VS-6063-104 Phase 1 study in relapsed malignant mesothelioma
Research type
Research Study
Full title
A Phase 1 Dose Escalation Study of VS-5584, a Dual PI3K/mTOR Inhibitor, Administered with a Fixed Dose of VS-6063, a Focal Adhesion Kinase Inhibitor, in Subjects with Relapsed Malignant Mesothelioma.
IRAS ID
163827
Contact name
Udai Banerji
Contact email
Sponsor organisation
Verastem, Inc.
Eudract number
2014-003310-89
Clinicaltrials.gov Identifier
119,163 and 117,163, Investigation New Drug numbers
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
VS-5584 and VS-6063 are new anticancer treatments that are being developed, with the potential of effect on a variety of cancer types. They have not yet been approved for use by the regulatory authorities. Laboratory studies have shown superior anti-tumour efficacy when VS-5584 and VS-6063 are given together. This study is being carried out to investigate the safety and tolerability of VS-5584 taken in combination with VS-6063, in patients with malignant mesothelioma who have received at least 3 cycles of first-line chemotherapy but have relapsed.
There are two parts in the study. In Part 1 (dose-escalation) up to 36 patients will be enrolled in groups of 3, each group receiving increasing dose levels of VS-5054 with a fixed dose of VS-6063, until the maximum tolerated dose of VS-5054 can be established. In Part 2 (dose expansion) up to 20 patients will be enrolled and receive the dose of VS-5054 established in Part 1 together with a fixed dose of VS-6063.
The study is planned to run in up to 6 sites.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/1996
Date of REC Opinion
10 Dec 2014
REC opinion
Further Information Favourable Opinion