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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00411528 |
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Date of registration:
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12/12/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Patupilone in Men (=18 Years) With Metastatic Hormone Refractory Prostate Cancer
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Scientific title:
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A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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185 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00411528 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Belgium
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France
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Germany
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Italy
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Singapore
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Spain
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Metastatic Hormone Refractory Prostate Cancer
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Intervention(s)
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Drug: docetaxel
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Drug: Patupilone
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Drug: prednisone
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Primary Outcome(s)
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Antitumor response based on PSA decrease
[Time Frame: Every 3 weeks]
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Secondary Outcome(s)
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Measurable soft tissue response for both regimens
[Time Frame: Every 6 weeks or every 12 weeks if patient has bone disease for bone scan]
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Secondary ID(s)
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2006-001822-23
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CEPO906A2229
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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