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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01190644
• Other study ID #: 7962-016
• Secondary ID: ACE-011-ST-001
• Status: Terminated
• Phase: Phase 2
• Start date: June 1, 2010
• Est. completion date: October 29, 2012

Study information

• Verified date: November 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 29, 2012
• Est. primary completion date: September 18, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• Sotatercept
single 35 mg SC dose of sotatercept on study Day 1, Day 43, and Day 85

Locations

Country	Name	City	State
United States	Saint Agnes Healthcare	Baltimore	Maryland
United States	Weinberg Cancer Institution at Franklin Square	Baltimore	Maryland
United States	Pennsylvania Oncology	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cappellini MD, Porter J, Origa R, Forni GL, Voskaridou E, Galacteros F, Taher AT, Arlet JB, Ribeil JA, Garbowski M, Graziadei G, Brouzes C, Semeraro M, Laadem A, Miteva D, Zou J, Sung V, Zinger T, Attie KM, Hermine O. Sotatercept, a novel transforming growth factor beta ligand trap, improves anemia in beta-thalassemia: a phase II, open-label, dose-finding study. Haematologica. 2019 Mar;104(3):477-484. doi: 10.3324/haematol.2018.198887. Epub 2018 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28
Secondary	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.	Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28
Secondary	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.	Baseline (Day 1, pre-dose) and Day 211
Secondary	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.	Baseline (Day 1, pre-dose) and Day 211
Secondary	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.	Baseline (Day 1, pre-dose) and Day 29
Secondary	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.	Baseline (Day 1, pre-dose) and Day 29
Secondary	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.	Baseline (Day 1, pre-dose) and Day 29
Secondary	Number of Participants Who Experienced One or More Adverse Events (AEs)	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.	Up to approximately 7 months

External Links

•   Merck Clinical Trials Information