NCT00626704已完成1 期
A Phase 1b/2 Study of AMG 655 in Combination With Doxorubicin for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 134
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Histologically or cytologically confirmed soft tissue sarcoma
- •Locally advanced, recurrent, or metastatic, unresectable disease
- •Measurable disease according to modified RECIST
- •ECOG performance status of 0 or 1
- •Men or women at least 18 years of age
- •Adequate hematological, renal, hepatic, and coagulation function
排除标准
- •Prior treatment with anthracyclines
- •Uncontrolled cardiovascular disease
研究组 & 干预措施
Arm 1
Experimental
AMG 655 + Doxorubicin
干预措施: AMG 655 (Drug)
Arm 1
Experimental
AMG 655 + Doxorubicin
干预措施: Doxorubicin (Drug)
Arm 2
Placebo Comparator
Placebo + Doxorubicin
干预措施: Placebo (Other)
Arm 2
Placebo Comparator
Placebo + Doxorubicin
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: Length of Study
次要结局
- Objective response rate, time to response, duration of response, clinical benefit rate, overall survival, incidence of adverse events and clinical laboratory abnormalities, and incidence of anti-AMG 655 antibody formation.(Length of Study)
研究者
相似试验
已完成
1 期
Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal CancerMetastatic Colorectal CancerRectal CancerColorectal CancerColon CancerNCT00625651Amgen202
已完成
1 期
Conatumumab/Panitumumab Combination Metastatic Colorectal Cancer StudyRectal CancerMetastatic Colorectal CancerOncologyColorectal CancerColon CancerNCT00630786Amgen53
已完成
1 期
A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT00534027Amgen172
已完成
1 期
QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic CancerAdenocarcinoma of the PancreasMetastatic Pancreatic CancerPancreatic CancerNCT00630552NantCell, Inc.138
终止
1 期
QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid TumorsLocally AdvancedMetastatic CancerColorectal CancerPancreatic CancerSolid TumorsSarcomaOvarian CancerNon-Small Cell Lung CancerNCT00819169NantCell, Inc.89