Trial · NCT02024087
Study of Dalantercept and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
NCT02024087, Phase 1, Phase 2, Completed, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA; results first posted 2020-12-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Dalantercept and Sorafenib in Patients With Advanced Hepatocellular Carcinoma. Trials, record NCT02024087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02024087
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dalantercept and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
- NCT number
- NCT02024087
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Conditions
- Advanced Adult Hepatocellular Carcinoma
- Interventions
- Dalantercept plus sorafenib
- First posted
- 2013-12-31
- Last updated
- 2022-09-26
- Results first posted
- 2020-12-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | up to approximately 20 weeks | 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. |
| Secondary | Best Overall Response | up to approximately 20 weeks | The 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. |
| Secondary | Overall Survival (OS) | up to approximately 20 weeks | The proportion of participants alive from the initiation of treatment through end of study |
| Secondary | Disease Control Rate (DCR) | up to approximately 20 weeks | Percentage 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | up to approximately 20 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Best Overall Response | up to approximately 20 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival (OS) | up to approximately 20 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease Control Rate (DCR) | up to approximately 20 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | Dalantercept 0.4 mg/kg Plus Sorafenib | 16 | Participants | ||
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | Dalantercept 0.6 mg/kg Plus Sorafenib | 5 | Participants | ||
| Best Overall Response | Dalantercept 0.4 mg/kg Plus Sorafenib | Complete response | 0 | Participants | |
| Best Overall Response | Dalantercept 0.6 mg/kg Plus Sorafenib | Complete response | 0 | Participants | |
| Best Overall Response | Dalantercept 0.4 mg/kg Plus Sorafenib | Partial response | 0 | Participants | |
| Best Overall Response | Dalantercept 0.6 mg/kg Plus Sorafenib | Partial response | 0 | Participants | |
| Best Overall Response | Dalantercept 0.4 mg/kg Plus Sorafenib | Stable disease | 8 | Participants | |
| Best Overall Response | Dalantercept 0.6 mg/kg Plus Sorafenib | Stable disease | 2 | Participants | |
| Best Overall Response | Dalantercept 0.4 mg/kg Plus Sorafenib | Progressive disease | 7 | Participants | |
| Best Overall Response | Dalantercept 0.6 mg/kg Plus Sorafenib | Progressive disease | 1 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dalantercept 0.6 mg/kg Plus Sorafenib 400 mg | 5 | |
| Overall Study | STARTED | Dalantercept 0.4 mg/kg Plus Sorafenib 400 mg | 16 | |
| Overall Study | COMPLETED | Dalantercept 0.6 mg/kg Plus Sorafenib 400 mg | 5 | |
| Overall Study | COMPLETED | Dalantercept 0.4 mg/kg Plus Sorafenib 400 mg | 16 | |
| Overall Study | NOT COMPLETED | Dalantercept 0.6 mg/kg Plus Sorafenib 400 mg | 0 | |
| Overall Study | NOT COMPLETED | Dalantercept 0.4 mg/kg Plus Sorafenib 400 mg | 0 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | abdominal pain | Gastrointestinal disorders | Dalantercept 0.4 mg/kg Plus Sorafenib | 6 | 16 | |
| other | abdominal pain | Gastrointestinal disorders | Dalantercept 0.6 mg/kg Plus Sorafenib | 1 | 5 | |
| other | peripheral oedema | General disorders | Dalantercept 0.4 mg/kg Plus Sorafenib | 4 | 16 | |
| other | peripheral oedema | General disorders | Dalantercept 0.6 mg/kg Plus Sorafenib | 2 | 5 | |
| other | pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Dalantercept 0.4 mg/kg Plus Sorafenib | 0 | 16 | |
| other | pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Dalantercept 0.6 mg/kg Plus Sorafenib | 1 | 5 | |
| other | leukopoenia | Blood and lymphatic system disorders | Dalantercept 0.4 mg/kg Plus Sorafenib | 3 | 16 | |
| other | leukopoenia | Blood and lymphatic system disorders | Dalantercept 0.6 mg/kg Plus Sorafenib | 1 | 5 | |
| other | asthenia | General disorders | Dalantercept 0.4 mg/kg Plus Sorafenib | 2 | 16 | |
| other | asthenia | General disorders | Dalantercept 0.6 mg/kg Plus Sorafenib | 0 | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalantercept 0.4 mg/kg Plus Sorafenib | 9 | 16 |
| Total, all-cause mortality | Dalantercept 0.6 mg/kg Plus Sorafenib | 5 | 5 |
| Total, other adverse events | Dalantercept 0.4 mg/kg Plus Sorafenib | 16 | 16 |
| Total, other adverse events | Dalantercept 0.6 mg/kg Plus Sorafenib | 5 | 5 |
| Total, serious adverse events | Dalantercept 0.4 mg/kg Plus Sorafenib | 6 | 16 |
| Total, serious adverse events | Dalantercept 0.6 mg/kg Plus Sorafenib | 4 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30352941 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dalantercept 0.4 mg/kg Plus Sorafenib vs Dalantercept 0.6 mg/kg Plus Sorafenib: Overall Survival (OS) | Trial comparisons |
| Dalantercept 0.4 mg/kg Plus Sorafenib vs Dalantercept 0.6 mg/kg Plus Sorafenib: Disease Control Rate (DCR) | Trial comparisons |
| Dalantercept 0.4 mg/kg Plus Sorafenib vs Dalantercept 0.6 mg/kg Plus Sorafenib: deaths from any cause | Trial comparisons |
| Dalantercept 0.4 mg/kg Plus Sorafenib vs Dalantercept 0.6 mg/kg Plus Sorafenib: Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | Trial comparisons |
| Dalantercept 0.4 mg/kg Plus Sorafenib vs Dalantercept 0.6 mg/kg Plus Sorafenib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02024087
GET https://conductscience.org/api/trials/v1/NCT02024087/events?page=2