Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

• Status: Completed
• Trial end date: 2020-12-15
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science
• Treatments: Docetaxel; Prednisone

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.