A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model
研究概览
简要总结
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.
The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.
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
- 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
- •Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
- •Measurable disease
排除标准
- •Prior systemic therapy of any kind for advanced renal cell cancer
- •History of brain metastases
- •Uncontrolled hypertension
研究组 & 干预措施
C
干预措施: Sunitinib Malate Continuous Daily Dosing (Drug)
A
干预措施: Sunitinib Malate Schedule 4/2 (Drug)
结局指标
主要结局
Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model
时间窗: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=\>3) based on number of criteria present such as Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal,Hemoglobin \< lower limit of normal, serum calcium \> 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.
次要结局
- Duration of Response (DR)(From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years)
- Percentage of Participants With Objective Response (OR)(From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years)
- Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model(From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years)