对参与其他拜耳研究的实体瘤参与者进行瑞戈非尼持续治疗的研究
瑞戈非尼的单臂、开放标签、多中心 2 期研究，受试者曾在先前拜耳资助的瑞戈非尼研究（单一疗法或联合治疗）中接受过治疗，且已达到主要完成终点或主要数据分析或已停止过早地。
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.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
-
Taichung、台湾、404327
- China Medical University Hospital
-
-
-
-
Saitama
-
Kitaadachi、Saitama、日本、362-0806
- Saitama Cancer Center
-
-
-
-
Hauts-de-France
-
Lille、Hauts-de-France、法国、59000
- CHU Lille - Hopital Claude Huriez - Service Gastro-entrologie adulte
-
-
Île-de-France Region
-
Clichy、Île-de-France Region、法国、92110
- Hôpital Beaujon - Clichy
-
Villejuif、Île-de-France Region、法国、94800
- Hôpital Paul Brousse - Villejuif
-
-
-
-
-
Madrid、西班牙、28009
- Hospital Infantil Universitario Nino Jesus | Oncologia Pediatrica
-
-
-
-
-
Seoul、韩国、03080
- Seoul National University Hospital | Oncology
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Regorafenib
Adult and pediatric patients from completed Bayer-sponsored regorafenib trials who are benefiting from regorafenib treatment. |
Participants will be treated with the regorafenib dose taken during the last cycle of the feeder study. Adult participants will receive either 60, 80, 90, 120, or 160 mg orally (p.o.) once daily (qd) for 3 weeks of every 4-week cycle (i.e. 3 weeks on, 1 week off). Pediatric participants will receive 82 mg/m^2 p.o. qd for 14 days, in a 14 days on/7 days off schedule (21-day cycle). |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
出现严重不良事件 (SAE) 和方案指定 AE 的参与者数量及其严重程度
大体时间：完成学业平均需要 2.5 年
|
完成学业平均需要 2.5 年
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
剂量调整的参与者人数
大体时间：完成学业平均需要 2.5 年
|
完成学业平均需要 2.5 年
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 22551
- 2023-507084-19-00 (注册表标识符：CTIS (EU))
- 2023 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.