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

Condition(s) targeted: Adenocarcinoma of the Prostate

Intervention: STA9090 (Drug); STA9090 with Dutasteride (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Toni Choueiri, MD

Official(s) and/or principal investigator(s):
Toni K Choueiri, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To assess AR transcriptional activity based on expression of a series of AR regulated genes, in baseline and on therapy tumor biopsies in CRPC patients treated with STA- 9090 +/-dutasteride.

Secondary outcome:

To assess the safety and tolerability of STA9090 in men the CRPC

To evaluate progression-free survival (PFS) of men with CRPC treated with STA9090 with or without dutasteride

To evaluate the overall survival of men with metastatic CRPC treated with STA9090 alone or in combination with dutasteride

To determine the response rate of measurable disease if present (RECIST)

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02215, United States

Starting date: April 2011
Last updated: December 20, 2012