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

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 100 participants

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)

Primary Outcomes

• Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination (Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.)

Secondary Outcomes

• Clinical Benefit Assessment by investigator (Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.)

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.

Trial Locations

• 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
• ...and 10 more locations

More Melanoma Trials

View all Melanoma clinical trials