NCT00089960已完成2 期
An Open Label Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 138
- 主要终点
- Objective response rate as defined using modified RECIST criteria.
研究概览
简要总结
This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.
详细描述
Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm
Other
AMG 125 mg daily continuously
干预措施: AMG 706 (Drug)
结局指标
主要结局
Objective response rate as defined using modified RECIST criteria.
时间窗: 48 weeks treatment or until progressive disease, or unacceptable toxicity
次要结局
- Progression-free survival(time from randomization to progressive disease)
- Overall survival(time to death)
- Time to progression(time from response to progressive disease)
- Time to response(time from first treatment to response)
- Patient-reported outcomes(quality of life)
- Use of opioid analgesics after minimal 6 months treatment(narcotics usage during study)
- Objective response by PET and tumor size/density changes at week 8(response rate at week 8)
- Objective response by size changes and/or target tumor density changes at week 8(response rate at week 8)
- Safety Endpoints: Incidence of adverse events (including all, serious, grade 3, grade 4 and treatment related)(for duration of study)
- Duration of response(time to respone to progression)
- Palliative response(amelioration of symptoms)
- Pharmacokinetic Endpoints: 1. The AMG 706 PK parameters (Cmax, t1/2, AUC0-24, C24); 2. To explore the PK/PD relationships(during specific study timepoints)
研究者
相似试验
已完成
2 期
Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal TumorsAdvanced Gastrointestinal Stromal TumorNCT00254267Amgen35
终止
1 期
Single Ascending Dose Trial in Patients With Type 2 DiabetesDiabetes MellitusNCT01492465Amgen47
已完成
1 期
Effect of Different Doses of AMG 706 on the Gallbladder in Advanced Solid TumorsSolid TumorsNCT00448786Amgen49
已完成
1 期
Study Evaluating AMG 706 in Subjects With Advanced Solid TumorsTumorsNCT00093873Amgen71
已完成
2 期
A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid CancerThyroid CancerNCT00121628Amgen184