NCT00708292已完成1 期
An Open-label, Multi-center, Phase I-Ib/II Study of AUY922 Administered as Single Agent and in Combination With Bortezomib With or Without Dexamethasone in Adult Patients in Relapse or Refractory Multiple Myeloma.
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
- 29
- 试验地点
- 3
- 主要终点
- The safe dose of AUY922 when administered once a week.
研究概览
简要总结
This is a Phase I-Ib/II, open-label, multicenter study of AUY922 administered intravenously in patients with multiple myeloma to determine the maximum tolerated dose. The Phase II part will investigate the efficacy of AUY922 in patients with multiple myeloma. Additionally, the study includes a Phase Ib combination part of AUY922 administered in combination with bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Agent AUY922
Experimental
干预措施: AUY922 (Drug)
AUY922 + Bortezomib
Experimental
干预措施: AUY922 (Drug)
AUY922 + Bortezomib
Experimental
干预措施: Bortezomib (Drug)
AUY922 + Bortezomib + Dexamethasone
Experimental
干预措施: AUY922 (Drug)
AUY922 + Bortezomib + Dexamethasone
Experimental
干预措施: Bortezomib (Drug)
AUY922 + Bortezomib + Dexamethasone
Experimental
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The safe dose of AUY922 when administered once a week.
时间窗: 54 weeks (Maximum Tolerated Dose (MTD))
次要结局
- The safe dose of AUY922 when administered once a week in combination with bortezomib and dexamethasone.(24 weeks (MTD determination of dual and triple combination))
- Efficacy of AUY922 administered once a week alone and in combination(at baseline and every 2 cycles (time to document tumor progression))
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
Phase II Trial of AUY922 vs. Comparators in Advanced Gastric CancerAdvanced Gastric CancerGastro-esophageal Junction CancerNCT01084330Novartis Pharmaceuticals68
已完成
2 期
A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy.Non-small-cell Lung CancerNCT01124864Novartis Pharmaceuticals153
终止
2 期
Phase II of AUY922 in Second-line Gastric Cancer in Combination With Trastuzumab in HER2 Positive PatientsAdvanced Gastric CancerNCT01402401Novartis Pharmaceuticals21
已完成
2 期
AUY922 in Patient With Stage IV NSCLCNon-small Cell Lung Cancer (NSCLC)NCT01922583National Taiwan University Hospital31
终止
2 期
An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR MutationsAdvanced Non Small Cell Lung Cancer (NSCLC)NCT01646125Novartis Pharmaceuticals59