Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elisabeth Heath, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01270880
First received: January 4, 2011
Last updated: April 1, 2015
Last verified: April 2015
Results First Received: April 1, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Interventions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Hsp90 inhibitor STA-9090: Given IV

laboratory biomarker analysis: Correlative studies

polymerase chain reaction: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

RNA analysis: Correlative studies

spectrophotometry: Correlative studies

reverse transcriptase-polymerase chain reaction: Correlative studies

gene expression analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Enzyme Inhibitor Therapy)  
STARTED     18  
COMPLETED     17  
NOT COMPLETED     1  
Never rec'd treatment, but registered.                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Hsp90 inhibitor STA-9090: Given IV

laboratory biomarker analysis: Correlative studies

polymerase chain reaction: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

RNA analysis: Correlative studies

spectrophotometry: Correlative studies

reverse transcriptase-polymerase chain reaction: Correlative studies

gene expression analysis: Correlative studies


Baseline Measures
    Treatment (Enzyme Inhibitor Therapy)  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Median ( Full Range )
  68  
  ( 51 to 82 )  
Gender  
[units: participants]
 
Female     0  
Male     18  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures

1.  Primary:   PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy   [ Time Frame: At 6 months ]

2.  Secondary:   Percentage Change in PSA   [ Time Frame: From baseline to 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Overall Safety and Tolerability of STA-9090   [ Time Frame: Day 1, 8, and 15 of each course and at end of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy   [ Time Frame: From first dose to death or the date last known alive ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Association of PFS and PSA Response Rate With Primary and Secondary Target Markers   [ Time Frame: At 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Potential Markers for Predicting Drug Response or Efficacy   [ Time Frame: At baseline, day 1 of course 3, and end of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Elisabeth I. Heath, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
phone: 313-576-8715
e-mail: heathe@karmanos.org


No publications provided


Responsible Party: Elisabeth Heath, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01270880     History of Changes
Other Study ID Numbers: 2010-070, NCI-2010-02328
Study First Received: January 4, 2011
Results First Received: April 1, 2015
Last Updated: April 1, 2015
Health Authority: United States: Food and Drug Administration