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
PHASE1
17 participants
INTERVENTIONAL
2009-01-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
6 patients have been enrolled, the cohort has been completed.
BN83495 (Cohort 1)
20 mg daily BN83495 for 28 days
Cohort 2
6 patients have been enrolled in cohort 2, the cohort has been completed.
BN83495 (Cohort 2)
40 mg daily BN83495 for 28 days
Cohort 3
5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.
BN83495 (Cohort 3)
60 mg daily BN83495 for 28 days
Interventions
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BN83495 (Cohort 1)
20 mg daily BN83495 for 28 days
BN83495 (Cohort 2)
40 mg daily BN83495 for 28 days
BN83495 (Cohort 3)
60 mg daily BN83495 for 28 days
Eligibility Criteria
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Inclusion Criteria
* Over age 18.
* Demonstrated PSA "biochemical failure".
* Adequate bone marrow and hepatic function
Exclusion Criteria
* Prior treatment with ketoconazole
* Prior chemotherapy for hormone refractory prostate cancer
* Pre-existing cardiac failure and/or clinically significant abnormal ECG or Echo
18 Years
MALE
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Johns Hopkins University Medical Center
Baltimore, Maryland, United States
Duke University Medical Center United States
Durham, North Carolina, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Other Identifiers
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X-52-58064-003
Identifier Type: -
Identifier Source: org_study_id
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