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
2 other identifiers
interventional
185
8 countries
32
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 refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2006
Longer than P75 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 12, 2006
CompletedFirst Posted
Study publicly available on registry
December 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedDecember 17, 2020
September 1, 2020
6 years
December 12, 2006
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antitumor response based on PSA decrease
Every 3 weeks
Secondary Outcomes (1)
Measurable soft tissue response for both regimens
Every 6 weeks or every 12 weeks if patient has bone disease for bone scan
Study Arms (4)
1: 8 mg/m2 study drug + prednisone
EXPERIMENTALPatupilone 8 mg/m2 + prednisone 5 mg bid daily
2: study drug + prednisone days 1 -8
EXPERIMENTALPatupilone 10 mg/m2 + prednisone days 1 -8 at 25 mg bid, day 9 at 20 mg bid, day 10 at 15 mg bid, day 11 at 10 mg bid, day 12 - 21 at 5 mg bid
3: Study drug + prednisone days 1 - 4
EXPERIMENTALPatupilone 10 mg/m2 + prednisone days 1 - 4 at 5 mg bid, days 5 -12 at 25 mg bid, day 13 at 20 mg bid, day 14 at 15 mg bid, day 15 at 10 mg bid, day 16 - 21 at 5 mg bid
4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily
ACTIVE COMPARATORDocetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
University of California San Diego Dept of Moores Cancer Center
La Jolla, California, 92093-0658, United States
University of Colorado Dept. of Univ. of Colorado
Aurora, Colorado, 80045, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center
Washington D.C., District of Columbia, 20007-2197, United States
MD Anderson Cancer Center - Orlando CEPO906A2229
Orlando, Florida, 32806, United States
H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology
Tampa, Florida, 33612, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
NorthWest Georgia Oncology Centers Marietta Center
Marietta, Georgia, 30060, United States
University Chicago Hospital StudyCoordinator:CEPO906A2229
Chicago, Illinois, 60637, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432, United States
Oregon Health & Science University StudyCoordinator:CEPO906A2229
Portland, Oregon, 97239, United States
Novartis Investigative Site
Kogarah, New South Wales, 2217, Australia
Novartis Investigative Site
South Brisbane, Queensland, 4101, Australia
Novartis Investigative Site
Parkville, Victoria, 3050, Australia
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Bordeaux, 33075, France
Novartis Investigative Site
Colmar, 68024, France
Novartis Investigative Site
Lille, 59020, France
Novartis Investigative Site
Rouen, 76031, France
Novartis Investigative Site
Strasbourg, 67091, France
Novartis Investigative Site
Toulouse, 31052, France
Novartis Investigative Site
Mannheim, 68135, Germany
Novartis Investigative Site
Weiden, 92637, Germany
Novartis Investigative Site
Milan, MI, 20133, Italy
Novartis Investigative Site
Milan, MI, 20141, Italy
Novartis Investigative Site
Perugia, PG, 06129, Italy
Novartis Investigative Site
Singapore, 169610, Singapore
Novartis Investigative Site
Málaga, Andalusia, 29010, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08036, Spain
Novartis Investigative Site
Valencia, Valencia, 46009, Spain
Novartis Investigative Site
Madrid, 28034, Spain
Novartis Investigative Site
Madrid, 28041, Spain
Related Publications (1)
de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
PMID: 24722180DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2006
First Posted
December 14, 2006
Study Start
September 1, 2006
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
December 17, 2020
Record last verified: 2020-09