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
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.
Arms & interventions
- Drugdabrafenib
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
- Drugtrametinib
trametinib is available in tablets (0.5mg, 2mg dose)
Outcome measures
Primary
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.
Time frame: 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
Clinical Benefit Assessment by investigator
Time frame: 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
Study locations (5)
Honor Health Research Institute
Scottsdale, Arizona, 85258
Honor Health Research Institute
Scottsdale, Arizona, 85258
National Institute Of Health
Bethesda, Maryland, 20892
James Cancer Hospital and Solove Research Institute Ohio State
Columbus, Ohio, 43210
Mary Crowley Cancer Research
Dallas, Texas, 75251