Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01270880|
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : April 14, 2015
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer||Drug: Hsp90 inhibitor STA-9090 Other: laboratory biomarker analysis Genetic: polymerase chain reaction Other: enzyme-linked immunosorbent assay Genetic: RNA analysis Other: spectrophotometry Genetic: reverse transcriptase-polymerase chain reaction Genetic: gene expression analysis||Phase 2|
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.
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.
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Hsp90 inhibitor STA-9090
Other Name: STA-9090
Other: laboratory biomarker analysis
Genetic: polymerase chain reaction
Other Name: PCR
Other: enzyme-linked immunosorbent assay
Other Name: ELISA
Genetic: RNA analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other Name: RT-PCR
Genetic: gene expression analysis
- PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy [ Time Frame: At 6 months ]Our primary objective was to determine the 6-month PFS rate by using a binary (yes/no) endpoint of 6 months of PFS. Treatment success was defined as achievement of at least 6 months of PFS. Patients who did not complete 6 months of ganetespib therapy for any reason (including death from any cause) were considered treatment failures and were recorded as not achieving the primary endpoint.
- Percentage Change in PSA [ Time Frame: From baseline to 12 weeks ]Percentage change in PSA from baseline.
- Overall Safety and Tolerability of STA-9090 [ Time Frame: Day 1, 8, and 15 of each course and at end of treatment ]Overall safety and tolerability of STA-9090 by total number of grade 3 adverse events
- OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy [ Time Frame: From first dose to death or the date last known alive ]Overall Survival (OS) in metastatic Castrate Resistant Prostate Cancer (CRPC) who have received prior docetaxel therapy using Kaplan-Meier method
- Association of PFS With PSA [ Time Frame: At 6 months ]Association of PFS with PSA using Cox PH regression model
- Potential Markers for Predicting Drug Response or Efficacy [ Time Frame: At baseline, day 1 of course 3, and end of treatment ]Potential markers for predicting drug response or efficacy : This is not a measurable outcome, but a possible entity for further study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270880
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21231|
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New Jersey|
|University of Medicine nd Denistry of New Jersey|
|Piscataway, New Jersey, United States, 08854|
|United States, Wisconsin|
|University of Wisconsin Cancer Center Riverview|
|Wisconsin Rapids, Wisconsin, United States, 54494|
|Principal Investigator:||Elisabeth Heath||Barbara Ann Karmanos Cancer Institute|