Study of E7389 Administered Once Every 3 Weeks In Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00069277
First received: September 19, 2003
Last updated: April 6, 2012
Last verified: April 2012
Results First Received: January 9, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: 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 2 centers in U.S.during the period of Aug 2003 to Apr 2005.

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 Dose-Escalating E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.

Participant Flow:   Overall Study
    E7389 Dose-Escalating  
STARTED     21  
COMPLETED     0  
NOT COMPLETED     21  
Adverse Event                 3  
Withdrawal by Subject                 1  
Progressive Disease                 15  
Physician Decision                 2  



  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 Dose-Escalating E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.

Baseline Measures
    E7389 Dose-Escalating  
Number of Participants  
[units: participants]
  21  
Age, Customized  
[units: participants]
Mean ± Standard Deviation
 
Mean (+/- Standard Deviation)     59.0  ± 11.2  
Gender  
[units: participants]
 
Female     8  
Male     13  
Race/Ethnicity, Customized  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     16  
More than one race     0  
Unknown or Not Reported     0  
Hispanic/Latino     3  



  Outcome Measures

1.  Primary:   Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used.   [ Time Frame: 12 Weeks ]


  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 Call Center
Organization: Eisai Inc
phone: 888-422-4743


No publications provided


Responsible Party: Dale Shuster, Ph.D, Eisai Medical Research
ClinicalTrials.gov Identifier: NCT00069277     History of Changes
Other Study ID Numbers: E7389-A001-102
Study First Received: September 19, 2003
Results First Received: January 9, 2012
Last Updated: April 6, 2012
Health Authority: United States: Food and Drug Administration