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Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00717756
Recruitment Status : Completed
First Posted : July 17, 2008
Results First Posted : April 3, 2014
Last Update Posted : July 11, 2014
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Information provided by (Responsible Party):
howard safran, Brown University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Liver Cancer
Intervention: Drug: lenalidomide

  Participant Flow

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

Participant Flow:   Overall Study
Withdrawal by Subject                1 

  Baseline Characteristics

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[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   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

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

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

Publications of Results:

Responsible Party: howard safran, Brown University Identifier: NCT00717756     History of Changes
Other Study ID Numbers: BrUOG-HC-212
Celgene # RV-HCC-PI- 0159 ( Other Identifier: brown university )
celgene ( Other Identifier: brown university )
First Submitted: July 15, 2008
First Posted: July 17, 2008
Results First Submitted: February 20, 2014
Results First Posted: April 3, 2014
Last Update Posted: July 11, 2014