BN83495 in Prostate Cancer

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT00790374

Run by

Ipsen

People needed

17

Starts

2009-01-01

Expected to finish

2011-02-01

Last updated by the study team

2019-01-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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