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

Toni Choueiri, MD

Status and phase

Withdrawn

Phase 2

Conditions

Adenocarcinoma of the Prostate

Treatments

Drug: STA9090 with Dutasteride

Drug: STA9090

Study type

Interventional

Funder types

Other

Identifiers

NCT01368003

10-333

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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