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A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy
Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090 works in treating patients with metastatic hormone-resistant prostate cancer previously treated 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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Medicine nd Denistry of New Jersey
Piscataway, New Jersey, United States
University of Wisconsin Cancer Center Riverview
Wisconsin Rapids, Wisconsin, United States
Start Date
January 1, 2011
Primary Completion Date
July 1, 2014
Completion Date
July 1, 2014
Last Updated
September 18, 2018
18
ACTUAL participants
Hsp90 inhibitor STA-9090
DRUG
laboratory biomarker analysis
OTHER
polymerase chain reaction
GENETIC
enzyme-linked immunosorbent assay
OTHER
RNA analysis
GENETIC
spectrophotometry
OTHER
reverse transcriptase-polymerase chain reaction
GENETIC
gene expression analysis
GENETIC
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
NCT01953640
NCT02312557
Data Source & Attribution
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