NCT03761225

Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 714 (actual)
• Sponsor: AB Science · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer.

Detailed description

The objective of this study is to evaluate the efficacy and safety of masitinib in combination with docetaxel and prednisone with respect to placebo in combination with docetaxel and prednisone in the treatment of first line metastatic Castrate Resistant Prostate Cancer (mCRPC). Approximately 580 patients will be randomized in 2 groups with a ratio 1:1. The primary outcome measure is progression free survival. Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment.

Conditions

• Metastatic Castrate Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Masitinib
DRUG	Docetaxel
DRUG	Prednisone
DRUG	Placebo

Timeline

• Start date: 2014-09-01
• Primary completion: 2020-12-15
• Completion: 2020-12-15
• First posted: 2018-12-03
• Last updated: 2023-09-29

Locations

9 sites across 6 countries: Canada, France, India, Italy, Malaysia, Russia

Regulatory

• FDA-regulated drug study