A Single Arm, Open-label, Multicenter Phase 2 Study of Regorafenib in Participants Who Have Been Treated in a Previous Bayer-sponsored Regorafenib Study (Monotherapy or Combination Treatment) That Has Reached the Primary Completion Endpoint or the Main Data Analysis or Has Been Stopped Prematurely.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 13
- 试验地点
- 7
- 主要终点
- Number of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity
研究概览
简要总结
Regorafenib is an anti-cancer drug that blocks several proteins which are involved in the growth of cancer. It has been approved for different types of cancers of the digestive system and is being tested for use in some other solid tumors. Cancers that start in an organ, a muscle, or a bone form a solid tumor.
This study is for participants with solid tumors who have been taking regorafenib in other Bayer studies. They can continue taking regorafenib if it is working when treatment with regorafenib in their previous study ends.
The main purpose of this study is to find:
- How safe is the continued treatment with regorafenib in participants with solid tumors?
- How well is the continued treatment with regorafenib tolerated by participants with solid tumors?
Participants will continue with the same dose of regorafenib that they were taking in their previous study as long as the treatment works for them/they want to continue the treatment/other medical conditions do not prevent them from participating in the study. For participants that are under 18 years of age, regorafenib tablets will be taken by mouth once daily for 2 weeks and repeat again after a 1-week gap. For participants that are over 18 years of age, regorafenib tablets will be taken by mouth once daily for 3 weeks and repeat again after a 1-week gap.
At the start of the study, researchers will review participants' records from the previous study. During the study, researchers will use blood samples and X-rays taken from participants under the age of 18 years to check how safe regorafenib is for children. They will also monitor any medical problems that participants may have during the study. After the last dose, follow-up will be done either within 14 days when participants visit their study doctor or within 30-35 days by phone call.
Both the researchers and the participants will know the dose of regorafenib the participants receive during the study.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving regorafenib as study treatment.
- •Participant is currently benefiting from treatment with regorafenib monotherapy. All participants must meet criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
- •Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.
排除标准
- •Ineligibility, for medical reasons, to start the subsequent cycle in the respective feeder study.
- •Participants with a beta-human chorionic gonadotropin (hCG) test result consistent with pregnancy.
- •Participants are using one or more of the prohibited medications listed in the respective feeder study protocol.
- •Participant has been previously permanently discontinued from regorafenib treatment.
研究组 & 干预措施
Regorafenib
Adult and pediatric patients from completed Bayer-sponsored regorafenib trials who are benefiting from regorafenib treatment.
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
结局指标
主要结局
Number of participants with serious adverse events (SAEs) and protocol-specified AEs and their severity
时间窗: through study completion, an average of 2.5 year
次要结局
- Number of participants with dose modifications(through study completion, an average of 2.5 year)