Last Update: Aug 25, 2026 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 ClinicalTrials.gov Identifier: [NCT03340506](https://clinicaltrials.gov/ct2/show/NCT03340506) Novartis Reference Number:CDRB436X2X02B [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study 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. Condition Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers, High Grade Glioma Phase Phase4 Overall Status Recruiting Number of Participants100 Start Date Jan 26, 2018 Completion Date Dec 28, 2032 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## Interventions Drug ### dabrafenib dabrafenib is available in capsules (50mg and 75mg) taken twice a day Drug ### trametinib 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. France #### Novartis Investigative Site Recruiting Paris,75231,France #### Novartis Investigative Site Recruiting Villejuif,94800,France Germany #### Novartis Investigative Site Recruiting Hamburg,20246,Germany #### Novartis Investigative Site Recruiting Essen,45147,Germany Spain #### Novartis Investigative Site Recruiting Madrid,28040,Spain #### Novartis Investigative Site Recruiting Madrid,28050,Spain #### Novartis Investigative Site Recruiting Barcelona,08035,Spain #### Novartis Investigative Site Recruiting Madrid,28009,Spain ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: