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

Completed · Phase 2

Conditions studied: Metastatic Hormone Refractory Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00411528

Run by

Novartis Pharmaceuticals

People needed

185

Starts

2006-09-01

Expected to finish

2012-09-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Diego Dept of Moores Cancer Center — La Jolla, California, United States
• University of Colorado Dept. of Univ. of Colorado — Aurora, Colorado, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• MD Anderson Cancer Center - Orlando CEPO906A2229 — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology — Tampa, Florida, United States
• Palm Beach Cancer Institute — West Palm Beach, Florida, United States
• NorthWest Georgia Oncology Centers Marietta Center — Marietta, Georgia, United States
• University Chicago Hospital StudyCoordinator:CEPO906A2229 — Chicago, Illinois, United States
• Queens Cancer Center of Queens Hospital — Jamaica, New York, United States
• Oregon Health & Science University StudyCoordinator:CEPO906A2229 — Portland, Oregon, United States
• Novartis Investigative Site — Kogarah, New South Wales, Australia
• Novartis Investigative Site — South Brisbane, Queensland, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Bordeaux, France
• Novartis Investigative Site — Colmar, France
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Rouen, France
• Novartis Investigative Site — Strasbourg, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Mannheim, Germany
• Novartis Investigative Site — Weiden, Germany
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Milan, MI, Italy

Full record on ClinicalTrials.gov

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