Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

Sponsor

AB Science (Industry)

Overall Status

Completed

CT.gov ID

NCT03761225

Collaborator

(none)

714

Enrollment

Locations

Arms

75.5

Actual Duration (Months)

79.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Castrate Resistant Prostate Cancer	Drug: Masitinib Drug: Docetaxel Drug: Prednisone Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

714 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Dec 15, 2020

Actual Study Completion Date :

Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Masitinib & docetaxel Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus docetaxel 75 mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.	Drug: Masitinib Other Names: AB1010 Drug: Docetaxel Drug: Prednisone
Placebo Comparator: Placebo & docetaxel Participants receive placebo (6 mg/kg/day), given orally twice daily, plus docetaxel 75 mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.	Drug: Docetaxel Drug: Prednisone Drug: Placebo

Arm

Intervention/Treatment

Experimental: Masitinib & docetaxel

Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus docetaxel 75 mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.

Drug: Masitinib

Other Names:

AB1010

Drug: Docetaxel

Drug: Prednisone

Placebo Comparator: Placebo & docetaxel

Participants receive placebo (6 mg/kg/day), given orally twice daily, plus docetaxel 75 mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.

Drug: Docetaxel

Drug: Prednisone

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Progression Free Survival [From day of randomization to disease progression or death, assessed for a maximum of 60 months]
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.

Secondary Outcome Measures

Overall Survival [From day of randomization to death, assessed for a maximum of 60 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

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

Exclusion Criteria:

Patient who has been previously treated with chemotherapy.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Canada	13001
2	Polyclinique d'oncologie de Gentilly	Nancy	France	54100
3	Sanjay Gandhi Post Graduate Institute of Medical Sciences	Lucknow	India	226014
4	Centro di Riferimento Oncologico	Aviano	Italy	33081
5	Istituto Europeo di Oncologia	Milano	Italy	20141
6	Azienda Ospedaliero Universitaria Pisana	Pisa	Italy	56100
7	Universiti Malaya Medical Centre	Kuala Lumpur	Malaysia	59100
8	Clinical Oncology Dispensary	Omsk	Russian Federation	644013
9	Clinic Andros LLC	St. Petersburg	Russian Federation	197136