GO28053 Ph1 Vemurafenib in BRAF V600 mutation positive cancer patients
Research type
Research Study
Full title
AN OPEN LABEL, PHASE I STUDY TO EVALUATE THE IMPACT OF SEVERE HEPATIC IMPAIRMENT ON THE PHARMACOKINETICS AND SAFETY OF VEMURAFENIB IN BRAFV600 MUTATION POSITIVE CANCER PATIENTS
IRAS ID
120756
Contact name
Steve Nicholson
Contact email
Sponsor organisation
F.Hoffmann-La Roche Ltd
Eudract number
2012-003820-18
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Half of melanomas have changes (“mutations“)in a gene called “BRAF“. These mutations cause an increase the growth and spread of the cancer. The same mutations are found in several other cancers, although less frequently.
Vemurafenib is a tablet anticancer drug that works by blocking the signals caused by this altered BRAF gene. Blocking these signals can slow growth of the cancer or cause it to shrink.
Vemurafenib is mainly eliminated from the body via the liver. Patients with significant liver damage were excluded in previous clinical studies. This study will examine the effect that liver damage has on the metabolism of Vemurafenib.The study will enrol approximately 16 patients from 20 hospitals around the world: 8 patients with normal liver function and 8 patients with significantly impaired liver function. Patients will only be entered into the trial if the drug is felt to be a suitable treatment for them and their cancer, and for this reason the majority of patients in this study are expected to have metastatic melanoma.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0291
Date of REC Opinion
27 Sep 2013
REC opinion
Further Information Favourable Opinion