NCT05301517已完成3 期
A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of Roxadustat for Treatment of Anemia in Subjects Receiving Chemotherapy Treatment for Non-Myeloid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 159
- 试验地点
- 45
- 主要终点
- Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13
研究概览
简要总结
The main goal of this study is to evaluate the efficacy of roxadustat for treatment of anemia in participants with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy.
详细描述
Participants who are eligible for participation will be randomized to roxadustat and SEPO® (recombinant human erythropoietin-α [rHuEPO-α]), and undergo a 12-week treatment period followed by a 4-week follow-up period.
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
- 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, by histological or cytological confirmation.
- •Anemia related to myelosuppressive chemotherapy, defined as Hb ≤100 g/L at screening with documented participant's Hb level decrease ≥10 g/L after the initiation of chemotherapy as judged by the investigator.
- •Planned concurrent treatment of cancer (myelosuppressive chemotherapy) for at least 8 additional weeks.
- •Body weight ≥40 kg.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 1 or
- •Ferritin ≥50 nanograms (ng)/milliliter (mL) and transferrin saturation (TSAT) ≥10%.
排除标准
- •Participants with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
- •Participants who are only receiving hormonal products, biological products, novel immunosuppressive products (such as programmed cell death protein-1 [PD-1] and programmed death-ligand 1 [PD-L1] checkpoint inhibitors) or targeted biological or radiation therapy to treat/manage their cancer, however if chemotherapy is co-administered with these products, then it is acceptable to enroll the participant.
- •Participants with hematocrit (HCT) ≥36%.
- •Participants who have received an RBC transfusion or ESA within 4 weeks of randomization.
- •Thromboembolic event (including but not limited to deep vein thrombosis [DVT], pulmonary embolism, myocardial infarction, stroke, transient ischemic attack [TIA] within previous 6 months of screening.
- •Clinically significant anemia due to other etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, or hereditary anemia such as sickle cell anemia or thalassemia.
- •The Investigator judges that the participant will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, addiction, or any other relevant medical conditions.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Roxadustat
Experimental
Participants will receive roxadustat, administered orally 3 times per week (TIW) for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be based on the participant's weight group. The maximum dose for individual participants may not exceed 3.5 milligrams (mg)/kilogram (kg) or 400 mg TIW whichever is lower.
干预措施: Roxadustat (Drug)
SEPO®
Active Comparator
Participants will receive SEPO®, injected subcutaneously TIW for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be 150 international units (IU)/kg subcutaneously TIW.
干预措施: SEPO® (Drug)
结局指标
主要结局
Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13
时间窗: Baseline, Weeks 9 through 13
Hb levels measured from Weeks 9 through 13 will be averaged in order to provide a single measure for comparison to the baseline Hb levels.
次要结局
- Percentage of Participants who Achieve a ≥10 Grams (g)/Liter (L) Increase in Hb From Baseline Through Week 13(Baseline through Week 13)
- Percentage of Participants who Require Red Blood Cell (RBC) Transfusion or Hb <60 g/L or with any Hb< 60 g/L From Week 5 Through Week 13(Week 5 through Week 13)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Subscale Score Averaged Over Weeks 9-13(Baseline, Weeks 9 through 13)
- Percentage of Participants who Require Dose Reduction or a Dose-Hold of Chemotherapy Due to Anemia(Baseline through Week 13)
- Percentage of Participants who Achieve a ≥ 15 g/L Increase in Hb From Baseline Through Week 13(Baseline through Week 13)
- Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale Score Averaged Over Weeks 9-13(Baseline, Weeks 9 through 13)
- Change in Hb From Baseline up to 4 Weeks After the Last Dose of Chemotherapy During the Treatment Period(Baseline up to 4 weeks after the last dose of chemotherapy (up to Week 16))
- Change in Hb From Baseline Through Week 9(Baseline through Week 9)
- Change in Hb From Baseline Through Week 13(Baseline through Week 13)
- Percentage of Participants Requiring 1 or More RBC Transfusion(Baseline up to Week 13)
- Percentage of Participants who Achieve Hb Levels ≥ 110 g/L From Baseline Through Week 13(Baseline through Week 13)
- Percentage of Participants who Achieve an Increase in Hb of 15 g/L or Attaining a Hb of 110 g/L From Baseline Through Week 13(Baseline through Week 13)
- Time to First RBC Transfusion(Baseline up to Week 13)
- Number of RBC Transfusions Adjusted for Exposure From Baseline Through Week 13(Baseline through Week 13)
- Percentage of Participants who Require RBC Transfusion as Medical Intervention and/or Erythropoiesis-Stimulating Agent (ESA) as a Rescue Agent(Baseline through Week 13)
研究者
研究点 (45)
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