A Single-arm, Open-label, Multi-center, Phase Iv, Efficacy And Safety Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Gastrointestinal Stromal Tumor After Disease Progression On Or Intolerance To Imatinib Mesylate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 diagnosis of malignant GIST (Gastrointestinal Stromal Tumors).
- •Evidence of unidimensionally measurable disease
- •Failure of prior treatment with imatinib or intolerant to imatinib
- •Male or female, 18 years of age or older.
- •ECOG (Eastern Cooperative Oncology Group) performance status 0 or
- •Resolution of all acute toxic effects
- •Adequate organ function.
排除标准
- •Anticancer treatment after last dose of imatinib
- •Major surgery within 4 weeks or radiation therapy within 2 weeks.
- •Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.
- •Diagnosis of second malignancy within the last 5 years.
- •History of brain disease.
- •Cardiac disease within 12 months.
- •Thyroid function abnormality.
- •Ongoing cardiac dysrhythmias.
- •Uncontrolled hypertension.
- •Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.
- •HIV or AIDS related illness.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
sunitinib
single agent sunitinib, single arm
干预措施: Sunitinib Malate (SU011248) (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks)
PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven't yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a \>=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.
次要结局
- Overall Survival (OS)(Baseline (Day 1) to death (up to 282 weeks))
- Objective Response Rate (ORR)(Baseline (Day 1) up to end of study treatment (up to 276 weeks))
- Time to Tumor Progression (TTP)(Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks))
- Number of Participants With Abnormal Clinical Laboratory Measurements(Baseline up to 28 days post last administration of study drug)
- Number of Participants With Significant Changes From Baseline in Physical Examination.(Baseline up to 28 days post last administration of study drug)
- Number of Participants With Significant Vital Signs Changes From Baseline(Baseline (Day 1) up to 28 days post last administration of study drug)
- Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug))