Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

AB Science

Status and phase: Completed; Phase 3

Conditions: Metastatic Castrate Resistant Prostate Cancer

Treatments: Drug: Prednisone; Drug: Masitinib; Drug: Docetaxel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03761225

AB12003

Details and patient eligibility

About

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

Full 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.

Enrollment: 714 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

714 participants in 2 patient groups, including a placebo group

Masitinib & docetaxel

Experimental group

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.

Treatment:

Drug: Docetaxel

Drug: Prednisone

Drug: Masitinib

Placebo & docetaxel

Placebo Comparator group

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.

Treatment:

Drug: Docetaxel

Drug: Prednisone

Drug: Placebo