NCT02606097已完成2 期
A Phase 2 Study of Regorafenib in Metastatic Gastrointestinal Stromal Tumours With C-KIT exon17 Mutation
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2014年4月最近更新:
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
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Overall clinical benefit rate
研究概览
简要总结
The main purpose of this study is to examine whether regorafenib treatment can help people with gastrointestinal stromal tumours (GIST) and have gene mutation on c-kit exon 17. The safety of regorafenib treatment is also examined.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An eligible subject must fulfill all of the following inclusion criteria:
- •Signed informed consent (IC) obtained before any study specific procedure. Patients must be able to understand and willing to sign the written IC.
- •Pathologically confirmed gastrointestinal stromal tumours.
- •All patients had received imatinib or sunitinib.
- •Pathological confirmed c-kit exon 17 mutation.
- •At least one measurable lesion in a non-irradiated area or allowed to be tracked whether there are circumstances recurrence by computed tomography (CT) or magnetic resonance imaging (MRI).
- •Aged > 20 years old.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Life expectancy greater than 12 weeks.
- •Adequate bone marrow function: 1) Absolutely neutrophil count >= 1.5 x10^9/L or white blood cell count (WBC) >= 4x10^9/L; 2) Hemoglobin >= 9 g/dL; 3) Platelet count >= 100x10^9/L.
- •Adequate liver function: 1) Total bilirubin <= 1.5x the upper limit of normal (ULN); 2) Alanine Aminotransferase (ALT) & Aspartate Aminotransferase (AST) <= 2.5x ULN if without liver metastasis or <= 5x ULN if with hepatic metastasis; 3) Alkaline phosphatase <= 2.5x ULN if without liver metastasis or <= 5x ULN if with hepatic metastasis or bone metastasis; 4) Bilirubin < 2x ULN.
- •Adequate renal function: creatinine <1.5x ULN.
- •Patients must be accessible for treatment and follow-up in the participating centers.
排除标准
- •Subject will not meet any of the following exclusion criteria:
- •Major surgery within four weeks prior to entering the study.
- •Patients with central nervous system (CNS) metastasis, including clinical suspicion.
- •Patients who are under active or uncontrolled infections.
- •Patients who with unstable angina (angina symptoms at rest, new-onset angina (begun within the last 3 months) or myocardial infarction history 6 months before entry.
- •Cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- •Congestive heart failure New York Heart Association (NYHA) class
- •Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management.
- •Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication.
- •Patients who are pregnant or with breast feeding.
- •Other concomitant or previously malignancy within 5 years except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
- •Mental status is not fit for clinical trial.
- •Cannot take study medication orally.
- •Fertile men and women unless using a reliable and appropriate contraceptive method.
- •Patients with evidence or history of any bleeding diathesis, irrespective of severity.
- •Any hemorrhage or bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks prior to the start of study medication.
- •Non-healing wound, ulcer, or bone fracture.
- •Renal failure requiring hemo-or peritoneal dialysis.
研究组 & 干预措施
regorafenib
Experimental
regorafenib 160 mg daily, 3 weeks on/1 week off
干预措施: regorafenib (Drug)
结局指标
主要结局
Overall clinical benefit rate
时间窗: till 2 weeks after last dose
complete response (CR), partial response (PR), and stable disease (SD)
次要结局
- Progression free survival (PFS)(till study end, estimated 3 years)
- Overall survival (OS)(till study end, estimated 3 years)
研究者
Yeh Chun-Nan
Professor and Chief, Department of Surgery
Chang Gung Memorial Hospital
研究点 (1)
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