A Phase 2 Open Label Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients Receiving Chemotherapy Treatment for Non-Myeloid Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion
研究概览
简要总结
The purpose of this study is to find out if roxadustat (also known as FG-4592) is safe and effective for the treatment of anemia in participants receiving chemotherapy treatment for cancer.
详细描述
This study consists of three periods:
- Screening Period up to 28 days
- Treatment Period of up to16 weeks
- A Follow-up period of 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-myeloid malignancy
- •Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0 grams (g)/deciliter (dL) at screening
- •Planned concurrent treatment of cancer with chemotherapy for at least 8 additional weeks
- •Estimated life expectancy ≥ 6 months at enrollment (Day 1)
排除标准
- •Participants with cancer receiving chemotherapy when the anticipated outcome is cure
- •Participants who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy to treat/manage their cancer
- •History of leukemia
- •Participants who have received an RBC transfusion or erythropoietic therapy within 4 weeks of enrollment
- •Use of any investigational drug within 8-weeks prior to treatment with roxadustat
- •Clinically significant anemia due to other etiologies
- •Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (for example, deep vein thrombosis [DVT] or pulmonary embolism) within previous 6 months of screening
- •Clinically significant or uncontrolled ongoing autoimmune disease (for example, rheumatoid arthritis, Crohn's disease, celiac disease, etc.)
- •Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
研究组 & 干预措施
Roxadustat
Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 16 weeks.
干预措施: Roxadustat (Drug)
结局指标
主要结局
Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion
时间窗: Baseline, up to Week 16
Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. All central lab assessments from Day 1 to end of treatment (EOT) or early termination (ET) were included in the evaluation of this endpoint. Hb values within 4 weeks after an RBC transfusion were excluded.
次要结局
- Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion)(Baseline, Week 16)
- Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16(Baseline through Week 16)
- Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16(Baseline through Week 16)
- Percentage of Participants Who Achieved a Hematopoietic Response(Baseline through Week 16)
- Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16(Baseline through Week 16)
- Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)(Baseline, Weeks 9, 13, and 16)
- Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16(Baseline through Week 16)
- Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16(Week 5 to Week 16)