An Open-label, Multicenter Rollover Study to Provide Continued Treatment With Anetumab Ravtansine for Participants With Solid Tumors Who Were Enrolled in Previous Bayer-sponsored Studies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 9
- 试验地点
- 7
- 主要终点
- Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs
研究概览
简要总结
The purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. The patients will be observed to collect information on how safe and efficient the drug is.
详细描述
The primary objective of the study is to collect long-term safety information on anetumab ravtansine and to enable patients, who received an anetumab ravtansine-containing treatment in any Bayer-sponsored anetumab ravtansine parent study, to continue the treatment. The secondary objective is to further investigate the efficacy of the drug.
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 ongoing in an applicable Bayer-sponsored anetumab ravtansine parent study at the time of its planned study closure.
- •For on-treatment participants: participant is eligible to receive the next dose of study intervention per the parent study protocol.
- •For on-treatment participants: 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. For applicable studies: should treatment be permanently interrupted in the parent study, participants may be enrolled in the follow-up portion of the rollover study.
排除标准
- •For on-treatment participants: a positive serum pregnancy test.
- •For on-treatment participants: use of one or more of the prohibited medications listed in the respective parent study protocol.
- •Participants who are receiving standard-of-care agent(s) but not anetumab ravtansine in the parent study, and are able to receive standard-of-care agent outside of the clinical study.
研究组 & 干预措施
Cancer patients
Adult patients with solid cancer who received anetumab-ravtansine treatment in a completed Bayer study
干预措施: BAY94-9343 (Anetumab ravtansine) (Drug)
结局指标
主要结局
Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs
时间窗: Approximately 3 years (from first study treatment until safety follow-up)
Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events.
次要结局
- Overall Survival(Approximately 3 years (from first study treatment until safety follow-up))