A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy
PRIMARY OBJECTIVES:
I. To evaluate progression-free survival (PFS) achieved with STA-9090 (Hsp90 inhibitor
STA-9090) in men with castration-resistant prostate cancer (CRPC) who have received prior
docetaxel based therapy.
SECONDARY OBJECTIVES:
I. To assess the percentage change in prostate-specific antigen (PSA) from baseline to 12
weeks.
II. To assess overall safety and tolerability of STA-9090. III. To evaluate overall survival
(OS) outcome in metastatic CRPC who have received prior docetaxel therapy.
IV. To investigate the association of progression-free survival (PFS) and PSA response rate
with primary and secondary target markers.
TERTIARY OBJECTIVES:
I. To evaluate potential markers for predicting drug response or efficacy, blood samples
will be used to collect the serum and extract messenger ribonucleic acid (mRNA) from
mononuclear cells and analyzed by quantitative real-time polymerase chain reaction (PCR)
and/or enzyme-linked immunosorbent assay (ELISA).
OUTLINE:
Patients receive Hsp90 inhibitor STA-9090 intravenously (IV) over 1 hour once weekly in
weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PFS proportion achieved with STA-9090 in men with CRPC who have received prior docetaxel based therapy
Defined as the time from first dose until the patient demonstrates disease progression based on PSA changes, discontinues STA-9090 therapy (for any reason), or expires (from any cause), whichever occurs first. Estimated with the standard Kaplan-Meier (K-M) method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived.
At 6 months
No
Elisabeth Heath
Principal Investigator
Karmanos Cancer Institute
United States: Food and Drug Administration
2010-070
NCT01270880
January 2011
Name | Location |
---|---|
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital | Baltimore, Maryland 21231 |
University of Wisconsin Cancer Center Riverview | Wisconsin Rapids, Wisconsin 54494 |
University of Medicine nd Denistry of New Jersey | Piscataway, New Jersey 08854 |