Non-interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Primary effectiveness measure: duration of response (partial or complete) until progression, death or up to 3 years from first dose Vismodegib (whichever occurs first)
研究概览
简要总结
The aim of this non-interventional study is to provide further data on the utilization, effectiveness, safety and clinical benefit including duration of response of Vismodegib for treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or radiotherapy under real world clinical conditions.
详细描述
This is a multi-center non-interventional study with 53 patients with locally advanced BCC who start Vismodegib (received at least one dose) in Q4 2015. Duration of recruitment will be one year. Patients will be followed prospectively until disease progression, death, or for 3 years from first dose Vismodegib (whichever occurs first).
The primary effectiveness objective for this study is as follows:
• To evaluate the duration of response defined as duration from first documented response of complete response (CR) or partial response (PR) until disease progression (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment) for laBCC patients.
The secondary effectiveness objectives for this study are as follows:
- Objective response rate (rate of patients with CR or PR) (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment)
- Disease control rate (complete response (CR), partial response (PR) or stable disease (SD))
- Recurrence rate: rate of patients who responded (CR or PR) and later progressed
- Time to progression: time from first treatment to progression
- Time to death: time from first treatment to death
- Time to response: time from first treatment to response
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Willing and able to provide informed consent
- •Age ≥ 18 years
- •laBCC (inappropriate for surgery or radiotherapy)
- •Patient is not included in any other trial
- •Male or female patient is included in the pregnancy prevention program, as determined by the German authority (BfArM)
排除标准
- •Patients, for whom treatment with Vismodegib is contraindicated according to the Summary of Product Characteristics (SmPC), which has been in effect at the time of treatment with Vismodegib, including:
- •Hypersensitivity to the active substance or to any of the excipients listed in section 6.
- •of the latest SmPC
- •Women who are pregnant or breast-feeding
- •Women of childbearing potential who do not comply with the Vismodegib (Erivedge) Pregnancy Prevention Programme
- •Coadministration of St John's wort (Hypericum perforatum)
结局指标
主要结局
Primary effectiveness measure: duration of response (partial or complete) until progression, death or up to 3 years from first dose Vismodegib (whichever occurs first)
时间窗: up to 3 years from first dose Vismodegib
The primary effectiveness measure for this study is as follows: • To evaluate the duration of response, defined as duration from first documented complete response (CR) or first documented partial response (PR), whichever cam first, until disease progression (as determined by the treating physician), or death of any reason or up to 3 years from first dose Vismodegib, whichever occurs first, for laBCC patients.
次要结局
- Secondary effectiveness measure: - time to response(up to 3 years from first dose Vismodegib)
- Secondary effectiveness measure: - survival(up to 3 years from first dose Vismodegib)
- Secondary effectiveness measure: - recurrence rate(up to 3 years from first dose Vismodegib)
- Secondary effectiveness measure: - disease control rate(up to 3 years from first dose Vismodegib)
- Secondary effectiveness measure: - objective response rate(up to 3 years from first dose Vismodegib)
- Secondary effectiveness measure: - time to progression(up to 3 years from first dose Vismodegib)
研究者
Prof. Dr. med. Dirk Schadendorf
Prof. Dr. med.
University Hospital, Essen