Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Docetaxel; Epothilone B; Epothilones; Hormones; Prednisone

Criteria

Inclusion criteria:

• Must be ≥ 18 years of age

• Confirmed and documented diagnosis of prostate cancer

• Confirmed and documented evidence of progression of disease (hormone refractory)

• Low testosterone levels

• Chemotherapy-naïve

Exclusion criteria:

• Recent radiation therapy (within 4 weeks)

• Known brain metastasis

• Peripheral neuropathy

• Active diarrhea

• Significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections

• Allergic reactions to patupilone or docetaxel or prednisone or similar compounds

Other protocol-defined inclusion/exclusion criteria may apply