Phase I Clinical Study of E7389

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00326950
First received: May 16, 2006
Last updated: March 6, 2012
Last verified: March 2012
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: 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 1 center in Japan during the period of May 2006 to Jan 2008

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 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.

Participant Flow:   Overall Study
    E7389  
STARTED     15  
COMPLETED     14  
NOT COMPLETED     1  
Progressive Disease                 1  



  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 E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.

Baseline Measures
    E7389  
Number of Participants  
[units: participants]
  15  
Age  
[units: years]
Mean ± Standard Deviation
  58.1  ± 7.9  
Gender  
[units: participants]
 
Female     6  
Male     9  
Race (NIH/OMB) [1]
[units: 15]
 
American Indian or Alaska Native     0  
Asian     15  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     0  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
Japan     15  
[1] Subjects were Japanese



  Outcome Measures
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1.  Primary:   Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)   [ Time Frame: 3 weeks ]

2.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: 3 Weeks ]

3.  Secondary:   Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects.   [ Time Frame: 3 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


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. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00326950     History of Changes
Other Study ID Numbers: E7389-J081-105
Study First Received: May 16, 2006
Results First Received: November 16, 2011
Last Updated: March 6, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare