Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

Metastatic Castrate Resistant Prostate Cancer Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761225
• Other study ID #: AB12003
• Status: Completed
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: December 15, 2020

Study information

• Verified date: September 2023
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 714
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed metastatic Castrate Resistant Prostate Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone < 0.5ng/ml) with one of the following criteria:

• Pre-treated with abiraterone with documented progressive disease, OR

• Indicated for initiating docetaxel treatment (e.g., widespread visceral disease or rapidly progressive disease).

2. Patient with evidence of progressive metastatic disease as assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations.

3. Patient with adequate organ function as per protocol

Exclusion Criteria:

1. Patient who has been previously treated with chemotherapy.

Related Conditions & MeSH terms

• Metastatic Castrate Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Masitinib

• Docetaxel

• Prednisone

• Placebo

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke
France	Polyclinique d'oncologie de Gentilly	Nancy
India	Sanjay Gandhi Post Graduate Institute of Medical Sciences	Lucknow
Italy	Centro di Riferimento Oncologico	Aviano
Italy	Istituto Europeo di Oncologia	Milano
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Malaysia	Universiti Malaya Medical Centre	Kuala Lumpur
Russian Federation	Clinical Oncology Dispensary	Omsk
Russian Federation	Clinic Andros LLC	St. Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

Canada,  France,  India,  Italy,  Malaysia,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Progression Free Survival (PFS) is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations.	From day of randomization to disease progression or death, assessed for a maximum of 60 months
Secondary	Overall Survival	Overall survival (OS) is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.	From day of randomization to death, assessed for a maximum of 60 months