Dabrafenib and Trametinib paediatric roll-over study
Research type
Research Study
Full title
An open label, multi-center roll-over study to assess long-term effect in pediatric patients treated with Tafinlar (dabrafenib) and/or Mekinist (trametinib)
IRAS ID
269630
Contact name
Darren Hargrave
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-004459-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 7 months, 15 days
Research summary
This study is a roll-over study from several currently ongoing clinical trials (parent protocols) in paediatric patients using dabrafenib, trametinib or a combination of both treatments. It will facilitate data collection of the long-term outcomes of paediatric subjects who have been treated in clinical trials with dabrafenib, trametinib or the combination, to assess the long-term effect on growth, development and general health of these subjects. Additionally, it will provide a mechanism to continue treatment with a reduced visit burden for patients currently benefitting from treatment in one of the parent protocols.
Subjects will continue on the same treatment as they were taking in the parent protocol at the same dose for as long as they continue to benefit from the treatment. They will then be followed up post treatment every 6 months (subjects with High Grade Glioma, HGG) or 12 months (all other subjects).
Visits will take place in children’s hospital outpatient clinics. Visits will take place every 3 months during the treatment phase of the study. Clinic visits will take place every 6 months for all patients, with the 3 monthly visit assessments being performed by telephone. Some subjects will visit every 3 months to collect additional supplies of medication. If patients are in-patients at any time during the study, clinic visits may be conducted at the same time.
Clinic visits will include the following assessments: physical examination, height and weight, vital signs, skin examination (once per year), eye examination, electrocardiogram (ECG), blood samples, urine samples, heart scan, x-ray of wrist or leg to monitor growth (once per year). Female patients with child-bearing capability (any menstruating females) will be asked to take monthly urine pregnancy tests at home while on study treatment.
3-monthly visits will include collection of information about changes in medication and how the subject has been feeling (adverse event information).REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0081
Date of REC Opinion
12 May 2020
REC opinion
Further Information Favourable Opinion