A Non-interventional, Multi-national, Multi-center Post-authorization Safety Study (PASS) to Assess the Long Term Safety and Tolerability of Odomzo (Sonidegib) Administered in Patients With Locally Advanced Cell Carcinoma (laBCC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 47
- 主要终点
- Proportion of patients with AEs/SAEs
研究概览
简要总结
Collect real world safety data on the use of sonidegib in adult patients with laBCC. Document major safety parameters such as on treatment deaths, adverse events (AEs)/ serious adverse events (SAEs) and discontinuation secondary to AEs.
详细描述
This is a non-interventional, multinational, multi-center post-authorization safety study (PASS), to assess the safety of sonidegib administered in routine clinical practice in patients with laBCC who are not amendable to curative surgery or radiation therapy. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a specific visit schedule. For this study, each enrolled patient will be followed up for 3 years after enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent or equivalent document (e.g., written information) as per country regulation
- •Patients aged 18 years or older with a diagnosis of laBCC who are not amenable to curative surgery or radiation therapy
- •Patients must be treated with sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
- •Sonidegib treatment must be started either at the first visit for this study or prior to study entry.
排除标准
- •Patients treated with any hedgehog pathway inhibitor besides sonidegib within 3 months prior to study entry
- •Patients currently enrolled in an interventional clinical trial
- •Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC)
- •Pregnancy and breast-feeding
- •Women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (as defined in sections 4.4 and 4.6 of the approved SmPC).
- •Male patients who are unable to follow or comply with the required contraception measures (as defined in sections 4.4 and 4.6 of the approved SmPC).
研究组 & 干预措施
Sonidegib
Patients with laBCC undergoing sonidegib treatment in routine clinical practice
干预措施: sonidegib (Drug)
结局指标
主要结局
Proportion of patients with AEs/SAEs
时间窗: 3 years
including on-treatment deaths and discontinuation due to AEs/SAEs
次要结局
- Proportion of patients with AEs of special interest (AESI) or populations(3 years)