Study of E7389 in Patients With Advanced Solid Tumors

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: NCT00069264
Recruitment Status : Completed
First Posted : September 24, 2003
Results First Posted : December 20, 2011
Last Update Posted : December 20, 2011
Information provided by:
Eisai Inc.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Advanced Solid Tumors
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
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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 E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.

Participant Flow:   Overall Study
Adverse Event                3 
Progressive Disease                23 
Withdrawal by Subject                3 
Discon Therapy                3 

  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 E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 57.4  (11.29) 
[Units: Participants]
Female   21 
Male   11 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   8 
Not Hispanic or Latino   24 
Unknown or Not Reported   0 
Race (NIH/OMB) [1] 
[Units: Participants]
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   7 
White   16 
More than one race   0 
Unknown or Not Reported   8 
[1] Please note: 8 subjects in unknown category were Hispanic/Latino
Region of Enrollment 
[Units: Participants]
United States   32 

  Outcome Measures

1.  Primary:   Determination of the Maximum Tolerated Dose   [ Time Frame: 28 Days ]

  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: Dr. Peter Tarassoff
Organization: Eisai Inc.
phone: 888-422--4743 Identifier: NCT00069264     History of Changes
Other Study ID Numbers: E7389-A001-101
First Submitted: September 19, 2003
First Posted: September 24, 2003
Results First Submitted: November 16, 2011
Results First Posted: December 20, 2011
Last Update Posted: December 20, 2011