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

Trial ID: NCT03340506

Interventional - Phase 4 - Recruiting

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.

Conditions

• Melanoma
• Non Small Cell Lung Cancer
• Solid Tumor
• Rare Cancers
• High Grade Glioma

Interventions

• dabrafenib
• trametinib

Eligibility

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.

Sponsor

Novartis Pharmaceuticals

Source: ClinicalTrials.gov

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