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Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial

This study has been completed.
Sponsor:
Collaborators:
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT00717756
First received: July 15, 2008
Last updated: June 26, 2014
Last verified: June 2014
Results First Received: February 20, 2014  
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: Liver Cancer
Intervention: Drug: lenalidomide

  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
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Reporting Groups
  Description
Lenalidomide lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle

Participant Flow:   Overall Study
    Lenalidomide  
STARTED     41  
COMPLETED     40  
NOT COMPLETED     1  
Withdrawal by Subject                 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
Lenalidomide lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle

Baseline Measures
    Lenalidomide  
Number of Participants  
[units: participants]
  40  
Age  
[units: years]
Median ( Full Range )
  60.5  
  ( 17 to 88 )  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     25  
>=65 years     14  
Gender  
[units: participants]
 
Female     6  
Male     34  
Region of Enrollment  
[units: participants]
 
United States     40  



  Outcome Measures

1.  Primary:   Response Rate by Recist Criteria   [ Time Frame: on average about every 2 months until progression, on average about 4 months. ]


  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 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: Howard Safran, MD
Organization: BrUOG
phone: 4018633000
e-mail: Hsafran@lifespan.org


Publications of Results:

Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT00717756     History of Changes
Other Study ID Numbers: BrUOG-HC-212, Celgene # RV-HCC-PI- 0159, celgene
Study First Received: July 15, 2008
Results First Received: February 20, 2014
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration