Pediatric Long-Term Follow-up and Rollover Study

Summary

A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.

Conditions

• 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 Glioneuronal Tumor
• Central Neurocytoma
• Extraventricular Neurocytoma
• Cerebellar Liponeurocytoma
• Neurofibromatosis Type 1

Interventions

DRUG

dabrafenib

dabrafenib oral, twice daily

DRUG

trametinib

trametinib oral, once daily

Sponsors & Collaborators

• Novartis Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-04

Primary Completion

2026-11-05

Completion

2026-11-05

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Belgium
• Brazil
• Canada
• Czechia
• Denmark
• Finland
• France
• Germany
• Israel
• Italy
• Japan
• Netherlands
• Russia
• Spain
• Sweden
• United Kingdom

Study Locations