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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
trametinib is available in tablets (0.5mg, 2mg dose)
Honor Health Research Institute
Scottsdale, Arizona, United States
RECRUITINGHonor Health Research Institute
Scottsdale, Arizona, United States
RECRUITINGNational Institute Of Health
Bethesda, Maryland, United States
RECRUITINGJames Cancer Hospital and Solove Research Institute Ohio State
Columbus, Ohio, United States
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.
Clinical Benefit Assessment by investigator
To evaluate clinical benefit as assessed by the 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mary Crowley Cancer Research
Dallas, Texas, United States
COMPLETEDNovartis Investigative Site
Caba, Buenos Aires, Argentina
COMPLETEDNovartis Investigative Site
Innsbruck, Tyrol, Austria
ACTIVE_NOT_RECRUITINGNovartis Investigative Site
Beijing, China
COMPLETEDNovartis Investigative Site
Copenhagen, Denmark
ACTIVE_NOT_RECRUITINGNovartis Investigative Site
Lyon, France
ACTIVE_NOT_RECRUITING...and 18 more locations