Phase II Pediatric Study With Dabrafenib in Combination With Trametinib in Patients With HGG and LGG
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)
ClinicalTrials.gov Identifier: NCT02684058
Novartis Reference Number: CDRB436G2201
Last Update: Oct 19, 2020
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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.
Interventions
Eligibility Criteria
Inclusion Criteria:
Diagnosis of BRAF V600 mutant High Grade glioma that has 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 Criteria:
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
Other protocol-defined Inclusion/exclusion may apply.
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]