Dabrafenib and/or Trametinib Rollover Study

Recruiting now · Phase 4

Conditions studied: Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers, High Grade Glioma

In brief

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.

Key facts

Study ID

NCT03340506

Run by

Novartis Pharmaceuticals

People needed

100

Starts

2018-01-26

Expected to finish

2032-12-28

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Essen, Germany (enrolling)
• Novartis Investigative Site — Barcelona, Spain (enrolling)
• Novartis Investigative Site — Madrid, Spain (enrolling)
• Novartis Investigative Site — Madrid, Spain (enrolling)
• Novartis Investigative Site — Paris, France (enrolling)
• Novartis Investigative Site — Madrid, Spain (enrolling)
• Novartis Investigative Site — Valencia, Spain (enrolling)
• Novartis Investigative Site — Hamburg, Germany (enrolling)
• 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 — Madrid, Spain
• Honor Health Research Institute — Scottsdale, Arizona, United States
• Novartis Investigative Site — Songkhla, Hat Yai, Thailand

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.