Dabrafenib and/or Trametinib Rollover Study
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
| Condition(s) | Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers, High Grade Glioma |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Lead sponsor | Novartis Pharmaceuticals |
| Locations | Scottsdale, Arizona, United States; Scottsdale, Arizona, United States; Bethesda, Maryland, United States; Columbus, Ohio, United States; Dallas, Texas, United States; Caba, Buenos Aires, Argentina (+23 more sites) |
| Start date | 2017-12-28 |
| NCT ID | NCT03340506 |
| Official listing | https://clinicaltrials.gov/study/NCT03340506 |