Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer
NCT ID: NCT00411528
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2006-09-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1: 8 mg/m2 study drug + prednisone
Patupilone 8 mg/m2 + prednisone 5 mg bid daily
Patupilone
prednisone
2: study drug + prednisone days 1 -8
Patupilone 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
Patupilone
prednisone
3: Study drug + prednisone days 1 - 4
Patupilone 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
Patupilone
prednisone
4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily
Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily
prednisone
docetaxel
Interventions
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Patupilone
prednisone
docetaxel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed and documented diagnosis of prostate cancer
* Confirmed and documented evidence of progression of disease (hormone refractory)
* Low testosterone levels
* Chemotherapy-naïve
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Perugia, PG, Italy
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Countries
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References
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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.
Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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2006-001822-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CEPO906A2229
Identifier Type: -
Identifier Source: org_study_id