NCT05017662已完成不适用
A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants Who Have Been Previously Treated With 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Proportion of participants with second primary haematological and non-haematological malignancies.
研究概览
简要总结
The purpose of the protocol is to evaluate the long-term safety of medicine 177Lu-satoreotide tetraxetan (also known as 177Lu-IPN01072 or 177Lu-OPS201) for patients who have previously received 177Lu-satoreotide tetraxetan in the clinical study OPS-C-001 / D-FR-01072-001.
详细描述
The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection includes assessments/blood collection and on-site visits not necessarily part of routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Participant is capable of giving signed informed consent
- •Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C-001
排除标准
- •- There are no exclusion criteria in this safety surveillance study.
研究组 & 干预措施
Data collection
Other
干预措施: Data collection (Other)
结局指标
主要结局
Proportion of participants with second primary haematological and non-haematological malignancies.
时间窗: During the whole study period (approximately 5 years).
次要结局
- Changes over time in laboratory tests (biochemistry)(During the whole study period (approximately 5 years).)
- Proportion of treatment-related adverse events of any grade.(During the whole study period (approximately 5 years).)
- Changes over time in laboratory tests (haematology)(During the whole study period (approximately 5 years).)
- Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause.(During the whole study period (approximately 5 years).)
研究者
研究点 (7)
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