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)
Who is this study for? Patients with Glioma
Status: Completed
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study was to investigate the activity 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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Children's Hospital of Orange County
Orange
Washington, D.c.
Childrens National Hospital
Washington
Florida
Nicklaus Childrens Hospital
Miami
Illinois
Ann and Robert H Lurie Childrens Hospital of Chicago .
Chicago
Indiana
Indiana University School of Medicine .
Indianapolis
Maryland
Johns Hopkins University IDS Pharmacy John Hopkins Hospital
Baltimore
Missouri
Washington University School of Medicine SC
Saint Louis
Ohio
Cincinnati Childrens Hospital Medical Center Cancer & Blood Disease Inst.
Cincinnati
Tennessee
St Jude Children's Research Hospital
Memphis
Texas
Texas Children s Hospital Baylor College of Medicine
Houston
Other Locations
Argentina
Novartis Investigative Site
Caba
Australia
Novartis Investigative Site
Parkville
Novartis Investigative Site
Randwick
Belgium
Novartis Investigative Site
Brussels
Brazil
Novartis Investigative Site
Barretos
Novartis Investigative Site
Sao Paulo
Novartis Investigative Site
Sao Paulo
Canada
Novartis Investigative Site
Montreal
Novartis Investigative Site
Toronto
Novartis Investigative Site
Vancouver
Denmark
Novartis Investigative Site
Copenhagen
Finland
Novartis Investigative Site
Tampere
France
Novartis Investigative Site
Lille Cedex
Novartis Investigative Site
Lyon
Novartis Investigative Site
Paris
Novartis Investigative Site
Strasbourg
Novartis Investigative Site
Toulouse Cedex
Novartis Investigative Site
Villejuif
Germany
Novartis Investigative Site
Augsburg
Novartis Investigative Site
Berlin
Novartis Investigative Site
Essen
Novartis Investigative Site
Gottingen
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Koeln
Israel
Novartis Investigative Site
Petach-tikva
Novartis Investigative Site
Tel-hashomer
Italy
Novartis Investigative Site
Firenze
Novartis Investigative Site
Genova
Novartis Investigative Site
Milano
Novartis Investigative Site
Roma
Novartis Investigative Site
Torino
Japan
Novartis Investigative Site
Fukuoka City
Novartis Investigative Site
Osaka
Novartis Investigative Site
Setagaya-ku
Netherlands
Novartis Investigative Site
Utrecht
Russian Federation
Novartis Investigative Site
Moscow
Spain
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Madrid
Novartis Investigative Site
Valencia
Sweden
Novartis Investigative Site
Stockholm
Switzerland
Novartis Investigative Site
Zuerich
United Kingdom
Novartis Investigative Site
Leeds
Novartis Investigative Site
Liverpool
Novartis Investigative Site
London
Time Frame
Start Date: 2017-12-28
Completion Date: 2023-04-28
Participants
Target number of participants: 151
Treatments
Experimental: LGG cohort: dabrafenib and trametinib
Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
Active_comparator: LGG cohort: carboplatin and vincristine
Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy.
Experimental: HGG cohort: dabrafenib and trametinib
Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
Authors
Theodore Laetsch, Patricia A Baxter, Chenue Abongwa, Kenneth Cohen, Mark W. Kieran, Kevin Ginn, Alberto Broniscer, Lindsey Hoffman, Ziad Khatib, Cynthia J. Wetmore, Roger Packer, Ashley Plant, Stewart Goldman, Lindsay Kilburn, Stephen Gilheeney, Eric Sandler, Trent Hummel, Kathleen Dorris, Santhosh Upadhyaya
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals