NCT00137449已完成2 期
A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Advanced Gastrointestinal Stromal Tumor
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
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Benefit Response (CBR) According to RECIST
研究概览
简要总结
To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule
详细描述
Subjects experiencing clinical benefit after 1 year on study were offered continued treatment with SU011248 on a separate protocol.
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
- •Histopathologically proven diagnosis of malignant GIST that was not amenable to standard therapy.
- •Failed prior treatment with imatinib mesylate, defined either by progression of disease (according to Response Evaluation Criterion in Solid Tumors (RECIST) or World Health Organization (WHO) criteria), or by significant toxicity during treatment with imatinib mesylate that precluded further treatment. Intolerance to prior imatinib mesylate therapy was defined as follows:
- •Life-threatening adverse events (ie, Grade 4) at any dose (attempt to dose reduce or rechallenge not required) or Unacceptable toxicity induced by a moderate dose (eg, 400 mg/day), specifically, Grade 2 toxicity that was unacceptable to the patient (such as nausea) that persisted despite standard countermeasures
- •Evidence of unidimensionally measurable disease.
排除标准
- •Previous treatment on a SU011248 clinical trial.
- •Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma, that had 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.
- •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 could not be controlled by medications (>150/100 mm/Hg despite optimal medical therapy).
研究组 & 干预措施
A
Experimental
干预措施: SU011248 (Drug)
结局指标
主要结局
Number of Participants With Clinical Benefit Response (CBR) According to RECIST
时间窗: Planned duration on this protocol of up to 1 year
CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging \>= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders.
次要结局
- Number of Participants by Best Confirmed Response Category According to RECIST(Planned duration on this protocol of up to 1 year)
- Number of Participants With Overall Confirmed Objective Disease Response (ORR)(Planned duration on this protocol of up to 1 year)
- Duration of Stable Disease(Planned duration on this protocol of up to 1 year)
- Progression-free Survival (PFS)(Planned duration on this protocol of up to 1 year)
- Time to Tumor Progression (TTP)(Planned duration on this protocol of up to 1 year)
- Duration of Tumor Response (DR) [Descriptive Statistics](Planned duration on this protocol of up to 1 year)
- Overall Survival (OS) and One-year Survival [Descriptive Statistics](Survival status was collected by telephone contact every 2 months for up to 2 years from study entry.)
- Score of FACIT-Fatigue Scale(Baseline, Day 1 & 15 of each treatment cycle)
- Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale)(Baseline, Day 1 &15 of each treatment cycle up to 1 year on study)
- Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index(Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study)
研究者
研究点 (1)
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