Dabrafenib and/or Trametinib Rollover Study

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03340506

Patient View

This rollover study provides continued access to dabrafenib and/or trametinib for patients who have completed a Novartis or former GSK-sponsored study and are deemed by investigators to benefit from ongoing treatment. Eligibility requires current treatment with these drugs. Dabrafenib is administered in 50mg or 75mg capsules twice daily, while trametinib is available in 0.5mg or 2mg tablets.

Patient Parameters

Program Overview

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.

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