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Kinase Inhibitor

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

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approx. 3.2 years and up to approx. 4.8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests dabrafenib and trametinib in children and teenagers with specific brain tumors that are hard to treat. The drugs work by blocking signals that make cancer cells grow. The goal is to see if this combination can help slow down or stop the tumors. Both drugs are already approved for treating certain types of cancers.

Eligible Conditions

Ganglioglioma
Brain Tumor
Angiocentric Glioma
Cerebellar Iponeurocytoma
Glioneuronal Tumor
Extraventricular Neurocytoma
Gangliocytoma
Solid Tumors
Giant Cell Astrocytoma
Pleomorphic Xanthoastrocytoma
Chordoid Glioma
Desmoplastic Infantile Astrocytoma and Ganglioglioma
Lhermitte-Duclos disease
Astrocytoma
Protoplasmic Astrocytoma
Oligodendroglioma
Anaplastic Ganglioglioma
Childhood Brain Tumors
Glioblastoma
Diffuse Astrocytoma
Anaplastic Astrocytoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approx. 3.2 years and up to approx. 4.8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approx. 3.2 years and up to approx. 4.8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approx. 3.2 years and up to approx. 4.8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria

LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using Response Assessment in Neuro-Oncology (RANO) Criteria

Secondary study objectives

AUClast for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)

AUClast for Trametinib

AUCtau for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)

+41 more

Other study objectives

HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria (Longer Follow-up Time)

LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria (Longer Follow-up Time)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: LGG cohort: dabrafenib and trametinibExperimental Treatment2 Interventions

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)

Group II: HGG cohort: dabrafenib and trametinibExperimental Treatment2 Interventions

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)

Group III: LGG cohort: carboplatin and vincristineActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

trametinib

2018

Completed Phase 2

~260

Dabrafenib

2011

Completed Phase 3

~4120