NCT01226901终止1 期
A Phase I Study of MK-4827 in Patients With Solid Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 主要终点
- Incidence of dose-limiting toxicities (DLTs) in Cycle 1
研究概览
简要总结
This study will evaluate whether oral administration of MK-4827 to participants with advanced solid tumors is generally safe and well tolerated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must have a histologically or cytologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. There is no limit on the number of prior treatment regimens.
- •Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale
- •Participant must have adequate organ function (per prespecified laboratory values).
排除标准
- •Participant has had major surgery, chemotherapy, radiotherapy, hormonal or biological therapy within 4 weeks (6 weeks for nitrosoureas, mitomycin C, or bevacizumab) prior to entering the study.
- •Participant has known central nervous system metastases or a primary central nervous system tumor.
- •Participant is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study.
- •Participant is known to be Human Immunodeficiency Virus (HIV)-positive.
- •Participant with active Hepatitis B or C.
- •Participant has symptomatic ascites or pleural effusion.
- •Participant has interstitial lung disease as a history or current evidence.
- •Participant has known bleeding tendency or coagulation disorder as a history or current evidence, and/or participant is taking any anti-coagulant and/or antiplatelet therapies.
- •Participant has uncontrolled persistent or active infection (acute infection which requires antibiotic or anti-fungal treatment).
- •Participant has participated in a clinical trial with a known Poly (ADP-ribose) polymerase (PARP) inhibitor.
研究组 & 干预措施
MK-4827 once daily
Experimental
MK-4827
干预措施: MK-4827 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs) in Cycle 1
时间窗: Cycle 1 of treatment (1 cycle = 21 days)
Dose-limiting toxicities are defined as all adverse experiences that are clearly not related to disease progression or intercurrent illness. In order to be declared a dose-limiting toxicity, an adverse experience must be related (definitely, probably, or possibly) to study therapy.
次要结局
未报告次要终点
研究者
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