Trial Outcomes & Findings for 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 NCT01190644)
NCT ID: NCT01190644
Last Updated: 2023-11-29
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28
Results posted on
2023-11-29
Participant Flow
Participant milestones
| Measure |
Sotatercept
Participants received a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
Treated
|
4
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Sotatercept
Participants received a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85.
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|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Disease progression
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Sotatercept
n=5 Participants
Participants received a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85.
|
|---|---|
|
Age, Continuous
|
63.8 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28Population: No data were collected for Change from Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28Population: 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
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.
Outcome measures
| Measure |
Sotatercept
n=2 Participants
Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
|
|---|---|
|
Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept
|
-239.50 mL
Standard Deviation 219.91
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 211Population: No data were collected for Change from Baseline in Absolute Reticulocyte Count.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 211Population: All participants who received at least one dose of study treatment and had data for Change from Baseline in Erythropoietin Levels
Blood samples were collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in erythropoietin levels.
Outcome measures
| Measure |
Sotatercept
n=1 Participants
Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
|
|---|---|
|
Change From Baseline in Erythropoietin Levels
|
11.30 IU/L
Interval 11.3 to 11.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 29Population: 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
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.
Outcome measures
| Measure |
Sotatercept
n=1 Participants
Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
|
|---|---|
|
Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept
|
0.0 Percentage of hemoglobin subtype A
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 29Population: 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
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.
Outcome measures
| Measure |
Sotatercept
n=1 Participants
Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
|
|---|---|
|
Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept
|
0.0 Percentage of hemoglobin subtype A2
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 29Population: 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
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.
Outcome measures
| Measure |
Sotatercept
n=1 Participants
Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
|
|---|---|
|
Change From Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept
|
0.0 Percentage of hemoglobin subtype C
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to approximately 7 monthsPopulation: All participants who received at least one dose of study treatment.
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.
Outcome measures
| Measure |
Sotatercept
n=4 Participants
Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
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|---|---|
|
Number of Participants Who Experienced One or More Adverse Events (AEs)
|
4 Participants
|
Adverse Events
Sotatercept 35 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Sotatercept 35 mg
n=4 participants at risk
Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
|
|---|---|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
25.0%
1/4 • Number of events 2 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
PNEUMOPERITONEUM
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
DEVICE DISLOCATION
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
INFECTED SKIN ULCER
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
25.0%
1/4 • Number of events 2 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
Other adverse events
| Measure |
Sotatercept 35 mg
n=4 participants at risk
Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
ASCITES
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.0%
1/4 • Number of events 2 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
NAUSEA
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Gastrointestinal disorders
VOMITING
|
75.0%
3/4 • Number of events 3 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
General disorders
OEDEMA PERIPHERAL
|
50.0%
2/4 • Number of events 2 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
ESCHERICHIA INFECTION
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
NASOPHARYNGITIS
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
25.0%
1/4 • Number of events 2 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
25.0%
1/4 • Number of events 2 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Nervous system disorders
HEADACHE
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Psychiatric disorders
ANXIETY
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Psychiatric disorders
INSOMNIA
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Vascular disorders
HYPERTENSION
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
|
Vascular disorders
HYPOTENSION
|
25.0%
1/4 • Number of events 1 • Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
|
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 The sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the sponsor will generally support publication.
- Publication restrictions are in place
Restriction type: OTHER