Study of efficacy and safety of dabrafenib in combination with trametinib in pediatric patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory HGG tumors

Phase 1

• Conditions: Paediatric patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG); MedDRA version: 20.0Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004015-20-CZ
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-02
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

Key
- Male or female between = 12 months and <18 years of age at the time of signing the informed consent form
-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

Additional protocol-related inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 142
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
Additional protocol-related exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified