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Completed

NCT Number: NCT03761225

Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

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

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Key information

Conditions

Metastatic Castrate Resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Masitinib

Drug

Other names: AB1010

docetaxel

Drug

Prednisone

Drug

Placebo

Drug

Primary outcomes

  1. Progression Free Survival

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2018
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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