NCT00372775已完成2 期
A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases
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
- Pfizer
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.
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
- •Patients with radiologically proven brain metastases secondary to non-small cell lung cancer
- •Received previous whole brain radiation therapy and none, 1 or 2 prior systemic therapy for the treatment of advanced/metastatic non-small cell lung cancer
排除标准
- •Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or leptomeningeal disease.
- •Brain metastases >4 cm in any linear direction
- •Intracranial or intratumoral hemorrhage
研究组 & 干预措施
Sunitinib
Experimental
干预措施: Sunitinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]).
次要结局
- Time to Tumor Progression (TTP)(Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year))
- Time to Neurological Progression (TNP)(Baseline, Day 28 to focal neurological deficit (up to 1 year))
- Number of Participants With Objective Disease Response(Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49)
- Time to Objective Intracranial Progression(Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year))
- Number of Participants With Intracranial Objective Disease Response(Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49)
- Duration of Response (DR)(Day 7 of Week 4 and every 4 weeks up to 1 year)
- Overall Survival (OS)(Baseline until death (up to 1 year))
- Percentage of Participants Surviving at 1 Year(Year 1)
- Number of Deaths Due to Intracranial Versus Systemic Progression(Baseline until death (up to 1 year))
- Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score(Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year))
- Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score(Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year))
- Trough Plasma Concentrations (Ctrough) of Sunitinib(Day 1 of Week 5, 9, and 13)
- Ctrough of Sunitinib Metabolite (SU012662)(Day 1 of Week 5, 9, and 13)
- Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts(Day 1 prior to dosing)
- Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile(Day 1 of Week 1 and every 4 weeks up to 1 year)
- PFS in Subgroups Defined by RNA Expression Profiles of Tumors(Day 1 of Week 1 and every 4 weeks up to 1 year)
研究者
研究点 (1)
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