Open label study for subjects with BRAF V600 Mutation Positive Tumors
Research type
Research Study
Full title
An Open-label Study to Evaluate the Effects of a Potent CYP3A4 Inducer and the Effects of a pH Elevating Agent on the Repeat Dose Pharmacokinetics of Dabrafenib (GSK2118436) in Subjects with BRAF V600 Mutation Positive Tumors
IRAS ID
170049
Contact name
Henrick-Tobias Arkenau
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2014-003093-17
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
The study is being conducted to evaluate the effect of rifampin (a strong CYP3A4 inducer) and rabeprazole (a pH elevating agent) on the pharmacokinetics (PK) of dabrafenib (a CYP3A4/CYP2C8 substrate). The study will be conducted in patients with BRAF V600 mutation-positive tumours.
The study will last for 29 days, with screening tests being completed within 35 days prior to the first administration of the study treatment. Patients will take Dabrafenib from Day 1 to Day 15, Dabrafenib and Rabeprazole from Day 16 to Day 19, and Dabrafenib and Rifampin from Day 20 to Day 29. A total of 14 blood samples will be collected over 12 hours following dosing on Day 15, Day 19, and Day 29 in order to measure how much of each medication is present in the blood after dosing. Data collected from this study will be used to make recommendations regarding use of concomitant medications with dabrafenib.
There will be one site in the UK, and the study as a whole will recruit 12-20 patients. Eligible patients must be over 18, have a confirmed BRAF V600 Mutation Positive Tumour, be of a certain body mass index, able to swallow the study medications, and have adequate kidney and liver function.
Various tests will take place during screening and throughout the trial. These will include, and are not limited to, blood tests, medical and medication histories, physical exams and discussions, ECG, Echocardiogram and vital signs.
At the end of this study there will be an option for patients to enrol into a roll-over study and continue with Dabrafenib treatment.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/0320
Date of REC Opinion
1 Apr 2015
REC opinion
Further Information Favourable Opinion