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Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)

A Phase 2, Double-blind, Randomized, Placebo-Controlled Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer

NCT00931606•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the percentage of participants in each sotatercept dose regimen who achieve a hematopoietic response during the treatment period including up to 2 months after the last dose of sotatercept treatment of chemotherapy-induced anemia (CIA) in participants with metastatic breast cancer. Hematopoietic response was defined as an increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of sotatercept in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA).

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Has a histologically confirmed diagnosis of breast cancer documented by cytology or biopsy.
•Has evidence of metastatic breast cancer with a minimum of one lesion per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v 1.1) criteria.
•Is receiving a chemotherapy regimen including one of the following: anthracycline, taxane, gemcitabine, vinorelbine or capecitabine.
•Has planned treatment with the same chemotherapy regimen for a minimum of 9 weeks after Day 1 of study intervention administration.
•≥ 30 days elapsed (from Day 1) since previous treatment with an erythropoiesis stimulating agent (ESA) (including treatment with intravenous (IV) iron) for chemotherapy induced anemia.
•≥ 7 days elapsed (from Day 1) since the last red blood cell (RBC) transfusion and receipt of ≤ 2 units of blood in the past 30 days.
•Life expectancy of ≥ 6 months.

Exclusion Criteria

•Has had prior radiation therapy to \> 20% of the whole skeleton.
•Has had \> 5 prior chemotherapy treatment regimens for metastatic breast cancer.
•Has a history of autoimmune or hereditary hemolysis or gastrointestinal bleeding.
•Has clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic or genitourinary disease unrelated to underlying hematologic disorder.
•Has heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher.
•Has a recent history of thrombosis, deep vein thrombosis (DVT), pulmonary emboli, or embolic stroke, occurring within the last 6 months.
•Has untreated central nervous system (CNS) metastases or CNS metastases treated with whole brain radiotherapy \< 6 months prior to Day 1.
•Has a diagnosis of a myeloid malignancy or known history of myelodysplasia.
•Has a history of second malignancy within 5 years (except excised and cured basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ).
•Has had administration of IV antibiotics or febrile (temperature elevation \> 38 ° C) within 14 days of Day 1.
+9 more criteria

Locations (35)

Investigative Site

Sedona, Arizona, United States

Investigative Site

Hot Springs, Arkansas, United States

Investigative Site

Beverly Hills, California, United States

Investigative Site

Corona, California, United States

Investigative Site

Fountain Valley, California, United States

Investigative Site

Montebello, California, United States

Investigative Site

Riverside, California, United States

Investigative Site

Denver, Colorado, United States

Investigative Site

Boynton Beach, Florida, United States

Investigative Site

Hinsdale, Illinois, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

November 18, 2010

Completion Date

November 18, 2010

Last Updated

September 13, 2023

Enrollment

ACTUAL participants

Conditions

Chemotherapy Induced Anemia

Interventions

Sotatercept

BIOLOGICAL

Placebo

DRUG

Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia

NCT01280240

Patients With Chemotherapy Induced Anemia (CIA)

View study

COMPLETEDPHASE3

A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

NCT00144482

Chemotherapy Induced Anemia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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