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

Phase 2

Terminated

• Conditions: Solid Tumors
• Interventions: Drug: Sotatercept

• Registration Number: NCT01190644
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-01
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Primary Completion: 2012-09-18
• Study Completion: 2012-10-29
• Disposition First Submitted: 2014-01-30
• Disposition First Submitted QC: 2014-01-30
• Disposition First Posted: 2014-03-04
• Results First Submitted: 2023-07-12
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-09
• Last Update Submitted: 2023-11-09
• Results First Posted: 2023-11-29
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Men and women ≥18 years of age.
• Histologically confirmed diagnosis of a solid tumor malignancy documented by cytology or biopsy.
• Presence of metastatic disease.
• Hemoglobin value between ≥8.0 to <11.0 g/dL (≥80 to <110 g/L).
• ≥28 days must have elapsed (prior to pre-dose red blood cell mass / plasma volume test) since previous treatment with erythropoiesis-stimulating agent (including concurrent treatment with intravenous [IV] iron).
• ≥28 days must have elapsed (prior to Day 1) since the last red blood cell transfusion and receipt of ≤2 units of blood in the past 56 days (prior to Day 1).
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 1.

Exclusion Criteria

At the time of screening, participants who have any grade ≥3 toxicity (according to the currently active minor version of NCI CTCAE v4.0) except for the following disease-related toxicities:

• Hematological events - anemia, thrombocytopenia, neutropenia
• Non-hematological events - nausea, vomiting, fatigue, muscle or bone/joint pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (3)

Saint Agnes Healthcare; 🇺🇸 Baltimore, Maryland, United States

Weinberg Cancer Institution at Franklin Square; 🇺🇸 Baltimore, Maryland, United States

Pennsylvania Oncology; 🇺🇸 Philadelphia, Pennsylvania, United States