A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
The primary objective is to determine whether STA-9090, or the combination with dutasteride further suppresses AR transcriptional activity. AR transcriptional activity will be assessed 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.
Toni K Choueiri, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|