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Dabrafenib and/or Trametinib Rollover Study
Sponsor: Novartis Pharmaceuticals
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2017-12-28
Completion Date
2032-12-28
Last Updated
2026-04-01
Healthy Volunteers
No
Interventions
dabrafenib
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
trametinib
trametinib is available in tablets (0.5mg, 2mg dose)
Locations (28)
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
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
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Songkhla, Hat Yai, Thailand