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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

Interventions

Sotatercept
Placebo

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:

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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