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Brief Title: Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
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 Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)
Study ID: NCT02684058
Brief 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)
Detailed Description: This study combines two pediatric glioma cohorts (LGG and HGG cohorts) into a multi-center, open-label, Phase II study: * The LGG cohort is a multi-center, randomized, open-label part of this Phase II study conducted in children and adolescent patients with BRAF V600 mutation-positive LGG whose tumor was unresectable and who required first systemic treatment. Participants in the LGG cohort were randomized in a 2:1 ratio to either dabrafenib plus trametinib or carboplatin with vincristine. * The HGG cohort is a multi-center, single-arm, open-label part of this Phase II study conducted in children and adolescent patients with BRAF V600 mutation-positive, refractory or relapsed HGG tumors after having received at least one previous standard therapy. The duration of treatment for participants on dabrafenib plus trametinib in LGG and for all patients in the HGG cohort was continued until the loss of clinical benefit in the opinion of the Investigator, unacceptable toxicity, start of a new anti-neoplastic therapy, discontinuation at the discretion of the investigator or patient/legal guardian, lost to follow-up, death, study termination by the sponsor, or until disease progression. The duration of treatment for patients in the carboplatin with vincristine arm in LGG cohort was continued for the prescribed number of cycles, as tolerated or until unacceptable toxicity, start of a new anti-neoplastic therapy, discontinuation at the discretion of the investigator or patient/legal guardian, lost to follow-up, death, study is terminated by the sponsor or until disease progression. Participants randomized to the carboplatin with vincristine treatment arm were allowed to cross over to receive dabrafenib in combination with trametinib after centrally confirmed RANO-defined disease progression. Crossover was allowed during the treatment period or the post-treatment period. After discontinuation of study treatment, all participants (LGG and HGG cohorts) were followed for safety for at least 30 days after the last dose of study treatment. All participants who discontinued study treatment for reasons other than disease progression, death, loss to follow up, or withdrawal of consent moved into the post-treatment efficacy follow-up phase. Finally, all participants were followed for survival once they discontinued study treatment for at least 2 years after the last patient first study treatment (except if consent was withdrawn, death, or the patient was lost to follow-up or discontinued study)
Minimum Age: 12 Months
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Children's Hospital of Orange County, Orange, California, United States
Childrens National Hospital, Washington, District of Columbia, United States
Nicklaus Childrens Hospital, Miami, Florida, United States
Ann and Robert H Lurie Childrens Hospital of Chicago ., Chicago, Illinois, United States
Indiana University School of Medicine ., Indianapolis, Indiana, United States
Johns Hopkins University IDS Pharmacy John Hopkins Hospital, Baltimore, Maryland, United States
Washington University School of Medicine SC, Saint Louis, Missouri, United States
Cincinnati Childrens Hospital Medical Center Cancer & Blood Disease Inst., Cincinnati, Ohio, United States
St Jude Children's Research Hospital, Memphis, Tennessee, United States
Texas Children s Hospital Baylor College of Medicine, Houston, Texas, United States
Novartis Investigative Site, Caba, Buenos Aires, Argentina
Novartis Investigative Site, Randwick, New South Wales, Australia
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Brussels, , Belgium
Novartis Investigative Site, Barretos, SP, Brazil
Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Brno, , Czechia
Novartis Investigative Site, Praha 5, , Czechia
Novartis Investigative Site, Copenhagen, , Denmark
Novartis Investigative Site, Tampere, , Finland
Novartis Investigative Site, Lille Cedex, , France
Novartis Investigative Site, Lyon, , France
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Strasbourg, , France
Novartis Investigative Site, Toulouse Cedex, , France
Novartis Investigative Site, Villejuif, , France
Novartis Investigative Site, Augsburg, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Gottingen, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Heidelberg, , Germany
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Petach-Tikva, , Israel
Novartis Investigative Site, Tel-Hashomer, , Israel
Novartis Investigative Site, Firenze, FI, Italy
Novartis Investigative Site, Genova, GE, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Torino, TO, Italy
Novartis Investigative Site, Fukuoka city, Fukuoka, Japan
Novartis Investigative Site, Setagaya-ku, Tokyo, Japan
Novartis Investigative Site, Osaka, , Japan
Novartis Investigative Site, Utrecht, CS, Netherlands
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Valencia, , Spain
Novartis Investigative Site, Stockholm, , Sweden
Novartis Investigative Site, Zuerich, , Switzerland
Novartis Investigative Site, Leeds, , United Kingdom
Novartis Investigative Site, Liverpool, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR