Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Chemotherapy Induced Anemia

Treatments: Drug: Placebo; Biological: Sotatercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00931606

MK-7962-012 (Other Identifier)

A011-08

7962-012

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 4 patient groups, including a placebo group

Sotatercept 0.1 mg/kg

Experimental group

Description:

Participants will receive sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.

Treatment:

Biological: Sotatercept

Sotatercept 0.3 mg/kg

Experimental group

Description:

Participants will receive sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.

Treatment:

Biological: Sotatercept

Sotatercept 0.5 mg/kg

Experimental group

Description:

Participants will receive sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.

Treatment:

Biological: Sotatercept

Placebo

Placebo Comparator group

Description:

Participants will receive placebo subcutaneously every 28 days up to 4 doses.

Treatment:

Drug: Placebo