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

Metastatic Hormone Refractory Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411528
• Other study ID #: CEPO906A2229
• Secondary ID: 2006-001822-23
• Status: Completed
• Phase: Phase 2
• Start date: September 2006
• Est. completion date: September 2012

Study information

• Verified date: September 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Hormone Refractory Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Patupilone

• prednisone

• docetaxel

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Parkville	Victoria
Australia	Novartis Investigative Site	South Brisbane	Queensland
Belgium	Novartis Investigative Site	Gent
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Colmar Cedex
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Rouen Cedex
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Toulouse Cedex 3
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Weiden
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Perugia	PG
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucía
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
United States	University of Colorado Dept. of Univ. of Colorado	Aurora	Colorado
United States	University Chicago Hospital StudyCoordinator:CEPO906A2229	Chicago	Illinois
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	University of California San Diego Dept of Moores Cancer Center	La Jolla	California
United States	NorthWest Georgia Oncology Centers Marietta Center	Marietta	Georgia
United States	Norwalk Hospital	Norwalk	Connecticut
United States	MD Anderson Cancer Center - Orlando CEPO906A2229	Orlando	Florida
United States	Oregon Health & Science University StudyCoordinator:CEPO906A2229	Portland	Oregon
United States	H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology	Tampa	Florida
United States	Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center	Washington	District of Columbia
United States	Palm Beach Cancer Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Italy,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor response based on PSA decrease		Every 3 weeks
Secondary	Measurable soft tissue response for both regimens		Every 6 weeks or every 12 weeks if patient has bone disease for bone scan

External Links

•   Prostrate Cancer Study
•   Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.