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Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00278993
First received: January 17, 2006
Last updated: June 30, 2014
Last verified: April 2012
Results First Received: December 22, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: E7389

  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
This study was recruited at 22 centers in U.S, UK, Spain and Hungary during the period of Feb 2006 to May 2009.

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
E7389 Intravenous 1.4 mg/m2 E7389 intravenous 1.4 mg/m2 on a 3-week course

Participant Flow:   Overall Study
    E7389 Intravenous 1.4 mg/m2  
STARTED     108  
COMPLETED     1  
NOT COMPLETED     107  
Adverse Event                 24  
Withdrawal by Subject                 5  
Progressive Disease                 65  
Physician Decision                 9  
Not Otherwise Specified                 4  



  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
E7389 Intravenous 1.4 mg/m2 E7389 intravenous 1.4 mg/m2 on a 3-week course

Baseline Measures
    E7389 Intravenous 1.4 mg/m2  
Number of Participants  
[units: participants]
  108  
Age [1]
[units: years]
Mean ± Standard Deviation
  71.0  ± 9.36  
Gender  
[units: participants]
 
Female     0  
Male     108  
Race/Ethnicity, Customized  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     3  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     6  
White     94  
More than one race     0  
Other     5  
Unknown or Not Reported     0  
[1] Intent to Treat/Safety Population



  Outcome Measures
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1.  Primary:   Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria   [ Time Frame: 12 months ]

2.  Secondary:   Duration of Prostate Specific Antigen Response Based on Bubley Criteria   [ Time Frame: 12 months. ]

3.  Secondary:   Progression Free Survival   [ Time Frame: 12 months ]

4.  Secondary:   Overall Survival   [ Time Frame: 12 months ]

5.  Secondary:   Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria   [ Time Frame: 12 months ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743


No publications provided by Eisai Inc.

Publications automatically indexed to this study:

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00278993     History of Changes
Other Study ID Numbers: E7389-G000-204, 2005-004271-37
Study First Received: January 17, 2006
Results First Received: December 22, 2011
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration