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Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial

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ClinicalTrials.gov Identifier: NCT00717756
Recruitment Status : Completed
First Posted : July 17, 2008
Results First Posted : April 3, 2014
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Information provided by (Responsible Party):
howard safran, Brown University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Cancer
Intervention Drug: lenalidomide
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide
Hide Arm/Group Description lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
Period Title: Overall Study
Started 41
Completed 40
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Lenalidomide
Hide Arm/Group Description lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
60.5
(17 to 88)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
1
   2.5%
Between 18 and 65 years
25
  62.5%
>=65 years
14
  35.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
6
  15.0%
Male
34
  85.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Response Rate by Recist Criteria
Hide Description

radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD

It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed.

Time Frame on average about every 2 months until progression, on average about 4 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
6
Time Frame From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%) # Events
Total   18/40 (45.00%)    
Investigations   
edema gr 3, lethargy gr 2, HGB gr 2, hypotension gr 2   1/40 (2.50%)  1
vasovagal episode gr3   1/40 (2.50%)  1
ascites gr3, Liver dysfunction gr 3, fatigue gr 3, dehydration gr 3, vomiting gr 2, constipation gr2   1/40 (2.50%)  1
bilirubin gr4, ascites gr 3, hyponatremia gr 3, hyperk gr 3   1/40 (2.50%)  1
non-blistering rash gr 3   1/40 (2.50%)  1
increased confusion   1/40 (2.50%)  1
muscle weakness gr3, myelosuppresion gr 3   1/40 (2.50%)  1
bilirubin gr 3, right upper quad pain gr 2   1/40 (2.50%)  1
n gr1, v gr1, d gr1, pain abd gr2, pain chest gr2, gastro viral gr2   1/40 (2.50%)  1
fracture gr 2   1/40 (2.50%)  1
syncope gr3   1/40 (2.50%)  1
syncope gr3, enceph gr 5, liver failure gr 5, GI bleed gr 3, death gr 5   1/40 (2.50%)  1
hepatic enceph gr 3, mood alteration gr 2, mental status change gr 3   1/40 (2.50%)  1
lower chest pressure   1/40 (2.50%)  1
dizziness gr 3, dyspnea gr2, tumor pain gr 3, dehydration gr 3, confusion gr 1   1/40 (2.50%)  1
bronchitis, pleural effusion, dyspnea, lower extrem edema, rash  [1]  1/40 (2.50%)  1
fever gr 2, chills gr 2, bilary obstruction gr2, sepsis gr 2   1/40 (2.50%)  1
expired secondary to disease   11/40 (27.50%)  11
Indicates events were collected by systematic assessment
[1]
Labs AEs with SAE: anemia, ammonia, AST, alk phos, sodium, K, chloride, mg, co2, anion gap, albumin, BNP, ca, PLT
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide
Affected / at Risk (%) # Events
Total   40/40 (100.00%)    
Investigations   
alk phos   4/40 (10.00%)  4
alopecia   3/40 (7.50%)  3
ALT /AST   7/40 (17.50%)  7
ANC   6/40 (15.00%)  6
anemia   6/40 (15.00%)  6
anorexia   4/40 (10.00%)  4
ascites   2/40 (5.00%)  2
Ca   3/40 (7.50%)  3
constipation   8/40 (20.00%)  8
diarrhea   5/40 (12.50%)  5
diverticulitis   2/40 (5.00%)  2
dyspepsia   3/40 (7.50%)  3
edema   4/40 (10.00%)  4
esophageal stricture   2/40 (5.00%)  2
fatigue   13/40 (32.50%)  13
gastritis   2/40 (5.00%)  2
hyperglycemia   4/40 (10.00%)  4
HCT   4/40 (10.00%)  4
hemorrhoids   2/40 (5.00%)  2
Hyperbili   6/40 (15.00%)  6
hyperalbumin   2/40 (5.00%)  2
Hypoalbumin   5/40 (12.50%)  5
Hypokalemia   3/40 (7.50%)  3
Hypomagnesium   3/40 (7.50%)  3
hyponatremia   7/40 (17.50%)  7
infection-abdomen   2/40 (5.00%)  2
lymphopenia   3/40 (7.50%)  3
nausea   5/40 (12.50%)  5
neuropathy   4/40 (10.00%)  4
pain-abdomen   5/40 (12.50%)  5
pain-extremeties   4/40 (10.00%)  4
Pain-general/tumor   8/40 (20.00%)  8
puritis   5/40 (12.50%)  5
rash   11/40 (27.50%)  11
thrmbocytopenia   12/40 (30.00%)  12
URI   3/40 (7.50%)  3
WBC   8/40 (20.00%)  8
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Howard Safran, MD
Organization: BrUOG
Phone: 4018633000
EMail: Hsafran@lifespan.org
Layout table for additonal information
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 ( 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: April 25, 2019