Study of E7389 in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00069264
First received: September 19, 2003
Last updated: November 16, 2011
Last verified: November 2011
Results First Received: November 16, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Advanced Solid Tumors
Intervention: Drug: E7389

  Participant Flow
  Hide Participant Flow

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
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
    E7389  
STARTED     32  
COMPLETED     0  
NOT COMPLETED     32  
Adverse Event                 3  
Progressive Disease                 23  
Withdrawal by Subject                 3  
Discon Therapy                 3  



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
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
    E7389  
Number of Participants  
[units: participants]
  32  
Age  
[units: years]
Mean ± Standard Deviation
  57.4  ± 11.29  
Gender  
[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  
Region of Enrollment  
[units: participants]
 
United States     32  
[1] Please note: 8 subjects in unknown category were Hispanic/Latino



  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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


No publications provided


ClinicalTrials.gov Identifier: NCT00069264     History of Changes
Other Study ID Numbers: E7389-A001-101, E7389, BOLD
Study First Received: September 19, 2003
Results First Received: November 16, 2011
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration