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Phase II Pediatric Study With Dabrafenib in Combination With Trametinib in Patients With HGG

Descriptive Information
Brief Title † Phase II Pediatric Study With Dabrafenib in Combination With Trametinib in Patients With HGG
Official 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 Relapsed or Refractory High Grade Glioma (HGG)
Brief Summary 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 relapsed or refractory high grade glioma.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Overall response rate (ORR)
Secondary Outcome Measure † Overall response rate (ORR)
Condition † Anaplastic Astrocytoma Glioblastoma Giant Cell Glioblastoma Gliosarcoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Anaplastic Ependymoma Choroid Plexus Carcinoma Anaplastic Ganglioglioma Pineal Parenchymal Tumor Pineoblastoma Medulloblastoma PNET Rhabdoid Tumor Perineurioma MPNST Malignant Meningloma Anaplastic Hemangiopericytoma
Intervention † Drugdabrafenib
Study Arms / Comparison Groups dabrafenib and trametinib Patient dose based on weight and age. Patients will receive study drug until they are no longer receiving clinical benefit as determined by investigator, disease progression, death, unacceptable toxicity, start of new anticancer treatment or study is terminated by Sponsor.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 40
Start Date † July 17, 2017
Completion Date April 13, 2022
Primary Completion Date April 15, 2021
Eligibility Criteria † Inclusion Criteria: - Diagnosis of High Grade glioma - Relapsed, progressed or failed to respond to frontline therapy. - Able to swallow capsules Exclusion Criteria: - Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK inhibitor - Cancer treatment within the past 3 weeks - Stem cell transplant within the past 3 months - History of heart disease - Pregnant or lactating females
Gender All
Ages 6 Years - 17 Years
Accepts Healthy Volunteers No
Contacts †† Novartis Pharmaceuticals, 1-888-669-6682, novartis.email@novartis.com
Location Countries †
Administrative Information
NCT ID † NCT02684058
Organization ID CDRB436G2201
Secondary IDs †† 2015-004015-20
Responsible Party Sponsor
Study Sponsor † Novartis Pharmaceuticals
Collaborators ††
Investigators † Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Information Provided By
Verification Date June 2017
First Received Date † February 4, 2016
Last Updated Date June 13, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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