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Dabrafenib and/or Trametinib Rollover Study
Dabrafenib and/or Trametinib Rollover Study

NCT03340506

RecruitingPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers, High Grade Glioma

Interventions: dabrafenib, trametinib

Countries: United States, Argentina, Austria, China, Denmark, France, Germany, Hungary

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (32)
  • Scottsdale, Arizona, United States
  • Bethesda, Maryland, United States
  • Columbus, Ohio, United States
  • Dallas, Texas, United States
  • Caba, Buenos Aires, Argentina
  • Innsbruck, Tyrol, Austria
  • Beijing, China
  • Copenhagen, Denmark
  • Lyon, France
  • Nantes, France
  • Paris, France
  • Paris, France
  • Villejuif, France
  • Mannheim, Baden-Wurttemberg, Germany
  • Berlin, Germany
  • Essen, Germany
  • Hamburg, Germany
  • Hamburg, Germany
  • Heidelberg, Germany
  • Debrecen, Hajdu Bihar Megye, Hungary
  • Budapest, Hungary
  • Kashiwa, Chiba, Japan
  • Chuo Ku, Tokyo, Japan
  • Rotterdam, South Holland, Netherlands
  • Utrecht, Netherlands
  • Barcelona, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Madrid, Spain
  • + 2 more on CT.gov