A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Subjects With Treatment Emergent Adverse Events
研究概览
简要总结
To determine the maximum tolerated dose (MTD) of OPB-51602
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.
- •Patients who are responsive or have relapsed following standard treatment
- •Patients capable of providing written informed consent
- •Japanese patients age 20 to 75 years (inclusive) at time of informed consent
- •ECOG performance status score of 0-1
- •Life expectancy of at least 3 months
- •Adequate vital organ function
- •Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration
排除标准
- •Patients with other primary malignant tumors
- •Symptomatic CNS involvement
- •Ongoing or active infection, or complication that is not controllable by medication or other means
- •Complication of uncontrolled cardiac disease
- •Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period
- •Patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment
研究组 & 干预措施
OPB-51602
OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
干预措施: OPB-51602 (Drug)
结局指标
主要结局
Subjects With Treatment Emergent Adverse Events
时间窗: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
时间窗: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).
次要结局
- Treatment Response(From first dose of study medication to withdrawal examination)