Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial

This study has been completed.
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
First received: July 15, 2008
Last updated: April 2, 2014
Last verified: April 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
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
Lenalidomide lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle

Participant Flow:   Overall Study
STARTED     41  
COMPLETED     40  
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.
Patients with advanced hepatocellular cancer

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

Baseline Measures
Number of Participants  
[units: participants]
Age [1]
[units: years]
Median ( Full Range )
  ( 17 to 88 )  
[units: participants]
<=18 years     1  
Between 18 and 65 years     25  
>=65 years     14  
[units: participants]
Female     6  
Male     34  
Region of Enrollment  
[units: participants]
United States     41  
[1] While 41 patients were enrolled to the study only 40 were treated and received drug. Therefore, the 40 treated is the number used for assessments. However, baseline information is provided for all 41 patients.

  Outcome Measures

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

  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
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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: April 2, 2014
Health Authority: United States: Food and Drug Administration