NCT01940133已完成1 期
Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)
研究概览
简要总结
This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.
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
- •Histologically or cytologically confirmed diagnosis of advanced solid tumor for which no therapy of proven efficacy is available.
- •Evidence of tumor progression with measurable or evaluable disease.
- •Use of adequate contraceptive measures for male patients.
- •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-
- •Signed informed consent.
排除标准
- •Concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors)
- •Patients with a history of myocardial infarction or coronary artery bypass within the last 3 years.
- •Patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure NYHA Class 3 or 4, hypertension BP>150/100mmHg.
- •Pre-diagnosed diabetes mellitus.
- •Fasting glucose > 7.0 mmol/L or HbA1c > 6%.
研究组 & 干预措施
PQR309
Experimental
Different dose evaluation
干预措施: PQR309 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)
时间窗: In average 1 year
次要结局
- To determine overall safety(1 year)
研究者
研究点 (1)
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