A Phase 2, Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Voreloxin (Vosaroxin) Injection in Patients Equal to or Greater Than 60 Years of Age With Previously Untreated Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 19
- 主要终点
- Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions
研究概览
简要总结
This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML
详细描述
Other objectives of this study include:
- Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality
- Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR).
- Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population.
- Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 60 years of age and diagnosis of previously untreated AML (either de novo or from an antecedent hematologic disorder or therapy related AML)
- •At least 20% blasts by BM biopsy or aspirate
- •ECOG performance status of 0,1,or 2
- •Adequate cardiac, renal and liver function
排除标准
- •Uncontrolled DIC
- •Active central nervous system involvement by AML
- •Requiring hemodialysis or peritoneal dialysis
- •Some prior history of heart attack or stroke (depending on how long ago the event occurred)
研究组 & 干预措施
All Study Patients
- Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15
- Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8
- Schedule C: 72 mg/m2 on Days 1 and 4, or
- Schedule C: 90 mg/m2 on Days 1 and 4
干预措施: vosaroxin (Drug)
结局指标
主要结局
Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions
时间窗: 2 years
Combined remission rate (complete remission \[CR\] + complete remission with incomplete platelet recovery \[CRp\]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set. Per IWG criteria, a CR requires bone marrow blasts \< 5%, absolute neutrophil count (ANC) \> 1000 cells/uL, and platelet (plt) count \> 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count \<= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.
次要结局
- Leukemia-free Survival (LFS)(2 years)
- Overall Survival(2 years)
- Pharmacokinetics Day 1 - Cmax (ng/mL)(1 Day)
- Pharmacokinetics Day 4 Cmax (ng/mL)(Day 4)
- All Cause Mortality(30 and 60 days)
- Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)(1 Day)
- Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)(1 Day)
- Pharmacokinetics Day 1 - CL (L/hr)(1 Day)
- Pharmacokinetics Day 1 - Vss (L)(1 Day)
- Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)(Day 4)
- Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)(Day 4)
- Pharmacokinetics Day 4 - CL (L/hr)(Day 4)
- Pharmacokinetics Day 4 - Vss (L)(Day 4)