GO28399 Open label extension study of Vemurafenib
Research type
Research Study
Full title
AN OPEN-LABEL, EXTENSION (ROLLOVER) STUDY OF VEMURAFENIB IN PATIENTS WITH BRAFV600 MUTATION-POSITIVE MALIGNANCIES PREVIOUSLY ENROLLED IN AN ANTECEDENT VEMURAFENIB PROTOCOL
IRAS ID
122461
Contact name
James Larkin
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2012-003144-80
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.This study offers continuous access of vemurafenib for eligible patients with BRAFV600 mutation-positive malignancy, who were previously enrolled and treated in a vemurafenib protocol and did not meet the protocol’s criteria for disease progression, or are being treated beyond progression and are still deriving clinical benefit (as assessed by the investigator), and may therefore potentially benefit from continued treatment with vemurafenib. Patients with malignant tumour types other than malignant melanoma, which also harbour a V600-activating mutation of BRAF and who have no acceptable standard treatment options, will also be allowed to participate in the trial.
Patients will proceed into this extension (rollover) study with a maximum window of 15 days following the last study day in the previous protocol. The first vemurafenib treatment in the extension (rollover) study will be recorded as Cycle 1, Day 1. One cycle is defined as 28 days. Clinic visits will occur on Day 1 of Cycles 1 through 7 and on Day 1 of every other cycle through Cycle 15. For patients still receiving treatment, clinic visits will occur on Day 1 of every third cycle.
Patients will receive treatment with oral vemurafenib at 960 mg, 720mg or 480mg twice a day, depending on the last dose in the antecedent protocol. Treatment will continue until progression of disease or as long as the patient is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurs first.
In addition, this study will examine how safe and well tolerated vemurafenib is for patients during this further treatment. The number of patients who will take part in this study is indefinite and will be determined by the number of patients who continue on vemurafenib following enrolment in previous studies.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
14/SC/1236
Date of REC Opinion
6 Oct 2014
REC opinion
Further Information Favourable Opinion