Dabrafenib and/or Trametinib Rollover Study
Recruiting · NCT03340506 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
33 locations listed across 4 US 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 - Augsburg, Germany
- Novartis Investigative Site - Barcelona, Spain
- Novartis Investigative Site - Beijing, China
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Budapest, Hungary
- Novartis Investigative Site - Copenhagen, Denmark
- Novartis Investigative Site - Essen, Germany
- Novartis Investigative Site - Hamburg, Germany
- Novartis Investigative Site - Hamburg, Germany
- Novartis Investigative Site - Heidelberg, Germany
- Novartis Investigative Site - Lyon, France
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Nantes, France
- Novartis Investigative Site - Paris, France
- Novartis Investigative Site - Paris, France
- Novartis Investigative Site - Utrecht, Netherlands
- Novartis Investigative Site - Valencia, Spain
- Novartis Investigative Site - Villejuif, France
- Novartis Investigative Site - Mannheim, Baden-Wurttemberg, Germany
- Novartis Investigative Site - Caba, Buenos Aires, Argentina
- Novartis Investigative Site - Kashiwa, Chiba, Japan
- Novartis Investigative Site - Debrecen, Hajdu Bihar Megye, Hungary
- Novartis Investigative Site - Songkhla, Hat Yai, Thailand
- Novartis Investigative Site - Rotterdam, South Holland, Netherlands
- Novartis Investigative Site - Chuo Ku, Tokyo, Japan
- Novartis Investigative Site - Innsbruck, Tyrol, Austria