Dabrafenib and/or Trametinib Rollover Study

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.

Interventions

• dabrafenib · DRUG

  dabrafenib is available in capsules (50mg and 75mg) taken twice a day

• trametinib · DRUG

  trametinib is available in tablets (0.5mg, 2mg dose)

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (33)

• Honor Health Research Institute, Scottsdale, Arizona · ACTIVE_NOT_RECRUITING
• National Institute Of Health, Bethesda, Maryland · ACTIVE_NOT_RECRUITING
• James Cancer Hospital and Solove Research Institute Ohio State, Columbus, Ohio · COMPLETED
• Mary Crowley Cancer Research, Dallas, Texas · COMPLETED
• Novartis Investigative Site, Caba, Buenos Aires, Argentina · COMPLETED
• Novartis Investigative Site, Innsbruck, Tyrol, Austria · ACTIVE_NOT_RECRUITING
• Novartis Investigative Site, Beijing, China · COMPLETED
• Novartis Investigative Site, Copenhagen, Denmark · ACTIVE_NOT_RECRUITING
• Novartis Investigative Site, Lyon, France · ACTIVE_NOT_RECRUITING
• Novartis Investigative Site, Nantes, France · ACTIVE_NOT_RECRUITING
• Novartis Investigative Site, Paris, France · RECRUITING
• Novartis Investigative Site, Paris, France · COMPLETED
• Novartis Investigative Site, Villejuif, France · RECRUITING
• Novartis Investigative Site, Mannheim, Baden-Wurttemberg, Germany · COMPLETED
• Novartis Investigative Site, Augsburg, Germany · ACTIVE_NOT_RECRUITING
• Novartis Investigative Site, Berlin, Germany · COMPLETED
• Novartis Investigative Site, Essen, Germany · RECRUITING
• Novartis Investigative Site, Hamburg, Germany · COMPLETED
• Novartis Investigative Site, Hamburg, Germany · RECRUITING
• Novartis Investigative Site, Heidelberg, Germany · ACTIVE_NOT_RECRUITING
• Novartis Investigative Site, Debrecen, Hajdu Bihar Megye, Hungary · COMPLETED
• Novartis Investigative Site, Budapest, Hungary · COMPLETED
• Novartis Investigative Site, Kashiwa, Chiba, Japan · COMPLETED
• Novartis Investigative Site, Chuo Ku, Tokyo, Japan · COMPLETED
• Novartis Investigative Site, Rotterdam, South Holland, Netherlands · COMPLETED
• Novartis Investigative Site, Utrecht, Netherlands · ACTIVE_NOT_RECRUITING
• Novartis Investigative Site, Barcelona, Spain · RECRUITING
• Novartis Investigative Site, Madrid, Spain · RECRUITING
• Novartis Investigative Site, Madrid, Spain · RECRUITING
• Novartis Investigative Site, Madrid, Spain · COMPLETED
• Novartis Investigative Site, Madrid, Spain · RECRUITING
• Novartis Investigative Site, Valencia, Spain · ACTIVE_NOT_RECRUITING
• Novartis Investigative Site, Songkhla, Hat Yai, Thailand · ACTIVE_NOT_RECRUITING