Study of efficacy and safety of dabrafenib in combination with trametinib in pediatric patients with BRAF V600 mutation positive LGG or relapsed or refractory HGG tumors

Phase 2

Completed

• Conditions: Glioma

• Registration Number: JPRN-jRCT2080223938
• Lead Sponsor: ovartis Pharma. K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 18

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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified