Glioma
Conditions
Interventions
Dabrafenib (DRB436) will be administered orally, twice daily based on weight, age and the
appropriate dose level.
Trametinib (TMT212) will be administered orally, once daily in combination with the f
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - HGG cohort: Relapsed, progressed, or failed to respond to frontline therapy. - LGG cohort: Patients with progressive disease following surgical excision, or non-surgical candidates with necessity to begin systemic treatment because of a risk of neurological impairment with progression. - Patients with measurable disease.
Exclusion criteria
Exclusion criteria: - Previous treatment with dabrafenib or another RAF inhibitor, trametinib or another MEK inhibitor, or an ERK inhibitor. - HGG patients: Cancer therapy or investigational drugs within 3 weeks preceding the first dose of study treatment. - LGG patients: Any systemic anticancer therapy (chemotherapy, immunotherapy, biologic therapy or vaccine therapy) or investigational drugs prior to enrollment. - history of allergic reactions or contraindications to the use of carboplatin or vincristine. - Autologous or allogeneic stem cell transplant within 3 months prior to the first dose of study treatment. - History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study. - Women who are pregnant or actively breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HGG cohort: ORR, proportion of patients with a best overall confirmed Complete Response (CR) or Partial Response (PR) by independent assessment per RANO criteria. LGG cohort: ORR, proportion of patients with a best overall confirmed Complete Response (CR) or Partial Response (PR) by blinded independent review per RANO criteria. | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactTakamitsu Hirano
Novartis Pharma. K.K.
Outcome results
None listed