Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

Sponsor
AB Science
Study ID
NCT03761225
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic Castrate Resistant Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Masitinib — DRUG
  • Docetaxel — DRUG
  • Prednisone — DRUG
  • Placebo — DRUG

Study Details

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

Key Dates

Start date
Sep 30, 2014
Status verified
Sep 2023
Primary completion
Dec 15, 2020
Completion
Dec 15, 2020

Study Design

Enrollment
714 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Progression Free Survival [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months ]

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