Clinical trial NCT03761225: Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Castrate Resistant Prostate Cancer
Keywords: metastatic castration-resistant prostate cancer
metastatic hormone-resistant prostate cancer
tyrosine kinase inhibitor
mCRPC
mHRPC
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 714
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
Secondary outcomes:
measure: Overall Survival
timeFrame: From day of randomization to death, assessed for a maximum of 60 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
city: Nancy
country: France
facility: Polyclinique d'oncologie de Gentilly
city: Lucknow
country: India
facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya Medical Centre
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary
city: St. Petersburg
country: Russian Federation
facility: Clinic Andros LLC
Study officials:
affiliation: Polyclinique d'oncologie de Gentilly, Nancy, France
name: Dominique Spaeth, MD
role: PRINCIPAL_INVESTIGATOR
References: