Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
NCT ID: NCT00931606
Last Updated: 2023-09-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2009-06-01
2010-11-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014)
NCT00106145
Sorafenib in Treating Patients With Metastatic Breast Cancer
NCT00096434
Lapatinib Ditosylate and Akt Inhibitor MK2206 in Treating Women With Metastatic Breast Cancer
NCT01281163
PTC299 and Hormonal Agent for Treatment of Metastatic Breast Cancer
NCT00508586
Clinical Trial of SAHA in Patients With Breast Cancer
NCT00416130
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sotatercept 0.1 mg/kg
Participants will receive sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
Sotatercept
up to 4 subcutaneous doses of sotatercept given once every 28 days
Sotatercept 0.3 mg/kg
Participants will receive sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
Sotatercept
up to 4 subcutaneous doses of sotatercept given once every 28 days
Sotatercept 0.5 mg/kg
Participants will receive sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Sotatercept
up to 4 subcutaneous doses of sotatercept given once every 28 days
Placebo
Participants will receive placebo subcutaneously every 28 days up to 4 doses.
Placebo
up to 4 subcutaneous doses of placebo given once every 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sotatercept
up to 4 subcutaneous doses of sotatercept given once every 28 days
Placebo
up to 4 subcutaneous doses of placebo given once every 28 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 \> 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.
* Has uncontrolled hypertension.
* Has known history of hepatitis B surface antigen (HBsAg and HB core antibody (Ab)), human immunodeficiency virus (HIV) antibody or active hepatitis C.
* Has clinically significant iron (transferrin saturation \< 20%), vitamin B12, or folate deficiency.
* Has a history of anemia as a result of inherited hemoglobinopathy such as sickle cell anemia or thalassemia.
* Has a history of autoimmune or hereditary hemolysis; active gastrointestinal bleeding (within the last 6 months as compared to Day 1).
* Has received treatment with another investigational drug or device within 1 month prior to Day 1.
* Is pregnant or lactating.
* Has a history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product.
* Has had major surgery within 30 days prior to Day 1 (patients must have completely recovered from any previous surgery prior to Day 1).
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp and Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Investigative Site
Evansville, Indiana, United States
Investigative Site
Wichita, Kansas, United States
Investigative Site
Baltimore, Maryland, United States
Investigative Site
Grand Rapids, Michigan, United States
Investigative Site
Tupelo, Mississippi, United States
Investigative Site
Kansas City, Missouri, United States
Investigative Site
Nyack, New York, United States
Investigative Site
Goldsboro, North Carolina, United States
Investigative Site
High Point, North Carolina, United States
Investigative Site
Winston-Salem, North Carolina, United States
Investigative Site
Bismarck, North Dakota, United States
Investigative Site
Middletown, Ohio, United States
Investigative Site
Philadelphia, Pennsylvania, United States
Investigative Site
Charleston, South Carolina, United States
Investigative Site
Austin, Texas, United States
Investigative Site
Dallas, Texas, United States
Investigative Site
Tyler, Texas, United States
Investigative Site
Lacey, Washington, United States
Investigative Site
Krasnodar, , Russia
Investigative Site
Moscow, , Russia
Investigative Site
Nizhny Novgorod, , Russia
Investigative Site
Nizhny Novograd (2), , Russia
Investigative Site
Pyatigorsk, , Russia
Investigative Site
Saint Petersburg, , Russia
Investigative Site
Stavropol, , Russia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Raftopoulos H, Laadem A, Hesketh PJ, Goldschmidt J, Gabrail N, Osborne C, Ali M, Sherman ML, Wang D, Glaspy JA, Puccio-Pick M, Zou J, Crawford J. Sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia in patients with metastatic breast cancer or advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens: results from two phase 2 studies. Support Care Cancer. 2016 Apr;24(4):1517-25. doi: 10.1007/s00520-015-2929-9. Epub 2015 Sep 14.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A011-08
Identifier Type: OTHER
Identifier Source: secondary_id
MK-7962-012
Identifier Type: OTHER
Identifier Source: secondary_id
7962-012
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.