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 ]

ORR as determined by local assessment based on Magnetic resonance imaging MRI) or CT (CAT) scans using Response Assessment in Neuro-Oncology Criteria (RANO) criteria.


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