NCT00083889已完成3 期
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS), Investigator's Assessment
研究概览
简要总结
The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).
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
- •Histologically confirmed renal cell carcinoma of clear cell histology with metastases
- •Evidence of measurable disease by radiographic technique
- •Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1
排除标准
- •Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
- •History of or known brain metastases
- •Serious acute or chronic illness or recent history of significant cardiac abnormality
研究组 & 干预措施
2
Active Comparator
干预措施: Interferon-alfa (Drug)
1
Experimental
干预措施: SU011248 (Drug)
结局指标
主要结局
Progression-Free Survival (PFS), Investigator's Assessment
时间窗: Day 28 of each 6-week cycle: duration of treatment phase
Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.
Progression-Free Survival (PFS), Core Radiology Assessment
时间窗: Day 28 of each 6-week cycle: duration of treatment phase
Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.
次要结局
- Time to Tumor Progression (TTP), Investigator's Assessment(Randomization to first documentation of tumor progression: duration of treatment phase)
- FACT-Kidney Symptom Index (FKSI) Subscale(Day 1 & 28 of each cycle: duration of treatment phase)
- Euro-QoL Visual Analog Scale (EQ-VAS)(Day 1 & 28 of each cycle: duration of treatment phase)
- Overall Survival (OS)(Clinic visit or telephone contact every 2 months until death)
- Time to Tumor Progression (TTP), Core Radiology Assessment(Randomization to first documentation of tumor progression: duration of treatment phase)
- Duration of Response (DR), Core Radiology Assessement(Day 28 of each cycle: duraton of treatment phase)
- Objective Response, Core Radiology Assessment(Day 28 of each 6-week cycle: duration of treatment phase)
- Duration of Response (DR), Investigator's Assessment(Day 28 of each cycle: duration of treatment phase)
- Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale(Day 1 & 28 of each cycle: duration of treatment phase)
- Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale(Day 1 & 28 of each cycle: duration of treatment phase)
- Ctrough Concentrations of Metabolite SU012662(Day 28 of Cycle 1 to Cycle 4)
- Objective Response, Investigator's Assessment(Day 28 of each 6-week cycle: duration of treatment phase)
- FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale(Day 1 & 28 of each cycle: duration of treatment phase)
- Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis(Day 1 & Day 28, Cycle 1 to Cycle 4)
- Ctrough Concentrations of SU011248(Day 28 of Cycle 1 to Cycle 4)
- Functional Assessment of Cancer Therapy-General (FACT-G)(Day 1 & 28 of each cycle: duration of treatment phase)
- Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale(Day 1 & 28 of each cycle: duration of treatment phase)
- EuroQoL Five Dimension (EQ-5D) Health State Index(Day 1 & 28 of each cycle: duration of treatment phase)
- Incremental Cost Effectiveness Ratio (ICER)(post study measurement)
- Ctrough Concentrations of SU011248 and Active Metabolite SU012662(Day 28 of Cycle 1 to Cycle 4)
- Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale(Day 1 & 28 of each cycle: duration of treatment phase)
- Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis(Day 1 & Day 28, Cycle 1 to Cycle 4)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
A Phase 3, Randomized Study of SU011248 versus Interferon-a as First-Line Systemic Therapy for Patients with Metastatic Renal Cell Carcinoma.EUCTR2004-001149-14-ITPFIZER
进行中（未招募）
1 期
A Phase 3, Randomized Study of SU011248 versus Interferon-a as First-Line Systemic Therapy for Patients with Metastatic Renal Cell CarcinomaMedDRA version: 9.1 Level: HLT Classification code 10038408 Term: Renal cell carcinomasRenal Cell CarcinomaEUCTR2004-001149-14-GBPfizer Inc. - 235 East 42nd Street - New York - 10017690
进行中（未招募）
1 期
A Phase 3, Randomized Study of SU011248 versus Interferon-a as First-Line Systemic Therapy for Patients with Metastatic Renal Cell CarcinomaHistologically confirmed renal cell carcinoma with metastases with a component of clear (conventional) cell histology.EUCTR2004-001149-14-ESPfizer, S.A.690
已完成
2 期
SU011248 for Platinum-Refractory Urothelial Cancer Evaluation TrialUrothelial CancerAdultBladder CancerNCT00578526AHS Cancer Control Alberta64
已完成
2 期
Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain MetastasesNon-Small Cell Lung CancerNCT00372775Pfizer66