NCT00880308已完成1 期
A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
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
- 103
- 试验地点
- 3
- 主要终点
- determine maximum tolerated dose of single agent LDE225
研究概览
简要总结
This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule 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
- •confirmed diagnosis of advanced solid tumor (including •medulloblastoma and basal cell carcinoma)
- •blood work criteria
排除标准
- •patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases
- •positive HIV, hepatitis B or C
- •impaired intestinal function
- •impaired heart function
- •pregnant or breast-feeding women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LDE225
Experimental
干预措施: LDE225 (Drug)
结局指标
主要结局
determine maximum tolerated dose of single agent LDE225
时间窗: 28 day cycles
次要结局
- assess preliminary anti-tumor activity(every other 28-day cycle)
- characterize safety and tolerability(28 day cycles)
- characterize pharmacokinetics (PK) of single and repeated doses of LDE225(28 day cycles)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid TumorsAdvanced Solid TumorsRecurrent or Refractory MedulloblastomaLocally Advanced or Metastatic Basal Cell CarcinomaNCT01106508Novartis Pharmaceuticals57
已完成
1 期
A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants With Locally Advanced or Metastatic Solid TumorsNeoplasmsNCT02219724Genentech, Inc.174
进行中（未招募）
1 期
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid TumorsLocally Advanced Solid TumorsRecurrent Solid TumorsMetastatic Solid TumorsNCT06031441Genentech, Inc.65
已完成
1 期
Pharmacokinetic and Safety Study of MRX-2843 in Adults With Relapsed/Refractory Advanced and/or Metastatic Solid TumorsAdvanced CancerMetastatic CancerNeoplasmsNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesNCT03510104Meryx, Inc.42
尚未招募
1 期
A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 AlterationsSolid Tumors With FGFR2 Alterations, AdultNCT062879183H (Suzhou) Pharmaceuticals Co., Ltd.130