STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling

A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling

In this research study, the investigators are looking to determine the safety and efficacy of an investigational drug, STA9090 alone and in combination with dutasteride for the treatment of castrate resistant prostate cancer. STA9090 may cause the growth of cancer to slow down or shrink by targeting proteins required for the cancer to grow. The investigators are also looking to determine whether the use of dutasteride to lower male hormone levels will enhance the effect of STA9090 in the treatment of castrate resistant prostate cancer.

Subjects will have a tumor biopsy before treatment begins. Subjects who are randomized to Arm A will receive infusions of STA9090 on days 1, 8, and 15 of a 28 day cycle. Subjects randomized on Arm B will receive daily oral dutasteride for 2 weeks prior to beginning STA9090 treatment. They will continue to receive dutasteride while on study.

Inclusion Criteria:

• Adenocarcinoma of the prostate
• Progressive castration resistant disease
• Metastatic disease
• Normal organ and marrow function

Exclusion Criteria:

• History of current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass
• Current treatment with the following antiarrhythmic drugs: flecainide, moricizine or propafenone
• New York Heart Association class II/III/IV congestive heart failure
• Current or prior radiation therapy to the left hemithorax
• Treatment with chronic immunosuppressants
• Uncontrolled intercurrent illness
• Poor venous access for study drug administration
• Venous thromboembolism in the past 6 months