A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 100
- 试验地点
- 13
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This is a Phase IV, single-arm, prospective, open-label, multicenter, interventional study to evaluate safety and efficacy of regorafenib in patients with mCRC who have been previously treated with fluoropyrimidine , oxaliplatin-, and irinotecan based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR 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 patients (≥18 years of age) with metastatic (Stage IV) colorectal adenocarcinoma confirmed either histologically or cytologically, with measurable metastatic disease according to RECIST v. 1.1
- •Patients must have PD after receiving the approved standard therapies
- •Patients must have ECOG PS of 0 or 1 and a life expectancy of at least 3 months
- •Adequate bone marrow, liver and renal function
- •Women of childbearing potential and men must agree to use adequate contraception
排除标准
- •Unresolved toxicity greater than Grade 1 from prior treatment for mCRC
- •Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s)
- •Subjects unable to swallow oral medications
- •Any malabsorption condition
- •Any medical or surgical conditions within 28 days before start of regorafenib that will interfere with patient's participation in the study
研究组 & 干预措施
Regorafenib (Stivarga, BAY 73-4506)
Patients with metastatic colorectal cancer
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
时间窗: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements
时间窗: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body weight (kg)
时间窗: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body height (cm)
时间窗: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Systolic / Diastolic BP (mmHg)
时间窗: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in heart rate (beats/min)
时间窗: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
次要结局
- Disease control rate (DCR)(In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first)
- Overall survival (OS)(In each participant, every 8 weeks from the start of regorafenib until death, lost to follow-up, consent withdrawn or end of study, whichever occurs first)
- Overall response rate (ORR)(In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first)
- Progression free survival (PFS)(In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first)