Spots Global Cancer Trial Database for Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
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Trial Identification
Brief Title: Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
Official Title: 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
Study ID: NCT00931606
Conditions
Study Description
Brief 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, , Russian Federation
Investigative Site, Moscow (1), , Russian Federation
Investigative Site, Moscow (2), , Russian Federation
Investigative Site, Nizhny Novgorod, , Russian Federation
Investigative Site, Nizhny Novograd (2), , Russian Federation
Investigative Site, Pyatigorsk, , Russian Federation
Investigative Site, St. Petersburg (1), , Russian Federation
Investigative Site, St. Petersburg (2), , Russian Federation
Investigative Site, St. Petersburg (3), , Russian Federation
Investigative Site, St. Petersburg (4), , Russian Federation
Investigative Site, Stavropol, , Russian Federation
Contact Details
Name: Medical Director
Affiliation: Merck Sharp and Dohme LLC
Role: STUDY_DIRECTOR
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