BN83495 in Prostate Cancer

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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