Status:
COMPLETED
BN83495 in Prostate Cancer
Lead Sponsor:
Ipsen
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy
Detailed Description
Evaluate the PD profile of BN83495 after 28 days of daily oral administration in patients with locally advanced or metastatic prostate cancer on androgen ablative therapy and with rising prostatic spe...
Eligibility Criteria
Inclusion
- Confirmed and locally advanced or metastatic prostate cancer with rising prostate-specific antigen (PSA), while on androgen ablative therapy.
- Over age 18.
- Demonstrated PSA "biochemical failure".
- Adequate bone marrow and hepatic function
Exclusion
- Luteinizing Hormone-Releasing Hormone analogue treatment and treated with more than one additional second line of endocrine therapy
- Prior treatment with ketoconazole
- Prior chemotherapy for hormone refractory prostate cancer
- Pre-existing cardiac failure and/or clinically significant abnormal ECG or Echo
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00790374
Start Date
January 1 2009
End Date
February 1 2011
Last Update
January 15 2019
Active Locations (3)
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1
Johns Hopkins University Medical Center
Baltimore, Maryland, United States, 21231
2
Duke University Medical Center United States
Durham, North Carolina, United States, 27705
3
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53705