An Open-label, Multi-centre Phase I Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Determination of maximum tolerated dose (MTD) of PG545
研究概览
简要总结
This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused 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.
- •LIfe expectancy >= 12 weeks.
- •ECOG performance status 0 or
- •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
- •Concomitant use of aspirin (> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose), 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 vies (HIV)
- •Women who are pregnant or breast feeding
- •Women of child-bearing potential and male subjects who are partners of women of child bearing potential who are unable or unwilling to use effective means of contraception.
- •Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.
研究组 & 干预措施
PG545
Once weekly, one hour IV infusion of PG545.
干预措施: PG545 (Drug)
结局指标
主要结局
Determination of maximum tolerated dose (MTD) of PG545
时间窗: Evaluated at the end of initial 28-day cycle
The MTD will be determined by assessing dose limiting toxicities at the end of the first month's treatment. Dose escalation and de-escalation will continue until an MTD is identified. Each cohort of patients will receive weekly doses at a single dose level for the duration of the study.
次要结局
- Number of adverse events by cohort(Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment)
- Assessment of the anti-tumour activity of PG545 using RECIST criteria(Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment)
- Severity of adverse events by cohort(Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment)