NL-OMON41861已完成不适用
A Multicenter, Open-Label, Dose-Escalating Phase I Trial of the DNA-PK Inhibitor MSC2490484A in Subjects With Advanced Solid Tumors or Chronic Lymphocytic Leukemia - DNA-PK Single-Agent Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Merck
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*Advanced solid tumors likely to have alterations in DNA repair mechanisms, such as the BRCA and ATM pathways), or CLL, with no other standard surgical, radiation, or systemic anticancer therapies available;*Tumor accessible for biopsies and agree to pretreatment tumor biopsy;*Measurable or evaluable disease in accordance with RECIST v 1.1 for solid tumors or Cheson*s criteria for CLL;*Male or female subjects at least 18 years of age who sign written informed consent.
排除标准
- •1. Eastern Cooperative Oncology Group performance status > 1;2. Received:
- •a. Chemotherapy, immunotherapy, hormonal therapy with the exception
- •of luteinizing hormone releasing hormone (LHRH) analogs, biologic
- •therapy, or any other anticancer therapy within 28 days prior to the first
- •dose of IMP administration (6 weeks for nitrosoureas or mitomycin C)
- •b. Any investigational agent within 28 days prior to the first dose of IMP
- •administration
- •c. Extensive prior radiotherapy on more than 30% of bone marrow
- •reserves or prior bone marrow/stem cell transplantation within 5 years
- •before study start. The extent of previous radiotherapy to the bone
- •marrow will be determined by the investigator
- •3. Subjects currently receiving (or unable to stop using prior to receiving
- •the first dose of trial drug) medications or herbal supplements known to
- •be potent inhibitors of CYP3A or CYP2C19 (must stop at least 1 week
- •prior), potent inducers of CYP3A or CYP2C19 (must stop at least 3 weeks
- •prior), or drugs mainly metabolized by CYP3A with a narrow therapeutic
- •index (must stop at least one day prior)
研究者
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