An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00280397
First received: January 20, 2006
Last updated: March 16, 2015
Last verified: October 2014
Results First Received: February 21, 2015  
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: Solid Tumors
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
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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
E7080 Group E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.

Participant Flow:   Overall Study
    E7080 Group  
STARTED     27  
COMPLETED     26  
NOT COMPLETED     1  
Adverse Event                 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 Group E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.

Baseline Measures
    E7080 Group  
Number of Participants  
[units: participants]
  27  
Age  
[units: Years]
Mean (Standard Deviation)
  50.7  (11.1)  
Gender, Customized  
[units: Participants]
 
Male     10  
Female     17  



  Outcome Measures
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1.  Primary:   Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day   [ Time Frame: up to 4 weeks ]

2.  Primary:   DLT of E7080 Repeatedly Administered Twice a Day   [ Time Frame: up to 4 weeks ]

3.  Secondary:   Number of Participants With Adverse Events / Serious Adverse Events   [ Time Frame: Until tumor progression, unacceptable toxicity, or withdrawal due to other reasons. ]

4.  Secondary:   To Elucidate the Pharmacokinetic Profile of E7080   [ Time Frame: Every 3 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Determine the Clinical Dose for Phase II Study Based on Safety and Pharmacokinetic Profile   [ Time Frame: Every 3 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Evaluate the Anti-tumor Activity of E7080   [ Time Frame: Every 3 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   To Make Exploratory Analyses of Pharmacodynamic Markers   [ Time Frame: Every 3 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Akihiko Tsuruoka
Organization: Eisai Co., Ltd.
phone: +81-3-3817-5252 ext 5252


No publications provided by Eisai Inc.

Publications automatically indexed to this study:

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00280397     History of Changes
Other Study ID Numbers: E7080-J081-103
Study First Received: January 20, 2006
Results First Received: February 21, 2015
Last Updated: March 16, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare