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Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761225
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
AB Science

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : December 15, 2020
Actual Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

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 Name: 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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761225


Locations
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Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Canada, 13001
France
Polyclinique d'oncologie de Gentilly
Nancy, France, 54100
India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, India, 226014
Italy
Centro di Riferimento Oncologico
Aviano, Italy, 33081
Istituto Europeo di Oncologia
Milano, Italy, 20141
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56100
Malaysia
Universiti Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Russian Federation
Clinical Oncology Dispensary
Omsk, Russian Federation, 644013
Clinic Andros LLC
St. Petersburg, Russian Federation, 197136
Sponsors and Collaborators
AB Science
Investigators
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Principal Investigator: Dominique Spaeth, MD Polyclinique d'oncologie de Gentilly, Nancy, France
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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT03761225    
Other Study ID Numbers: AB12003
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AB Science:
metastatic castration-resistant prostate cancer
metastatic hormone-resistant prostate cancer
tyrosine kinase inhibitor
mCRPC
mHRPC
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal