NCT02465502已完成2 期
An Uncontrolled, Open-label Phase IIb Trial of Regorafenib in Subjects With Antiangiogenic-naive and Chemotherapy-refractory Advanced Colorectal Cancer
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
- Bayer
- 入组人数
- 59
- 主要终点
- Percentage of participants without disease progression or death at the end of 8 weeks
研究概览
简要总结
To determine the efficacy (as measured by progression-free survival [PFS] rate at 8 weeks) of regorafenib in subjects with metastatic colorectal cancer (CRC) whose disease is refractory to standard therapies and who were never exposed to antiangiogenic therapy.
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
- •Male or female subjects ≥18 years of age;
- •Histological or cytological confirmation of adenocarcinoma of the colon or/and rectum;
- •Subjects with metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to standard chemotherapy based on fluoropyrimidine, oxaliplatin, irinotecan, and an anti-EGFR therapy if RAS wild-type. This progression must be during or within 4 months following the last administration of standard therapies.
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate bone-marrow, liver, and renal function
- •Women of childbearing potential and men must agree to use adequate contraception when sexually active during the study and for at least 8 weeks after the last study drug administration.
排除标准
- •Prior treatment with an antiangiogenic agent;
- •Congestive heart failure of New York Heart Association (NYHA) class 2 or worse;
- •Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug;
- •Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- •Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite optimal medical management);
- •Ongoing acute or chronic infection (> Grade 2 NCI-CTCAE v 4.03);
- •Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication) events within 6 months of study enrollment. Subjects being treated with low-weight heparin are allowed to participate as long as dose is limited to prophylactic use.
- •Any history of or currently known brain metastases (head CT/MRI will be performed during screening period if brain metastases are suspected)
- •Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years before study entry, except for curatively treated cervical cancer in situ, in situ ductal breast cancer, non-melanoma skin cancer and superficial bladder tumors;
- •Last chemotherapy dose or any other anti-cancer therapy administered in less than 4 weeks from start of study treatment;
- •Use of therapeutic anticoagulation;
- •Proteinuria > 3.5 g/24 hours measured by urine protein-creatinine ratio from a random urine sample (Grade 3, NCI-CTCAE v 4.03) on urinalysis screening result. If there is medical history of proteinuria, previous urinalysis results should be considered and/or performed so at least 2 results separated by at least 2 weeks are available;
- •History of interstitial lung disease with ongoing signs and symptoms at the time of informed consent;
- •Non-healing wound, non-healing ulcer, or non-healing bone fracture;
- •Subjects with evidence or history of any bleeding diathesis, irrespective of severity;
- •Any hemorrhage or bleeding event ≥ Grade 3 NCI-CTCAE v 4.03 within 4 weeks prior to the start of study medication;
- •Known history of human immunodeficiency virus (HIV) infection;
- •History of active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy;
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Regorafenib (BAY73-4506)
Experimental
Regorafenib 160 mg orally once a day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
结局指标
主要结局
Percentage of participants without disease progression or death at the end of 8 weeks
时间窗: At week 8
次要结局
- Metabolic response measured by [18F] fluorodeoxyglucose positron emission tomography (FDG PET)(Approximately 2 months)
- Overall Response Rate (ORR)(Approximately 2 months)
- Overall Survival (OS)(Approximately 2 months)
- Progression-Free Survival (PFS)(Approximately 2 months)
- Disease Control Rate (DCR)(Approximately 2 months)
- Percentage of participants with grade 1 or higher adverse events, using NCI Common Terminology Criteria for Adverse Events (CTC-AE) Version 4.03(Approximately 2 months)
研究者
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