NCT00467025已完成2 期
A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination With AMG 386 or Placebo In Subjects With Metastatic Clear Cell Carcinoma of the Kidney
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
- 152
- 主要终点
- Progression Free Survival
研究概览
简要总结
This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects must have a histologically confirmed metastatic RCC with a clear cell component
- •Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification.
- •Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications
- •Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening.
- •ECOG of 0 or 1
排除标准
- •Disease Related
- •Known history of central nervous system metastases.
- •Previous treatment (excluding surgery and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
- •Focal radiation therapy for palliation of pain from bony metastases within 14 days of randomization.
- •Medications
- •Currently or previously treated with inhibitors of VEGF.
- •Currently or previously treated with inhibitors of angiopoietin or Tie
- •Currently or previously treated with bevacizumab.
- •General Medical
- •Diagnosis of acute pancreatitis.
- •Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, grade 2 or greater peripheral vascular disease, arrhythmias not controlled by outpatient medication, or unstable angina within 1 year prior to randomization
- •Major surgery within 30 days before randomization or still recovering from prior surgery
- •Uncontrolled hypertension as defined as diastolic > 90 mmHg OR systolic >150 mmHg. Anti-hypertensive medications are permitted.
- •Other investigational procedures are excluded
- •Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
研究组 & 干预措施
Arm A
Experimental
干预措施: AMG 386 (Drug)
Arm A
Experimental
干预措施: Sorafenib (Drug)
Arm A
Experimental
干预措施: AMG 386 placebo IV (Drug)
Arm B
Experimental
干预措施: AMG 386 (Drug)
Arm B
Experimental
干预措施: Sorafenib (Drug)
Arm C
Active Comparator
干预措施: Sorafenib (Drug)
Arm C
Active Comparator
干预措施: AMG 386 placebo IV (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 2 3/4 years
次要结局
- Objective response rate (ORR)(2 3/4 years)
- Duration of response (DOR)(2 3/4 years)
- Change in continuous measures of tumor burden(2 3/4 years)
- Time-adjusted area under the curve (AUC) for the FACT-Kidney Cancer Symptom Index (FKSI-15) scale score from baseline through disease progression with imputation for missing data(2 3/4 years)
- Incidence of AEs and significant laboratory changes(2 3/4 years)
- Incidence of the occurrence of anti-AMG 386 antibody formation(2 3/4 years)
研究者
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