Trial Outcomes & Findings for HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC) (NCT NCT01849588)
NCT ID: NCT01849588
Last Updated: 2017-04-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
up to 2 years
Results posted on
2017-04-19
Participant Flow
Participants were enrolled between December 2013 and December 2015
Participant milestones
| Measure |
Sorafenib
Sorafenib taken orally twice per day
Sorafenib
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Sorafenib
Sorafenib taken orally twice per day
Sorafenib
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
Baseline Characteristics
HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)
Baseline characteristics by cohort
| Measure |
Sorafenib
n=3 Participants
Sorafenib taken orally twice per day
Sorafenib
|
|---|---|
|
Age, Continuous
|
57.8 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsSuccessful 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.
Outcome measures
| Measure |
Treatment Arm
n=3 Participants
Sorafenib taken orally twice per day
Sorafenib
|
|---|---|
|
Decline in HCV-RNA Level
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Study was terminated early due to slow accrual.
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.
Outcome measures
| Measure |
Treatment Arm
n=3 Participants
Sorafenib taken orally twice per day
Sorafenib
|
|---|---|
|
Time to Radiological Tumor Progression
|
5.68 months
Interval 1.84 to 12.43
|
SECONDARY outcome
Timeframe: 2 yearsOverall 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.
Outcome measures
| Measure |
Treatment Arm
n=3 Participants
Sorafenib taken orally twice per day
Sorafenib
|
|---|---|
|
Overall Survival
|
8.36 months
Interval 2.76 to 13.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: AFP levels were not available for one participant.
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.
Outcome measures
| Measure |
Treatment Arm
n=2 Participants
Sorafenib taken orally twice per day
Sorafenib
|
|---|---|
|
Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline
|
0 Participants
|
Adverse Events
Sorafenib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sorafenib
n=3 participants at risk
Sorafenib taken orally twice per day
Sorafenib
|
|---|---|
|
Gastrointestinal disorders
diarrhea
|
100.0%
3/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
General disorders
fatigue
|
66.7%
2/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Skin and subcutaneous tissue disorders
palmar-plantar erythrodysesthesia
|
66.7%
2/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Gastrointestinal disorders
nausea
|
66.7%
2/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Investigations
platelet count decreased
|
100.0%
3/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Metabolism and nutrition disorders
anorexia
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Skin and subcutaneous tissue disorders
erythema
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Gastrointestinal disorders
GI bleed
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Metabolism and nutrition disorders
low phosphorus
|
100.0%
3/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Investigations
elevated bilirubin
|
100.0%
3/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Investigations
elevated alkaline phosphatase
|
100.0%
3/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Vascular disorders
hypertension
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Skin and subcutaneous tissue disorders
facial rash
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Gastrointestinal disorders
vomiting
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Investigations
weight loss
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Gastrointestinal disorders
abdominal pain
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Gastrointestinal disorders
bloating
|
66.7%
2/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Blood and lymphatic system disorders
anemia
|
66.7%
2/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Psychiatric disorders
anxiety
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Gastrointestinal disorders
ascites
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
General disorders
chills
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Gastrointestinal disorders
dyspepsia
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Gastrointestinal disorders
periodontal disease
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Nervous system disorders
headache
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
66.7%
2/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Metabolism and nutrition disorders
hyponatremia
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
General disorders
non-cardiac chest pain
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
33.3%
1/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Investigations
SGOT increased
|
100.0%
3/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
|
Investigations
SGPT increased
|
66.7%
2/3 • Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place