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Dabrafenib and/or Trametinib Rollover Study
NCT03340506 · Novartis
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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.
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.
Study design
Enrollment target: 100 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2017-12-28
Estimated completion: 2032-12-28
Last updated: 2026-04-01
Interventions
Drug: dabrafenibDrug: trametinib
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.)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · +41613241111
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (28)
Honor Health Research InstituteRecruiting
Scottsdale, Arizona, United States
Honor Health Research InstituteRecruiting
Scottsdale, Arizona, United States
National Institute Of HealthActive Not Recruiting
Bethesda, Maryland, United States
James Cancer Hospital and Solove Research Institute Ohio StateCompleted
Columbus, Ohio, United States
Mary Crowley Cancer ResearchCompleted
Dallas, Texas, United States
Novartis Investigative SiteCompleted
Caba, Buenos Aires, Argentina
Novartis Investigative SiteActive Not Recruiting
Innsbruck, Tyrol, Austria
Novartis Investigative SiteCompleted
Beijing, China
Novartis Investigative SiteActive Not Recruiting
Copenhagen, Denmark
Novartis Investigative SiteActive Not Recruiting
Lyon, France
Novartis Investigative SiteActive Not Recruiting
Nantes, France
Novartis Investigative SiteCompleted
Paris, France
Novartis Investigative SiteCompleted
Villejuif, France
Novartis Investigative SiteCompleted
Mannheim, Baden-Wurttemberg, Germany
Novartis Investigative SiteCompleted
Berlin, Germany
Novartis Investigative SiteCompleted
Hamburg, Germany
Novartis Investigative SiteActive Not Recruiting
Heidelberg, Germany
Novartis Investigative SiteCompleted
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative SiteCompleted
Budapest, Hungary
Novartis Investigative SiteCompleted
Kashiwa, Chiba, Japan
Novartis Investigative SiteCompleted
Chuo Ku, Tokyo, Japan
Novartis Investigative SiteCompleted
Rotterdam, South Holland, Netherlands
Novartis Investigative SiteActive Not Recruiting
Utrecht, Netherlands
Novartis Investigative SiteRecruiting
Barcelona, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteCompleted
Madrid, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteActive Not Recruiting
Songkhla, Hat Yai, Thailand