NCT01281592已完成1 期
Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
研究概览
简要总结
This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
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
- •Male or female 18 years of age or older.
- •Histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy.
- •Meet laboratory parameter requirements at study entry.
排除标准
- •Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with LOR-253 HCl.
- •A hematologic malignancy.
- •A history of brain or other central nervous system metastases.
- •Have a presence of a significant infection.
- •Clinically significant autoimmune disease.
- •Uncontrolled intercurrent illness.
- •With iron or copper overload syndromes.
- •Pregnancy or breast feeding.
研究组 & 干预措施
LOR-253 HCl
Experimental
LOR-253 HCl will be given in ascending doses until the maximum administered dose or appropriate target dose is reached. A biomarker study of up to 10 patients will be conducted upon achieving appropriate dose level.
干预措施: LOR-253 HCl (Drug)
结局指标
主要结局
To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
时间窗: 8 weeks
次要结局
- To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours.(8 weeks)
研究者
研究点 (2)
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