VS-6063 Phase II Mesothelioma study
Research type
Research Study
Full title
A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of VS 6063 in Subjects with Malignant Pleural Mesothelioma
IRAS ID
131237
Contact name
Dean Fennell
Contact email
Sponsor organisation
Verastem Inc
Eudract number
2013-001033-40
Clinicaltrials.gov Identifier
Research summary
Malignant pleural mesothelioma (MPM) has become an increasingly common cancer in the industrial world. It is a very aggressive cancer found in the lining of the lung which is often caused by exposure to asbestos. Tumours usually arise 30 years or more after exposure and 80% occur in men. The incidence of MPM is rising worldwide and expected to peak in another 10-20 years. The survival of MPM patients is between 9 and 13 months. There are very few treatment options. Most patients are treated with first line chemotherapy with pemetrexed/cisplatin or pemetrexed/carboplatin for 4-6 cycles. Following this, patients are still relatively healthy but when disease progression occurs the benefit of 2nd line chemotherapy has not been established. It would be advantageous to maintain their disease control following the 1st line chemotherapy and VS-6063 aims to do this. This study will recruit MPM patients who have already received first line chemotherapy (at least 4 cycles of Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) and whose disease has not worsened. Patients will be treated in a blinded way, with either the active study drug, VS6063 or a placebo, dummy drug. VS6063 is known as a focal adhesion kinase (FAK)reversible inhibitor and works by preventing the detachment of cancer stem cells from the main tumour and the disease spreading. The safety, tolerability and effectiveness of VS6063 in patients with MPM will be evaluated. This study will also measure the expression of protein called MERLIN (moesin-exrin-radixin-like protein)as 40% of MPM patients do not have this protein. It is thought that the VS6063 will have a more prolonged affect on controlling the disease in merlin negative patients. Patients merlin status will be established prior to randomisation and each group, positive and negative for merlin will be randomised to either VS6063 or placebo.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0230
Date of REC Opinion
26 Jul 2013
REC opinion
Further Information Favourable Opinion