Status:
COMPLETED
Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Lead Sponsor:
AB Science
Conditions:
Metastatic Castrate Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 1\. Patient who has been previously treated with chemotherapy.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
714 Patients enrolled
Trial Details
Trial ID
NCT03761225
Start Date
September 1 2014
End Date
December 15 2020
Last Update
September 29 2023
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Canada, 13001
2
Polyclinique d'oncologie de Gentilly
Nancy, France, 54100
3
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, India, 226014
4
Centro di Riferimento Oncologico
Aviano, Italy, 33081