Status:
TERMINATED
Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chemotherapy Induced Anemia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00931606
Start Date
June 1 2009
End Date
November 18 2010
Last Update
September 13 2023
Active Locations (35)
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1
Investigative Site
Sedona, Arizona, United States
2
Investigative Site
Hot Springs, Arkansas, United States
3
Investigative Site
Beverly Hills, California, United States
4
Investigative Site
Corona, California, United States