NCT00931606

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chemotherapy Induced Anemia

Interventions

Type	Name	Description
BIOLOGICAL	Sotatercept	up to 4 subcutaneous doses of sotatercept given once every 28 days
DRUG	Placebo	up to 4 subcutaneous doses of placebo given once every 28 days

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-11-18
• Completion: 2010-11-18
• First posted: 2009-07-02
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

35 sites across 2 countries: United States, Russia