NCT00113529已完成1 期
A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma
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
- Pfizer
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).
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
- •Histologically confirmed renal cell carcinoma with metastases
- •Evidence of unidimensionally measurable disease
- •Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC
排除标准
- •RCC without any clear (conventional) cell component
- •History of or known brain metastases
- •Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry
研究组 & 干预措施
Sunitinib + Gefitinib
Experimental
Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib
Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib
干预措施: Gefitinib + Sunitinib (Drug)
结局指标
主要结局
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
次要结局
- Ctrough of SU-012662 (Sunitinib's Metabolite)(prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28))
- Time to Tumor Response (TTR)(From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter)
- Duration of Response (DR)(From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer)
- Time to Tumor Progression (TTP)(From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter)
- Overall Survival (OS)(From start of study treatment until death)
- Progression-Free Survival (PFS)(From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death)
- Probability of Survival at One Year(From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year)
- VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline(Baseline (Cycle 1, Day 1))
- VEGF Ratio to Baseline at Each Time Point(Baseline to Cycle 3, Day 28 inclusive)
- VEGF-C Concentration at Baseline(Baseline (Cycle 1, Day 1))
- VEGF-C Ratio to Baseline at Each Time Point(Baseline to Cycle 3, Day 28 inclusive)
- Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline(Baseline (Cycle 1, Day 1))
- sVEGFR2 Ratio to Baseline at Each Time Point(Baseline to Cycle 3, Day 28 inclusive)
- Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline(Baseline (Cycle 1, Day 1))
- sVEGFR3 Ratio to Baseline at Each Time Point(Baseline to Cycle 3, Day 28 inclusive)
- Ctrough of Gefitinib(prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28))
- Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median(Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive)
- Trough Plasma Concentrations (Ctrough) of Sunitinib(prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28))
研究者
研究点 (1)
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