Clinical Trial: Phase II Pediatric Study With Dabrafenib in HGG Patients
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib Treatment in Children and Adolescent Patients With BRAF V600 Mutation Positive Relapsed or Refractory High Grade Glioma (HGG)
Brief Summary: The purpose of this study is to investigate the activity of dabrafenib in children and adolescent patients with BRAF V600 mutation positive relapsed or refractory high grade glioma.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Overall response rate (ORR) [ Time Frame: Within the first 4 months of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall response rate (ORR) [ Time Frame: Within the first 4 months of treatment ]ORR as determined by central assessment based on Magnetic resonance imaging (MRI) or CT (CAT)scans using Response Assessment in Neuro-Oncology (RANO criteria)
- Duration of response (DOR) [ Time Frame: Within the first year of treatment ]DOR as determined by local and central assessment based on MRI or CT scans using RANO criteria
- Progression free survival (PFS) [ Time Frame: Within the first year of treatment ]PFS as determined by local and central assessment based on MRI or CT scans using RANO criteria
- Overall survival (OS) [ Time Frame: 2 years from last patient dosed ]OS as defined as the time from first dose to death due to any cause
- Overall response (OR) [ Time Frame: Within 4 months of treatment ]OR as determined by central assessment based on MRI or CT scans using RANO criteria in patients with centrally confirmed HGG, BRAF V600 mutation and measurable disease
- Duration of response (DOR) [ Time Frame: Within 4 months of treatment ]DOR as determined by central assessment based on MRI or CT scans using RANO criteria in patients with centrally confirmed HGG, BRAF V600 mutation and measurable disease
- Progression-free survival (PFS) [ Time Frame: Within 4 months of treatment ]PFS as determined by central assessment based on MRI or CT scans using RANO criteria in patients with centrally confirmed HGG, BRAF V600 mutation and measurable disease
- Overall survival (OS) [ Time Frame: Within 4 months of treatment ]OS as determined by central assessment based on MRI or CT scans using RANO criteria in patients with centrally confirmed HGG, BRAF V600 mutation
- Area under the curve (AUClast) [ Time Frame: Within the first month of treatment ]Assessed from time zero to the last measurable sampling time
- Area under the curve (AUCtau) [ Time Frame: Within the first month of treatment ]Calculated to the end of a dosing interval at steady state (12 hours)
- Maximum Plasma Concentration (Cmax) [ Time Frame: Within the first month of treatment ]The maximum (peak) observed plasma drug concentration after a single dose
- Time to reach maximum concentration (Tmax) [ Time Frame: Within the first month of treatment ]The time to reach maximum (peak) concentration of study drug after a single dose
- Elimination half-life (T1/2) [ Time Frame: Within the first month of treatment ]The elimination half-life associated with the terminal slope of a semi-log concentration-time curve
- Predose plasma concentration (Ctrough) [ Time Frame: Within the first month of treatment ]Measured concentration at the end of a dosing interval at steady state, taken directly before next study drug administration).
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: February 4, 2016
Date Started: July 17, 2017
Date Completion: April 13, 2022
Last Updated: May 9, 2017
Last Verified: May 2017