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HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)

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ClinicalTrials.gov Identifier: NCT01849588
Recruitment Status : Terminated (Slow Accrual)
First Posted : May 8, 2013
Results First Posted : March 13, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew X. Zhu, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatocellular Cancer
Intervention Drug: Sorafenib
Enrollment 3
Recruitment Details Participants were enrolled between December 2013 and December 2015
Pre-assignment Details  
Arm/Group Title Sorafenib
Hide Arm/Group Description

Sorafenib taken orally twice per day

Sorafenib

Period Title: Overall Study
Started 3
Completed 0
Not Completed 3
Reason Not Completed
Lack of Efficacy             3
Arm/Group Title Sorafenib
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Sorafenib taken orally twice per day

Sorafenib

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
57.8
(56.9 to 61.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Decline in HCV-RNA Level
Hide Description Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement.
Time Frame up to 2 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
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Sorafenib taken orally twice per day

Sorafenib

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Time to Radiological Tumor Progression
Hide Description Time to radiological tumor progression is defined as the time period between enrollment and the earlier of tumor progression and death. Participants who are alive and progression-free at the date of last contact will be censored at this date.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual.
Arm/Group Title Treatment Arm
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Sorafenib taken orally twice per day

Sorafenib

Overall Number of Participants Analyzed 3
Mean (Full Range)
Unit of Measure: months
5.68
(1.84 to 12.43)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time period between enrollment and the date of death. Participants who are still alive at last contact will be censored at this date.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
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Sorafenib taken orally twice per day

Sorafenib

Overall Number of Participants Analyzed 3
Mean (Full Range)
Unit of Measure: months
8.36
(2.76 to 13.65)
4.Other Pre-specified Outcome
Title Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline
Hide Description The proportion of participants with a decrease of greater than 20% in AFP (alpha-fetoprotein) level between baseline and any subsequent measurement following treatment with sorafenib will be reported.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
AFP levels were not available for one participant.
Arm/Group Title Treatment Arm
Hide Arm/Group Description:

Sorafenib taken orally twice per day

Sorafenib

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Adverse Event Reporting Description Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
 
Arm/Group Title Sorafenib
Hide Arm/Group Description

Sorafenib taken orally twice per day

Sorafenib

All-Cause Mortality
Sorafenib
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Sorafenib
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sorafenib
Affected / at Risk (%)
Total   3/3 (100.00%) 
Blood and lymphatic system disorders   
anemia * 1  2/3 (66.67%) 
Gastrointestinal disorders   
diarrhea * 1  3/3 (100.00%) 
nausea * 1  2/3 (66.67%) 
GI bleed * 1  1/3 (33.33%) 
vomiting * 1  1/3 (33.33%) 
abdominal pain * 1  1/3 (33.33%) 
bloating * 1  2/3 (66.67%) 
ascites * 1  1/3 (33.33%) 
dyspepsia * 1  1/3 (33.33%) 
periodontal disease * 1 [1]  1/3 (33.33%) 
General disorders   
fatigue * 1  2/3 (66.67%) 
chills * 1  1/3 (33.33%) 
non-cardiac chest pain * 1  1/3 (33.33%) 
Investigations   
platelet count decreased * 1  3/3 (100.00%) 
elevated bilirubin * 1  3/3 (100.00%) 
elevated alkaline phosphatase * 1  3/3 (100.00%) 
weight loss * 1  1/3 (33.33%) 
SGOT increased * 1  3/3 (100.00%) 
SGPT increased * 1  2/3 (66.67%) 
Metabolism and nutrition disorders   
anorexia * 1  1/3 (33.33%) 
low phosphorus * 1  3/3 (100.00%) 
hyperglycemia * 1  2/3 (66.67%) 
hyperkalemia * 1  1/3 (33.33%) 
hypoalbuminemia * 1  1/3 (33.33%) 
hypocalcemia * 1  1/3 (33.33%) 
hypoglycemia * 1  1/3 (33.33%) 
hypomagnesemia * 1  1/3 (33.33%) 
hyponatremia * 1  1/3 (33.33%) 
Nervous system disorders   
headache * 1  1/3 (33.33%) 
Psychiatric disorders   
anxiety * 1  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders   
epistaxis * 1  1/3 (33.33%) 
Hoarseness * 1  1/3 (33.33%) 
Skin and subcutaneous tissue disorders   
palmar-plantar erythrodysesthesia * 1  2/3 (66.67%) 
erythema * 1  1/3 (33.33%) 
facial rash * 1  1/3 (33.33%) 
pruritis * 1  1/3 (33.33%) 
Vascular disorders   
hypertension * 1  1/3 (33.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
gum bleeding
Study was terminated early due to slow accrual, therefore a small number of participants were analyzed and the data are not statistically significant.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Andrew Zhu
Organization: Massachusetts General Hospital
Phone: 617-724-4000
EMail: azhu@partners.org
Layout table for additonal information
Responsible Party: Andrew X. Zhu, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01849588    
Other Study ID Numbers: 12-213
First Submitted: May 6, 2013
First Posted: May 8, 2013
Results First Submitted: January 23, 2017
Results First Posted: March 13, 2017
Last Update Posted: April 19, 2017