NCT03884829Unknown1 期
A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients With Advanced Leukemias or Myelodysplastic Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Patients who experience dose -limiting toxicity (DLT)
研究概览
简要总结
A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes
详细描述
This is a First in Human, open-label, single arm, dose escalation study in patients with advanced leukemias or myelodysplastic syndromes. Patients will receive CYC140 as a 1 hr infusion once a week for 2 weeks followed by 1 week of rest on an outpatient basis. One treatment cycle is 3 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 relapsed or refractory advanced leukemias or MDS
- •Adequate renal function
- •Adequate liver function
- •≥ 2 weeks from prior chemotherapy, radiation therapy or major surgery
- •≥ 4 weeks from other investigational anticancer therapy
- •Agree to practice effective contraception
排除标准
- •Known CNS involvement by leukemia
- •Currently receiving radiotherapy, biological therapy, or any other investigational agents
- •Uncontrolled intercurrent illness
- •Pregnant or lactating
- •Known to be HIV-positive
- •Known active hepatitis B and/ or hepatitis C infection
研究组 & 干预措施
CYC140 single agent
Experimental
CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle
干预措施: CYC140 (Drug)
结局指标
主要结局
Number of Patients who experience dose -limiting toxicity (DLT)
时间窗: At end of cycle 1 (each cycle is 21 days)
次要结局
- Pharmacokinetic measurement - area under the curve (AUC)(At the end of cycle 1 (each cycle is 21 days))
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
A Phase I Pharmacologic Study of CYC116, an Oral Aurora Kinase Inhibitor, in Patients With Advanced Solid TumorsSolid TumorsNCT00560716Cyclacel Pharmaceuticals, Inc.25
已完成
2 期
A Study of LY2606368 (Prexasertib) in Patients With Solid Tumors With Replicative Stress or Homologous Repair DeficiencyAdvanced CancersNCT02873975Dana-Farber Cancer Institute27
未知
1 期
A Clinical Study Testing The Safety and Efficacy of CH5424802/RO5424802 in Patients with ALK Positive Non-Small Cell Lung CancerALK-Rearranged Non-Small Cell Lung CancerJPRN-jRCT2080221778F. Hoffmann-La Roche, Ltd.121
终止
1 期
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic SyndromeHigh-risk Myelodysplastic SyndromeAcute Myeloid LeukemiaNCT04021368Ryvu Therapeutics SA51
已完成
2 期
A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma,Ewing-Like Sarcoma, and Desmoplastic Small Round Cell TumorEwing-Like SarcomaEwing SarcomaNCT05275426Memorial Sloan Kettering Cancer Center14