Vemurafenib in patients with BRAF V600 mutation-positive cancers
Research type
Research Study
Full title
An open-label, phase II study of vemurafenib in patients with BRAF V600 mutation-positive cancers
IRAS ID
98077
Contact name
Ian Chau
Sponsor organisation
F. Hoffman-La Roche Ltd.
Eudract number
2011-004426-10
Clinicaltrials.gov Identifier
Research summary
Previous studies have shown that vemurafenib can help patients with a type of metastatic melanoma caused by a problem in a gene called BRAF. In this study, we hope to learn whether vemurafenib is safe and effective in other types of cancers caused by the same problem gene. This is an open-label, multicentre, multinational, phase II study exploring the efficacy and safety of vemurafenib in patients aged over 18 years with cancers with the problem in the BRAF gene. It is estimated that approximately 104-152 patients will be enrolled in the study in 8 groups each with approximately 13??19 patients with a different cancer type. (The groups are: non-small cell lung carcinoma; ovarian cancer; colorectal cancer; breast cancer; prostate cancer; multiple myeloma, cholangiocarcinoma/cancer of the biliary tract; or solid tumours other than the above). Patients will be recruited from sites in the US and Europe, including 2 hospitals in the UK recruiting 15 patients. The trial will consist of a screening period lasting up to 28 days. Eligible patients then receive continuous oral dosing of vemurafenib at 960 mg twice daily until their disease gets worse, unacceptable side effects, withdrawal of consent, violation of the study rules that might put the patient in danger, other reasons deemed critical by the treating physician, or study termination by the organising company. Patients will be asked to attend clinic visits every 28 days during the treatment period for safety and efficacy assessments to be undertaken. An end-of-treatment visit will occur when vemurafenib is discontinued for any reason. This will be followed by a safety follow-up visit 28 days after the last dose of vemurafenib. There will be a survival follow-up period lasting for a maximum of 12 months with the survival status of the patient recorded every 3 months.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
12/LO/0443
Date of REC Opinion
11 May 2012
REC opinion
Further Information Favourable Opinion