Phase 3 Masitinib/Placebo + Docetaxel in Metastatic Prostate Cancer V1
Research type
Research Study
Full title
A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC).
IRAS ID
148489
Contact name
Alain MOUSSY
Contact email
Sponsor organisation
AB Science
Eudract number
2013-000809-23
Research summary
Prostate Cancer is due to the modification of some cells that turn into cancer cells. These changes are called genetic mutations. The reason for these changes is unknown but some genes such as cKit or platelet derived growth factor receptor (PDGFR) are involved. When cancer prostate cells are found in other organs, the cancer is called metastatic prostate cancer.
Indeed, it has become clear that some human diseases are the result of a fault in communication between cells. A category of enzymes plays a basic role in cell signal transmission. In diseases such as metastatic prostate cancer, these enzymes do not function properly. Specific drugs can block malfunctioning enzymes and thus help to treat the diseases. Masitinib is such a drug.
Masitinib is a novel protein-tyrosine kinase inhibitor which, in vitro, potently and selectively inhibits a mutated form of the c-Kit receptor as well as the PDGFR in the same range of concentrations.
This phase 3 study will evaluate the efficacy and safety of masitinib in combination with docetaxel in comparison to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC).
The study will be carried out in 550 patients with definite mCRPC. Patients will be randomly chosen to go into 2 groups of 275 patients: Group 1 patients will receive 6mg/kg/day masitinib + docetaxel + prednisone and Group 2 patients will receive placebo + docetaxel + prednisone.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/1005
Date of REC Opinion
21 Jul 2014
REC opinion
Further Information Favourable Opinion