Loading clinical trials...

Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer

NCT00411528•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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

Locations (32)

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

Key Dates

Start Date

September 1, 2006

Primary Completion Date

September 1, 2012

Completion Date

September 1, 2012

Last Updated

December 17, 2020

Enrollment

185

ACTUAL participants

Conditions

Metastatic Hormone Refractory Prostate Cancer

Interventions

Patupilone

DRUG

prednisone

DRUG

docetaxel

DRUG

PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

NCT00766324

Metastatic Hormone Refractory Prostate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions