All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Non Small Cell Lung Cancer
High Grade Glioma
Jun 22, 2020
Dec 28, 2017
Jul 17, 2023
18 Years - 100 Years (Adult, Older Adult)
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
trametinib is available in tablets (0.5mg, 2mg dose)
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.
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.
Honor Health Research Institute
James Cancer Hospital and Solove Research Institute Ohio State