A Roll-over Study to Provide Continued Treatment With Rogaratinib in Participants Who Were Enrolled in Rogaratinib Studies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Incidence of drug-related TEAEs
研究概览
简要总结
The purpose of this study is to enable patients, who are currently receiving rogaratinib in a Bayer-sponsored clinical trial (incl. NCT01976741), to continue treatment after their respective study has been closed. Another aim is to learn if rogaratinib is safe and how it affects the body.
Rogaratinib is an investigational drug that may treat different types of cancer, incl. non-small-cell lung cancer, small-cell lung cancer, urothelial carcinoma, head, neck and breast cancer. The drug may stop the growth of cancer cells by targeting different cell proteins called fibroblast growth factor receptors (FGFR) that are needed for the survival of the cancer cells.
详细描述
The primary objectives of the study are the continuation of rogaratinib treatment (as monotherapy or combination therapy) for patients after closure of their feeder studies and the further assessment of the safety of the drug.
The secondary objective is to investigate the tolerability of rogaratinib.
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
- •Participants enrolled in any Bayer-sponsored rogaratinib feeder study at the time of study closure, who are currently receiving rogaratinib (monotherapy or combination therapy) and are experiencing clinical benefit from treatment, determined by the treating physician.
- •Participants who meet criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder study protocol.
- •Any ongoing adverse events that required temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption.
- •Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study treatment and until 6 months after stopping study treatment.
排除标准
- •Ineligibility, for medical reasons, to start the next treatment cycle in the respective feeder study.
- •Patients with a beta-human chorionic gonadotropin (hCG) test consistent with pregnancy.
- •Participants are using one or more of the prohibited medications listed in the respective feeder study protocol
- •Negative benefit / risk ratio as determined by the investigator
- •Positive pregnancy test for on-treatment participants
研究组 & 干预措施
Cancer patients
Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.
干预措施: Rogaratinib (BAY1163877) (Drug)
Cancer patients
Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.
干预措施: Combination drug (Drug)
结局指标
主要结局
Incidence of drug-related TEAEs
时间窗: Up to 55 months
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 55 months
Incidence of treatment-emergent serious adverse events (TESAEs)
时间窗: Up to 55 months
Incidence of drug-related TESAEs
时间窗: Up to 55 months
次要结局
- Frequency of dose modifications(Up to 55 months)