Participants will receive a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85.

single 35 mg SC dose of sotatercept on study Day 1, Day 43, and Day 85

Sotatercept

Medical Director

What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ACE-011) pharmacodynamic study, completed by two well-known experts in the red cell production field.

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

A Phase 2, Open-Label, Pharmacodynamic Study to Evaluate the Effect of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Subjects With Solid Tumors

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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.

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.

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.

Blood samples were collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in erythropoietin levels.

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.

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.

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.

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.

Merck Sharp & Dohme LLC

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.

Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.

Sotatercept 35 mg

Participants received a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Senior Vice President, Global Clinical Development

No data were collected for Change from Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept.

Change From Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept

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

Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept

No data were collected for Change from Baseline in Absolute Reticulocyte Count.

Change From Baseline in Absolute Reticulocyte Count

All participants who received at least one dose of study treatment and had data for Change from Baseline in Erythropoietin Levels

Change From Baseline in Erythropoietin Levels

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

Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept

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

Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept

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

Change From Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept

All participants who received at least one dose of study treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Solid Tumors	Sotatercept	18 Years -	Merck Sharp & Dohme LLC
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	Solid Tumors	Sotatercept	18 Years -	Merck Sharp & Dohme LLC

Spots Global Cancer Trial Database for red blood cell mass