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Closed (no longer recruiting)Last updated: 1 February 2024

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 gliomaPhase 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)

Clinical summary

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.

Conditions

This trial is treating patients with glioma.

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People1 - 17

Phase

II

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

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)

Eligibility

Inclusion

  • Diagnosis of BRAF V600 mutant High Grade glioma that had relapsed, progressed or failed to respond to frontline therapy
  • Diagnosis of BRAF V600 mutant Low Grade glioma with progressive disease following surgical excision, or non-surgical candidates with necessity to begin first systemic treatment because of a risk of neurological impairment with progression.
  • Confirmed measurable disease

Exclusion

  • Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK inhibitor
  • HGG patient: Cancer treatment within the past 3 weeks. LGG patient: Any systemic therapy or radiotherapy prior to enrollment
  • LGG patients: history of allergic reaction or contraindications to the use of carboplatin or vincristine
  • Stem cell transplant within the past 3 months
  • History of heart disease
  • Pregnant or lactating females

Inclusion

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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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