NCT01368003

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Toni Choueiri, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
DRUG	STA9090	200 mg/m\^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)
DRUG	STA9090 with Dutasteride	Dutasteride 3.5 mg orally per day STA9090 200 mg/m\^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-06-07
• Last updated: 2015-09-01

Locations

2 sites across 1 country: United States