Back to resultsMasitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Primary Purpose
Metastatic Castrate Resistant Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib
Docetaxel
Prednisone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castrate Resistant Prostate Cancer focused on measuring metastatic castration-resistant prostate cancer, metastatic hormone-resistant prostate cancer, tyrosine kinase inhibitor, mCRPC, mHRPC
Eligibility Criteria
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:
1. Patient who has been previously treated with chemotherapy.
Sites / Locations
- Centre Hospitalier Universitaire de Sherbrooke
- Polyclinique d'oncologie de Gentilly
- Sanjay Gandhi Post Graduate Institute of Medical Sciences
- Centro di Riferimento Oncologico
- Istituto Europeo di Oncologia
- Azienda Ospedaliero Universitaria Pisana
- Universiti Malaya Medical Centre
- Clinical Oncology Dispensary
- Clinic Andros LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Masitinib & docetaxel
Placebo & docetaxel
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Progression Free Survival
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03761225
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castrate Resistant Prostate Cancer
Keywords
metastatic castration-resistant prostate cancer, metastatic hormone-resistant prostate cancer, tyrosine kinase inhibitor, mCRPC, mHRPC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
714 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masitinib & docetaxel
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo & docetaxel
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
From day of randomization to disease progression or death, assessed for a maximum of 60 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
From day of randomization to death, assessed for a maximum of 60 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
1. Patient who has been previously treated with chemotherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Spaeth, MD
Organizational Affiliation
Polyclinique d'oncologie de Gentilly, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
ZIP/Postal Code
13001
Country
Canada
Facility Name
Polyclinique d'oncologie de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Sanjay Gandhi Post Graduate Institute of Medical Sciences
City
Lucknow
ZIP/Postal Code
226014
Country
India
Facility Name
Centro di Riferimento Oncologico
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Universiti Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Clinic Andros LLC
City
St. Petersburg
ZIP/Postal Code
197136
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer
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