NCT00137423已完成2 期
A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
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
- 107
- 试验地点
- 1
- 主要终点
- Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects
研究概览
简要总结
To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen
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 proven renal cell carcinoma with metastases.
- •Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
- •Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated with IFN-á alone must have received IFN-á for at least 4 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Resolution of all acute toxic effects of prior therapy or surgical procedures to grade
- •Adequate organ function
排除标准
- •Prior treatment with any systemic therapy other than 1 cytokine-based therapy.
- •Previous treatment on a SU011248 (sunitinib) clinical trial.
- •Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
- •Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
- •History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
- •Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- •Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.
- •Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
- •Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- •Known human immunodeficiency virus (HIV) infection.
研究组 & 干预措施
SU011248 (sunitinib)
Experimental
Single-arm study
干预措施: SU011248 (sunitinib) (Drug)
结局指标
主要结局
Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects
时间窗: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were \> 4 weeks apart. CR=disappearance of all target lesions. PR is 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
- Duration of Tumor Response(4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up)
- Time to Tumor Progression (TTP)(4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up)
- Progression Free Survival (PFS)(4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up)
- Overall Survival(4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up)
- Summary of FACIT Fatigue Scale Overall Score(Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.)
- Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index(Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.)
- Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score(Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.)
研究者
研究点 (1)
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