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

Official Title

Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)

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.

Trial Description

Primary Outcome:

• HGG cohort: Overall response rate (ORR)
• LGG cohort: Overall response rate (ORR)

• HGG cohort: Overall response rate (ORR)
• HGG and LGG cohorts: Duration of response (DOR)
• HGG and LGG cohorts: Time to response (TTR)
• HGG and LGG cohorts: Overall survival (OS)
• HGG and LGG cohorts: Progression free survival (PFS)
• Patients on DRB+TMT: Area under the curve (AUClast)
• Patients on DRB+TMT: Area under the curve (AUCtau)
• Patients on DRB+TMT: Maximum Plasma Concentration (Cmax)
• Patients on DRB+TMT: Time to reach maximum concentration (Tmax)
• Patients on DRB+TMT: Elimination half-life (T1/2)
• Patients on DRB+TMT: Predose plasma concentration (Ctrough)
• HGG and LGG cohorts: Adverse events
• HGG and LGG cohorts: Vital signs
• HGG and LGG cohorts: Abnormal lab values
• HGG and LGG cohorts: Changes in Electrocardiogram (ECG)
• HGG and LGG cohorts: ECHO
• LGG cohort: Overall response rate (ORR)
• HGG and LGG cohort: Palatability of pediatric formulations
• LGG cohort: PROMIS Parent Proxy scale
• HGG and LGG Cohorts: Clinical benefit rate (CBR)
• LGG cohort: 2 year Overall survival (OS)

View this trial on ClinicalTrials.gov