Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT01368003
Status:
WITHDRAWN
Last Update Posted:
2015-09-01
First Post:
2011-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling
Sponsor:
Toni Choueiri, MD
Organization:
Study Overview
Official Title:
A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Loss of funding.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: