Phase 2 comparing masitinib with gemcitabine in ovarian cancer v1
Research type
Research Study
Full title
A prospective, multicenter, open-label, centrally allocated, active-controlled, phase 2/3 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced/metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third line.
IRAS ID
148092
Contact name
Nicholas (Nick) Reed
Contact email
Sponsor organisation
AB Science
Eudract number
2013-000491-14
Clinicaltrials.gov Identifier
IND Number, 120579
Research summary
Ovarian cancer is the second most common cancer of the female reproductive system, and is the leading cause of death from a gynecologic cancer. Despite advances in surgical and chemotherapy, the resistance of cancer cells to traditional cytotoxic drugs is a major obstacle in therapy of ovarian cancer and most of patients will eventually succumb to their disease, supporting the urgent need to develop alternative treatments. Drugs that block the growth and spread of cancer by targeting molecules involved in tumor growth are looks very promising and may improve effectiveness and decrease the toxicities as well as chemo-resistance in ovarian cancer. Protein tyrosine kinases-PTK (chemical in the blood that cause chemical changes in the body) play a key role in communication between cells and regulate cell life cycle. Disturbance of PTK functioning, has been often observed in cancer and linked to the uncontrolled tumour cell growth, invasion and chemotherapy resistance, justifying the great interest in targeting these molecules for therapies.
AB science has developed a specific kinase inhibitor Masitinib which is a novel tyrosine kinase inhibitor. The phase II study using a combination of gemcitabine + Masitinib to treat patients with pancreatic cancer resulted into great improvement of Progression Free Survival compared to gemcitabine monotherapy or the combination of gemcitabine+Erlotinib. Masitinib may potentiate cytotoxic effect of chemotherapies in various cancer types including ovarian cancer. In addition, Masitinib proved to be safe and well tolerated in clinical setting with no cardiotoxicity reported so far.
The study will evaluate the efficacy and the safety of masitinib in combination with gemcitabine to gemcitabine alone of patients with advanced/metastatic ovarian cancer whose initial treatment has failed.REC name
West of Scotland REC 1
REC reference
14/WS/1001
Date of REC Opinion
30 Jul 2014
REC opinion
Further Information Favourable Opinion