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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278993
Recruitment Status : Completed
First Posted : January 19, 2006
Results First Posted : May 15, 2012
Last Update Posted : July 14, 2014
Information provided by (Responsible Party):
Eisai Inc.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: E7389

  Participant Flow

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
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Reporting Groups
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 
Adverse Event                24 
Withdrawal by Subject                5 
Progressive Disease                65 
Physician Decision                9 
Not Otherwise Specified                4 

  Baseline Characteristics

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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 71.0  (9.36) 
[1] Intent to Treat/Safety Population
[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 

  Outcome Measures

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

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

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Eisai Inc. Identifier: NCT00278993     History of Changes
Other Study ID Numbers: E7389-G000-204
2005-004271-37 ( EudraCT Number )
First Submitted: January 17, 2006
First Posted: January 19, 2006
Results First Submitted: December 22, 2011
Results First Posted: May 15, 2012
Last Update Posted: July 14, 2014