NCT02684058 : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

1-17Age 1-17

Brain and Spinal<br/>CancersCancer LocationBrain and Spinal
Cancers

Systemic therapy | Brain and spinal cordAstrocytoma,Glioblastoma (GBM) ,Glioma

Trial Overview Read MoreRead more

This phase II trial is investigating the activity of two oral drugs (dabrafenib and trametinib) in children and adolescents who have BRAF V600 mutation positive low grade glioma or relapsed or refractory high grade glioma.
 

This trial is treating patients with glioma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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)

Commercial Sponsor

Novartis Pharmaceuticals

Summary

This is a non-randomised trial. Participants will be allocated to one of three cohorts. In the HGG cohort, all patients will receive dabrafenib (DRB) and trametinib (TMT) oral, twice daily. In the LGG cohorts patients will be randomised 2:1 to either DRB+TMT or active chemotherapy.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Ms Allison Lamb
allison.lamb@rch.org.au
(03) 9345 4989

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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