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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved a Hematopoietic Response
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
- •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
- •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).
研究组 & 干预措施
Sotatercept 0.1 mg/kg
Participants will receive sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
干预措施: Sotatercept (Biological)
Sotatercept 0.3 mg/kg
Participants will receive sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
干预措施: Sotatercept (Biological)
Sotatercept 0.5 mg/kg
Participants will receive sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
干预措施: Sotatercept (Biological)
Placebo
Participants will receive placebo subcutaneously every 28 days up to 4 doses.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved a Hematopoietic Response
时间窗: Baseline and Up to ~145 Days
Hematopoietic response rate is defined as the percentage of participants who had 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 study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented.
次要结局
- Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL(Baseline and Up to ~145 Days)
- Number of Participants Who Discontinued Study Intervention Due to an Adverse Event(Up to ~85 Days)
- Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL(Baseline and Up to ~145 Days)
- Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline(Baseline and Up to ~145 Days)
- Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1).(Baseline and Day 64)
- Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline(Baseline and Up to ~145 Days)
- Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL(Baseline and Up to ~145 Days)
- Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1.(Day 113)
- Number of Participants Who Experienced an Adverse Event (AE)(Up to ~175 Days)
- Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL(Baseline and Up to ~145 Days)
- Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL(Baseline and Up to ~145 Days)
- Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL(Baseline and Up to ~145 Days)
- Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL(Baseline and Up to ~145 Days)
- Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL(Baseline and Up to ~145 Days)
- Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL(Baseline and Up to ~145 Days)
- Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline(Baseline and Up to ~145 Days)
- Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA(Up to Day 141)
- Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1.(Day 64)
- Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1.(Day 113)
- Progression-free Survival (PFS)(From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281)
- Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL(Baseline and Up to ~145 Days)