NCT03035591已完成1 期
Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion
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
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy
- •Life expectancy >12 weeks
- •Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression
- •ECOG performance status of 0 to 1
排除标准
- •History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment
- •Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment)
- •History of or current leptomeningeal or brain metastasis or spinal cord compression.
研究组 & 干预措施
ODM-207
Experimental
Escalating doses of ODM-207
干预措施: ODM-207 (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 28 days
Highest dose level at which \<33% of patients in a cohort experience Dose Limiting Toxicity (DLT)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
First in human study with ODM-207 in patients with selected advanced cancers to assess its safety and how the body affects itAdvanced Solid TumoursMedDRA version: 20.0Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864EUCTR2015-004826-32-GBOrion Corporation Orion Pharma144
进行中（未招募）
1 期
First in human study with ODM-207 in patients with selected advanced cancers to assess its safety and how the body affects itAdvanced Solid TumoursMedDRA version: 19.0 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 100000004864EUCTR2015-004826-32-ESOrion Corporation Orion Pharma144
进行中（未招募）
1 期
First in human study with ODM-207 in patients with selected advanced cancers to assess its safety and how the body affects itAdvanced Solid TumoursMedDRA version: 20.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 100000004864EUCTR2015-004826-32-FIOrion Corporation Orion Pharma144
进行中（未招募）
1 期
First in human study with ODM-207 in patients with selected advanced cancers to assess its safety and how the body affects itAdvanced Solid TumoursMedDRA version: 19.0Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864EUCTR2015-004826-32-FROrion Corporation Orion Pharma144
已完成
1 期
Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate CancerProstate CancerNCT02344017Orion Corporation, Orion Pharma23