NCT01252095终止1 期
An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
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
- 4
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) Based on DLT
研究概览
简要总结
This first-in-human study aims to establish the maximum tolerated dose of PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.
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
- •Age >=18 years.
- •Histological or cytological documentation of non hematologic, malignant solid tumour.
- •Have failed at least one previous therapeutic regimen.
- •Measurable disease according to RECIST 1.
- •Life expectancy >= 12 weeks
- •ECOG Performance Status of 0 or 1
- •Written, signed and dated informed consent
- •Able and willing to meet all protocol-required treatments, investigations and visits.
- •Have adequate organ function
排除标准
- •Clinically significant non-malignant disease.
- •Active CNS metastases.
- •Subjects with uncontrolled diabetes.
- •History of clinically significant adverse drug reaction to heparin or other anti-coagulant agents
- •History of immune-mediated thrombocytopaenia or other platelet abnormalities or other hereditary or acquired coagulopathies.
- •Concomitant use of aspirin (> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose prophylactic use), heparin within two weeks prior to randomisation, or other anti-platelet drugs.
- •History of severe allergic, anaphylactic or other significant adverse reaction to radiographic contrast media
- •Known seropositivity to the human immunodeficiency virus (HIV)
- •Women who are pregnant or breast-feeding.
- •Women of child-bearing potential and male subjects who are partners of women of childbearing potential who are unable or unwilling to practice a highly effective means of contraception.
- •Active substance abuse
- •Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.
研究组 & 干预措施
PG545
Experimental
干预措施: PG545 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) Based on DLT
时间窗: Following first 1 month cycle
The primary objective of this study is the determination of the MTD. Due to the premature termination of the study the MTD could not be determined. The outcome measure presented is the number of DLTs per cohort.
次要结局
未报告次要终点
研究者
研究点 (1)
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