Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer
- Conditions
- Metastatic Castrate Resistant Prostate Cancer
- Interventions
- Registration Number
- NCT03761225
- Lead Sponsor
- AB Science
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 714
-
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
- Patient who has been previously treated with chemotherapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo & docetaxel Prednisone 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. Placebo & docetaxel Placebo 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. Masitinib & docetaxel Masitinib 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. Masitinib & docetaxel 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. Masitinib & docetaxel Prednisone 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. Placebo & docetaxel 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (9)
Sanjay Gandhi Post Graduate Institute of Medical Sciences
🇮🇳Lucknow, India
Universiti Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Canada
Centro di Riferimento Oncologico
🇮🇹Aviano, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Polyclinique d'oncologie de Gentilly
🇫🇷Nancy, France
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Clinic Andros LLC
🇷🇺St. Petersburg, Russian Federation
Clinical Oncology Dispensary
🇷🇺Omsk, Russian Federation