Phase II Pediatric Study With Dabrafenib in Combination With Trametinib in Patients With HGG and LGG

• Status: Active, not recruiting
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma or relapsed or refractory high grade glioma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Carboplatin; Dabrafenib; Trametinib; Vincristine

Criteria

Inclusion Criteria:

• Diagnosis of BRAF V600 mutant High Grade glioma that has relapsed, progressed or failed to respond to frontline therapy

• Diagnosis of BRAF V600 mutant Low Grade glioma with progressive disease following surgical excision, or non-surgical candidates with necessity to begin first systemic treatment because of a risk of neurological impairment with progression.

• Confirmed measurable disease

Exclusion Criteria:

• Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK inhibitor

• HGG patient: Cancer treatment within the past 3 weeks. LGG patient: Any systemic therapy or radiotherapy prior to enrollment

• LGG patients: history of allergic reaction or contraindications to the use of carboplatin or vincristine

• Stem cell transplant within the past 3 months

• History of heart disease

• Pregnant or lactating females

Other protocol-defined Inclusion/exclusion may apply.