Trial Information

A Phase 2, Multicenter, Open-Label Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

This is a 2-part, open-label (all people know the identity of the intervention) multicenter,
phase 2 study of the safety and efficacy of the combination of Siltuximab plus Mitoxantrone
versus Mitoxantrone in participants with metastatic (spread of cancer cells from one part of
the body to another) hormone refractory (not responding to treatment) prostate cancer
(abnormal tissue that grows and spreads in the body until it kills) who have received one
prior Docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical
agents) regimen (pattern of giving treatment). Part 1 of the study is single arm where
participants will receive Mitoxantrone, Prednisone, and Siltuximab. Part 2 of the study is
randomized portion (the study drug is assigned by chance), consisting of 2-arms. The
experimental arm will consist of Mitoxantrone, Prednisone, and Siltuximab. The control arm
will consist of treatment with Mitoxantrone and Prednisone. Mitoxantrone will be
administered at a dose of 12 milligram per meter square (mg/m^2) intravenously (into a vein)
as a 30 minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on
Day 1 of each 3-week cycle, until disease progression or unacceptable toxicity (any harmful
effect of a drug or poison) or up to 10 cycles {a maximum cumulative [total sum (of
individual events, experiences, treatments)] dose of approximately 120 mg/m^2}. Siltuximab
will be administered 6 milligram per kilogram (mg/kg) intravenously as a 2 hour infusion,
starting Day 1 of Cycle 1 to continue every 2 weeks until disease progression or
unacceptable toxicity or up to a maximum of 1 year. All participants will receive Prednisone
5 milligram (mg) twice daily starting with the first administration of Mitoxantrone. The
duration of treatment will be a maximum of 12 months for cumulative dose. Radiologic
assessments (Gamma and CT scans) will be performed on Week 12 after the first study agent
dosing, then every 9 weeks until the end of treatment, and then once every three months
until documented disease progression. Tumor response (a mass in a specific area) will be
assessed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Prostate
Specific Antigen (PSA) will be evaluated on Day 1 of every cycle (every 3 weeks). After the
end of study treatment, a treatment visit will be scheduled one month after the last dose of
study agent. There will be short-term follow-up visits (conducted monthly for up to 2
months), followed by long-term follow-up visits (conducted once every 3 months).