Trial · NCT01190644
Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors
NCT01190644, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2023-11-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors. Trials, record NCT01190644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01190644
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors
- NCT number
- NCT01190644
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Solid Tumors
- Interventions
- Sotatercept
- First posted
- 2010-08-27
- Last updated
- 2023-11-29
- Results first posted
- 2023-11-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept | Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28 | Blood samples were to be collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in red blood cell mass following a single dose of sotatercept. |
| Secondary | Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept | Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28 | Blood samples were collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in plasma volume following a single dose of sotatercept. |
| Secondary | Change From Baseline in Absolute Reticulocyte Count | Baseline (Day 1, pre-dose) and Day 211 | Blood samples were to be collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in absolute reticulocyte count. |
| Secondary | Change From Baseline in Erythropoietin Levels | Baseline (Day 1, pre-dose) and Day 211 | Blood samples were collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in erythropoietin levels. |
| Secondary | Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept | Baseline (Day 1, pre-dose) and Day 29 | Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A following a single dose of sotatercept. |
| Secondary | Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept | Baseline (Day 1, pre-dose) and Day 29 | Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A2 following a single dose of sotatercept. |
| Secondary | Change From Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept | Baseline (Day 1, pre-dose) and Day 29 | Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype C following a single dose of sotatercept. |
| Secondary | Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 7 months | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept | Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28 | No data were collected for Change from Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept. | ||
| SECONDARY | Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept | Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28 | All participants who received at least one dose of study treatment and had data for Change from Baseline in Plasma Volume Following a Single Dose of Sotatercept | mL | MEAN |
| SECONDARY | Change From Baseline in Absolute Reticulocyte Count | Baseline (Day 1, pre-dose) and Day 211 | No data were collected for Change from Baseline in Absolute Reticulocyte Count. | ||
| SECONDARY | Change From Baseline in Erythropoietin Levels | Baseline (Day 1, pre-dose) and Day 211 | All participants who received at least one dose of study treatment and had data for Change from Baseline in Erythropoietin Levels | IU/L | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept | Baseline (Day 1, pre-dose) and Day 29 | All participants who received at least one dose of study treatment and had data for Change from Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept | Percentage of hemoglobin subtype A | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept | Baseline (Day 1, pre-dose) and Day 29 | All participants who received at least one dose of study treatment and had data for Change from Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept | Percentage of hemoglobin subtype A2 | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept | Baseline (Day 1, pre-dose) and Day 29 | All participants who received at least one dose of study treatment and had data for Change from Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept | Percentage of hemoglobin subtype C | MEAN |
| SECONDARY | Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 7 months | All participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept | Sotatercept | -239.50 | Standard Deviation 219.91 | mL | |
| Change From Baseline in Erythropoietin Levels | Sotatercept | 11.30 | Full Range 11.3 to 11.3 | IU/L | |
| Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept | Sotatercept | 0.0 | Full Range 0.0 to 0.0 | Percentage of hemoglobin subtype A | |
| Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept | Sotatercept | 0.0 | Full Range 0.0 to 0.0 | Percentage of hemoglobin subtype A2 | |
| Change From Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept | Sotatercept | 0.0 | Full Range 0.0 to 0.0 | Percentage of hemoglobin subtype C | |
| Number of Participants Who Experienced One or More Adverse Events (AEs) | Sotatercept | 4 | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sotatercept | 5 | |
| Overall Study | Treated | Sotatercept | 4 | |
| Overall Study | COMPLETED | Sotatercept | 2 | |
| Overall Study | NOT COMPLETED | Sotatercept | 3 |
Source ClinicalTrials.gov
Adverse events39
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 | ANAEMIA | Blood and lymphatic system disorders | Sotatercept 35 mg | 1 | 4 | 1 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Sotatercept 35 mg | 1 | 4 | 1 |
| other | MYOCARDIAL INFARCTION | Cardiac disorders | Sotatercept 35 mg | 1 | 4 | 1 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Sotatercept 35 mg | 1 | 4 | 1 |
| other | ASCITES | Gastrointestinal disorders | Sotatercept 35 mg | 1 | 4 | 1 |
| other | CONSTIPATION | Gastrointestinal disorders | Sotatercept 35 mg | 1 | 4 | 2 |
| other | GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Sotatercept 35 mg | 1 | 4 | 1 |
| other | NAUSEA | Gastrointestinal disorders | Sotatercept 35 mg | 1 | 4 | 1 |
| other | VOMITING | Gastrointestinal disorders | Sotatercept 35 mg | 3 | 4 | 3 |
| other | OEDEMA PERIPHERAL | General disorders | Sotatercept 35 mg | 2 | 4 | 2 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sotatercept 35 mg | 2 | 5 |
| Total, other adverse events | Sotatercept 35 mg | 4 | 4 |
| Total, serious adverse events | Sotatercept 35 mg | 3 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30337358 | BACKGROUND |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01190644
GET https://conductscience.org/api/trials/v1/NCT01190644/events?page=2