Dabrafenib and Trametinib in Paediatric High Grade Glioma
Research type
Research Study
Full 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 relapsed or refractory High Grade Glioma (HGG)
IRAS ID
230234
Contact name
Darren Hargrave
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2015-004015-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 9 months, 2 days
Research summary
Summary of Research
This study will test the safety and effects of Dabrafenib and Trametinib on relapsed high grade glioma brain cancer, which has a specific mutation called BRAF V600, in children between 6 years old to under 18 years old. Dabrafenib and Trametinib are currently approved for use in melanoma, a skin cancer, and from other studies it is thought they may be effective in helping to treat high grade glioma. They work by interfering with the growth and spread of cancer cells in the body. About 9600 people have received dabrafenib or dabrafenib with trametinib. The study will take place in children's hospital outpatient clinics. Dabrafenib is given by mouth twice daily and Trametinib is given by mouth once daily until no longer in the best interests of the patient. After passing an eligibility check, hospital visits will be weekly until Week 5, then at Week 8, then every 8 weeks until the end of the first year, after which they will be every 16 weeks. Most visits include: blood and urine samples, general health check and heart imaging tests, and an MRI scan to measure the cancer. A wrist or leg x-ray will be done every 16 weeks to monitor growth. A skin and eye examination will be done every 16 weeks. Extra blood samples will be taken at several time points at Visits 1, 3 and 4 to see how study medication is absorbed and used by the body. At Visit 3, this may need an overnight hospital stay as blood samples will be taken up to 8 hours after taking the study medication. Patients or parents/carers will be asked to record any seizures in a diary between visits. Female patients with child bearing capability will be asked to have monthly urine pregnancy tests whilst on study medication.
Summary of results
A lay summary will not be published. Per Novartis SOPs, we commit to providing a plain language summary for studies with approved final protocol synopsis from 01 Sep 2018.
REC name
London - Central Research Ethics Committee
REC reference
17/LO/1863
Date of REC Opinion
9 Jan 2018
REC opinion
Further Information Favourable Opinion