Trial Outcomes & Findings for Study of Dalantercept and Sorafenib in Patients With Advanced Hepatocellular Carcinoma (NCT NCT02024087)
NCT ID: NCT02024087
Last Updated: 2022-09-26
Results Overview
Assessed by monitoring AEs using the current active minor version on the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 (NCI-CTCAE v4 current minor version), physical examinations, vital signs, clinical laboratory test, ECHO, ECG and ADA testing; through final study visit, up to approximately 20 weeks from first dose of dalantercept.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
up to approximately 20 weeks
Results posted on
2022-09-26
Participant Flow
First subject enrolled 04-AUG-2014 Last subject completed 05-JUL-2017 Study conducted at academic oncology centers in the US
Participant milestones
| Measure |
Dalantercept 0.6 mg/kg Plus Sorafenib 400 mg
Cohort 1: Participants were administered dalantercept 0.6 mg/kg by subcutaneous injection once every 3 weeks and sorafenib 400 mg orally once daily
|
Dalantercept 0.4 mg/kg Plus Sorafenib 400 mg
Cohort 2: Participants were administered dalantercept 0.4 mg/kg by subcutaneous injection once every 3 weeks and sorafenib 400 mg orally once daily
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
16
|
|
Overall Study
COMPLETED
|
5
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Dalantercept and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Dalantercept 0.6 mg/kg Plus Sorafenib 400 mg
n=5 Participants
Cohort 1: participants were administered dalantercept 0.6 mg/kg by subcutaneous injection once every 3 weeks plus sorafenib 400 mg orally once daily
|
Dalantercept 0.4 mg/kg Plus Sorafenib 400 mg
n=16 Participants
Cohort 2: participants were administered dalantercept 0.4 mg/kg by subcutaneous injection once every 3 weeks plus sorafenib 400 mg orally once daily
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
64.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
ECOG status
ECOG 1
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
ECOG status
ECOG 0
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to approximately 20 weeksAssessed by monitoring AEs using the current active minor version on the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 (NCI-CTCAE v4 current minor version), physical examinations, vital signs, clinical laboratory test, ECHO, ECG and ADA testing; through final study visit, up to approximately 20 weeks from first dose of dalantercept.
Outcome measures
| Measure |
Dalantercept 0.4 mg/kg Plus Sorafenib
n=16 Participants
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
Dalantercept 0.6 mg/kg Plus Sorafenib
n=5 Participants
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
|
16 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: up to approximately 20 weeksThe Best Overall Response (BOR) is the best response recorded from the start of the study treatment until the disease progression/recurrence, scored as one of the following: Complete Response (CR); Partial Response (PR); Stable Disease (SD) or Progressive Disease (PD). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), a CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD is defined as At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Dalantercept 0.4 mg/kg Plus Sorafenib
n=15 Participants
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
Dalantercept 0.6 mg/kg Plus Sorafenib
n=3 Participants
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
|---|---|---|
|
Best Overall Response
Complete response
|
0 Participants
|
0 Participants
|
|
Best Overall Response
Partial response
|
0 Participants
|
0 Participants
|
|
Best Overall Response
Stable disease
|
8 Participants
|
2 Participants
|
|
Best Overall Response
Progressive disease
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to approximately 20 weeksThe proportion of participants alive from the initiation of treatment through end of study
Outcome measures
| Measure |
Dalantercept 0.4 mg/kg Plus Sorafenib
n=16 Participants
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
Dalantercept 0.6 mg/kg Plus Sorafenib
n=5 Participants
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
|---|---|---|
|
Overall Survival (OS)
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to approximately 20 weeksPercentage of patients whose disease improves or remains stable over a certain time period. DCR is the sum of the complete, partial and stable disease rates.
Outcome measures
| Measure |
Dalantercept 0.4 mg/kg Plus Sorafenib
n=15 Participants
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
Dalantercept 0.6 mg/kg Plus Sorafenib
n=3 Participants
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
8 Participants
|
2 Participants
|
Adverse Events
Dalantercept 0.4 mg/kg Plus Sorafenib
Serious events: 6 serious events
Other events: 16 other events
Deaths: 9 deaths
Dalantercept 0.6 mg/kg Plus Sorafenib
Serious events: 4 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Dalantercept 0.4 mg/kg Plus Sorafenib
n=16 participants at risk
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
Dalantercept 0.6 mg/kg Plus Sorafenib
n=5 participants at risk
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
12.5%
2/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
40.0%
2/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
|
Cardiac disorders
atrial fibrillation
|
6.2%
1/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
20.0%
1/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
haemoptysis
|
6.2%
1/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
0.00%
0/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
6.2%
1/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
0.00%
0/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
|
Investigations
ejection fraction decrease
|
0.00%
0/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
20.0%
1/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
6.2%
1/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
0.00%
0/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
Other adverse events
| Measure |
Dalantercept 0.4 mg/kg Plus Sorafenib
n=16 participants at risk
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
Dalantercept 0.6 mg/kg Plus Sorafenib
n=5 participants at risk
Dalantercept plus sorafenib: Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
37.5%
6/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
20.0%
1/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
|
General disorders
peripheral oedema
|
25.0%
4/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
40.0%
2/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
0.00%
0/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
20.0%
1/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
|
Blood and lymphatic system disorders
leukopoenia
|
18.8%
3/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
20.0%
1/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
|
General disorders
asthenia
|
12.5%
2/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
0.00%
0/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
6.2%
1/16 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
0.00%
0/5 • Adverse event data were collection from the date of first patient enrollment to the end-of study visit (approximately 20 weeks)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place