BN83495 in Prostate Cancer

Status:	Completed
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	1/17/2019
Start Date:	January 2009
End Date:	February 2011

A Phase I Dose Escalating Study Evaluating the Pharmacodynamic Profile and Safety of BN83495 in Patients With Prostate Cancer With Evidence of Disease Progression While on Androgen Ablative Therapy

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

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 specific antigen

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

We found this trial at

sites

Johns Hopkins University Medical Center

Baltimore, Maryland 21205

from

Baltimore, MD