Trial Outcomes & Findings for Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial (NCT NCT00717756)
NCT ID: NCT00717756
Last Updated: 2020-02-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
on average about every 2 months until progression, on average about 4 months.
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Lenalidomide
lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Lenalidomide
lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=40 Participants
lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
|
|---|---|
|
Age, Continuous
|
60.5 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: on average about every 2 months until progression, on average about 4 months.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.
Outcome measures
| Measure |
Lenalidomide
n=40 Participants
lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
|
|---|---|
|
Response Rate by Recist Criteria
|
6 participants
|
Adverse Events
Lenalidomide
Serious events: 18 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide
n=40 participants at risk
lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
|
|---|---|
|
Investigations
edema gr 3, lethargy gr 2, HGB gr 2, hypotension gr 2
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
vasovagal episode gr3
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
ascites gr3, Liver dysfunction gr 3, fatigue gr 3, dehydration gr 3, vomiting gr 2, constipation gr2
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
bilirubin gr4, ascites gr 3, hyponatremia gr 3, hyperk gr 3
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
non-blistering rash gr 3
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
increased confusion
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
muscle weakness gr3, myelosuppresion gr 3
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
bilirubin gr 3, right upper quad pain gr 2
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
n gr1, v gr1, d gr1, pain abd gr2, pain chest gr2, gastro viral gr2
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
fracture gr 2
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
syncope gr3
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
syncope gr3, enceph gr 5, liver failure gr 5, GI bleed gr 3, death gr 5
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
hepatic enceph gr 3, mood alteration gr 2, mental status change gr 3
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
lower chest pressure
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
dizziness gr 3, dyspnea gr2, tumor pain gr 3, dehydration gr 3, confusion gr 1
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
bronchitis, pleural effusion, dyspnea, lower extrem edema, rash
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
fever gr 2, chills gr 2, bilary obstruction gr2, sepsis gr 2
|
2.5%
1/40 • Number of events 1 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
expired secondary to disease
|
27.5%
11/40 • Number of events 11 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
Other adverse events
| Measure |
Lenalidomide
n=40 participants at risk
lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
|
|---|---|
|
Investigations
alk phos
|
10.0%
4/40 • Number of events 4 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
alopecia
|
7.5%
3/40 • Number of events 3 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
ALT /AST
|
17.5%
7/40 • Number of events 7 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
ANC
|
15.0%
6/40 • Number of events 6 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
anemia
|
15.0%
6/40 • Number of events 6 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
anorexia
|
10.0%
4/40 • Number of events 4 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
ascites
|
5.0%
2/40 • Number of events 2 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
Ca
|
7.5%
3/40 • Number of events 3 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
constipation
|
20.0%
8/40 • Number of events 8 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
diarrhea
|
12.5%
5/40 • Number of events 5 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
diverticulitis
|
5.0%
2/40 • Number of events 2 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
dyspepsia
|
7.5%
3/40 • Number of events 3 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
edema
|
10.0%
4/40 • Number of events 4 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
esophageal stricture
|
5.0%
2/40 • Number of events 2 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
fatigue
|
32.5%
13/40 • Number of events 13 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
gastritis
|
5.0%
2/40 • Number of events 2 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
hyperglycemia
|
10.0%
4/40 • Number of events 4 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
HCT
|
10.0%
4/40 • Number of events 4 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
hemorrhoids
|
5.0%
2/40 • Number of events 2 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
Hyperbili
|
15.0%
6/40 • Number of events 6 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
hyperalbumin
|
5.0%
2/40 • Number of events 2 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
Hypoalbumin
|
12.5%
5/40 • Number of events 5 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
Hypokalemia
|
7.5%
3/40 • Number of events 3 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
Hypomagnesium
|
7.5%
3/40 • Number of events 3 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
hyponatremia
|
17.5%
7/40 • Number of events 7 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
infection-abdomen
|
5.0%
2/40 • Number of events 2 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
lymphopenia
|
7.5%
3/40 • Number of events 3 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
nausea
|
12.5%
5/40 • Number of events 5 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
neuropathy
|
10.0%
4/40 • Number of events 4 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
pain-abdomen
|
12.5%
5/40 • Number of events 5 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
pain-extremeties
|
10.0%
4/40 • Number of events 4 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
Pain-general/tumor
|
20.0%
8/40 • Number of events 8 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
puritis
|
12.5%
5/40 • Number of events 5 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
rash
|
27.5%
11/40 • Number of events 11 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
thrmbocytopenia
|
30.0%
12/40 • Number of events 12 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
URI
|
7.5%
3/40 • Number of events 3 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
|
Investigations
WBC
|
20.0%
8/40 • Number of events 8 • From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place