Conditions: Prostate Cancer
Keywords: Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 123
Healthy volunteers: no

Brief summary:
This is a study evaluating the safety and efficacy of the monoclonal antibody olaratumab plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory prostate cancer following disease progression or intolerance on docetaxel-based chemotherapy.

Detailed description:

Arms:
arm 1: 1 cycle = 3 weeks (21 days) arm 2: 1 cycle = 3 weeks (21 days)

Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment.

Interventions: intervention 1: Olaratumab intervention 2: Mitoxantrone intervention 3: Prednisone
Intervention descriptions: intervention 1: 15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8 intervention 2: Mitoxantrone 12 milligrams per square meter (mg/m²) IV Day 1

Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²) intervention 3: 5 mg orally (PO) twice daily (BID) on each day

Protocol document: