Status:
COMPLETED
Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Hormone Refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 refract...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00411528
Start Date
September 1 2006
End Date
September 1 2012
Last Update
December 17 2020
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California San Diego Dept of Moores Cancer Center
La Jolla, California, United States, 92093-0658
2
University of Colorado Dept. of Univ. of Colorado
Aurora, Colorado, United States, 80045
3
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
4
Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007-2197