NCT01146171撤回1 期
A Phase I Multiple Ascending Dose Study of BMS-844203 (CT-322) Monotherapy in Japanese Patients With Solid Tumors
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Determine recommended dose for Phase 2 study of CT-322
研究概览
简要总结
The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- •Life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group performance 0-1
排除标准
- •Subject has uncontrolled diabetes or hypertension
- •Clinical significant bleeding diathesis or coagulopathy
- •Thrombotic or embolic cerebrovascular accident
研究组 & 干预措施
BMS-844203 (CT-322)
Experimental
干预措施: BMS-844203 (CT-322) (Drug)
结局指标
主要结局
Determine recommended dose for Phase 2 study of CT-322
时间窗: Within the first 28 days
次要结局
- To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc.(Cycle 2 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter)
- To assess anti-tumor activity of CT-322(Every 8 weeks)
- To assess the effects of CT-322 on plasma VEGF levels(Cycle 3: Day 1)
- To assess the presence of anti CT-322 antibodies(Cycle 3 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of BMS-833923 With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung CancerSmall Cell Lung CarcinomaNCT00927875Bristol-Myers Squibb5
招募中
1 期
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid TumorsGastric/Gastroesophageal Junction AdenocarcinomaMicrosatellite Stable Colorectal CancerNon-Small-Cell Lung CancerSquamous Cell Carcinoma of Head and NeckCarcinoma, Renal CellMelanomaPancreatic AdenocarcinomaOvarian NeoplasmsTriple Negative Breast NeoplasmsCervical CancerUrothelial CarcinomaNCT04895709Bristol-Myers Squibb1,109
已完成
1 期
Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid TumorsCancerNCT01413906Bristol-Myers Squibb12
撤回
1 期
Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced CancersAdvanced Solid TumorsNCT00792558Bristol-Myers Squibb
终止
1 期
A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid TumorsAdvanced Solid CancersMetastatic CancerNCT00886782Bristol-Myers Squibb11