Novartis Investigative Site — Copenhagen, Denmark
Novartis Investigative Site — Lyon, France
Novartis Investigative Site — Nantes, France
Novartis Investigative Site — Paris, France
Novartis Investigative Site — Paris, France
Novartis Investigative Site — Villejuif, France
Novartis Investigative Site — Mannheim, Baden-Wurttemberg, Germany
Novartis Investigative Site — Augsburg, Germany
Novartis Investigative Site — Berlin, Germany
Novartis Investigative Site — Essen, Germany
Novartis Investigative Site — Hamburg, 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 — Madrid, Spain
Novartis Investigative Site — Madrid, Spain
Novartis Investigative Site — Valencia, Spain
Novartis Investigative Site — Songkhla, Hat Yai, Thailand

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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