A Study of E7080 in Subjects With Solid Tumor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01268293
First received: December 28, 2010
Last updated: February 21, 2015
Last verified: February 2014
Results First Received: February 21, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer
Intervention: Drug: E7080

  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
No text entered.

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
  Description
E7080 E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.

Participant Flow:   Overall Study
    E7080  
STARTED     9  
Completed Cycle 1     9  
COMPLETED     0  
NOT COMPLETED     9  
Disease progression                 7  
Adverse Event                 1  
Subject choice                 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.
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Reporting Groups
  Description
E7080 E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.

Baseline Measures
    E7080  
Number of Participants  
[units: participants]
  9  
Age  
[units: Years]
Mean (Standard Deviation)
  43.6  (11.5)  
Gender, Customized  
[units: Participants]
 
Male     2  
Female     7  



  Outcome Measures
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1.  Primary:   Number of Participants With Dose Limiting Toxicity (DLT)   [ Time Frame: Up to 4 weeks ]

2.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days). ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Tatsuya Sasaki
Organization: Eisai Co., Ltd.
phone: 81-3-3817-5252 ext 5252


No publications provided


Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01268293     History of Changes
Other Study ID Numbers: E7080-J081-105
Study First Received: December 28, 2010
Results First Received: February 21, 2015
Last Updated: February 21, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare