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

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.

Condition

Diffuse Astrocytoma

Anaplastic Astrocytoma

Astrocytoma

Oligodendroglioma, Childhood

Anaplastic Oligodendroglioma

Glioblastoma

Pilocytic Astrocytoma

Giant Cell Astrocytoma

Pleomorphic Xanthoastrocytoma

Anaplastic Pleomorphic Xanthoastrocytoma

Angiocentric Glioma

Chordoid Glioma of Third Ventricle

Gangliocytoma

Ganglioglioma

Anaplastic Ganglioglioma

Dysplastic Gangliocytoma of Cerebrellum

Desmoplastic Infantile Astrocytoma and Ganglioglioma

Papillary Glioneuronal Tumor

Rosette-forming Glioneurona Tumor

Central Neurocytoma

Extraventricular Neurocytoma

Cerebellar Iponeurocytoma

Phase

Phase 2

Overall status

Recruiting

Enrollment count

142 participants

Last update

Oct 19, 2020

Start date

Dec 28, 2017

Completion date

Oct 16, 2025

Gender

All

Age(s)

12 Years - 17 Years (Child)

Interventions

Drug

dabrafenib

dabrafenib oral, twice daily.

Drug

trametinib

trametinib oral, once daily.

Drug

Carboplatin with vincristine

Chemotherapy of carboplatin with vincristine - LGG only

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

United States

Phoenix Childrens Hospital

Recruiting

Phoenix, 85016

Arizona

United States

Children's Hospital of Orange County

Recruiting

Orange, 92868

California

United States

Childrens Hospital Colorado

Recruiting

Aurora, 80045

Colorado

United States

Children s National Hospital

Recruiting

Washington, 20010

District of Columbia

United States

Nemours Children's Clinic Division of Endocrinology

Recruiting

Jacksonville, 32207

Florida

United States

Nicklaus Children s Hospital

Recruiting

Miami, 33155

Florida

United States

Ann and Robert H Lurie Childrens Hospital of Chicago

Recruiting

Chicago, 60611

Illinois

United States

Indiana University School of Medicine

Recruiting

Indianapolis, 46202-2810

Indiana

United States

Johns Hopkins University IDS Pharmacy John Hopkins Hospital

Recruiting

Baltimore, 21287

Maryland

United States

Dana Farber Cancer Institute

Recruiting

Boston, 02215

Massachusetts

United States

Children s Mercy Hospital

Recruiting

Kansas City, 64108

Missouri

United States

Washington University School of Medicine SC

Recruiting

Saint Louis, 63110

Missouri

United States

Memorial Sloan Kettering Cancer Center PC-2

Recruiting

New York, 10065

New York

United States

Cincinnati Children's Hospital Medical Center Cancer & Blood Disease Inst.

Recruiting

Cincinnati, 45229-3039

Ohio

United States

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, 15224

Pennsylvania

United States

St Jude Children's Research Hospital

Recruiting

Memphis, 38105

Tennessee

United States

UT Southwestern Medical Center UTSW/Children's Medical Center

Recruiting

Dallas, 75235

Texas

United States

Texas Children s Hospital Baylor College of Medicine

Recruiting

Houston, 77030

Texas

United States

Argentina