High Grade Glioma, Melanoma, Non Small Cell Lung Cancer, Rare Cancers, Solid Tumor
Conditions
Keywords
Tafinlar, Mekinist, Dabrafenib, Trametinib, Adult, Melanoma, Melanoma Stage IV, Metastatic Melanoma, Advanced Melanoma, Lung Cancer, NSLC, Non Small Cell Lung Cancer, BRAF V600 Mutation, BRAF Gene Mutation, Solid tumor, Rare cancers, High Grade Glioma
Brief 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
DRUGdabrafenib
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
DRUGtrametinib
trametinib is available in tablets (0.5mg, 2mg dose)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination | Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first. | Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Benefit Assessment by investigator | Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first. | To evaluate clinical benefit as assessed by the Investigator |
Countries
Argentina, Austria, Canada, China, Denmark, France, Germany, Hungary, Japan, Netherlands, Spain, Thailand, United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed