NCT02674009已完成不适用
Non-Interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions (NIELS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Duration of Response, Defined as the Time from the First Assessment of CR or PR until Disease Progression or Death from any Cause, Whichever Occurs First
研究概览
简要总结
The primary purpose for this multi-center, non-interventional study is 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) for participants with laBCC.
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
- •Histologically confirmed IaBCC (inappropriate for surgery or radiotherapy)
- •Participant is not included in any other trial
- •Male or female participants are included in the pregnancy prevention program
排除标准
- •Participants for whom treatment with Vismodegib is contraindicated according to the 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
- •Women who are pregnant or breastfeeding
- •Women of childbearing potential who do not comply with the Vismodegib Pregnancy Prevention Programme
- •Coadministration of St John's wort (Hypericum perforatum)
研究组 & 干预措施
laBCC Participants
Participants with laBCC who received at least one dose of Vismodegib in routine clinical practice for 32 months (between 02 Aug 2013 and 31 Mar 2016).
干预措施: Vismodegib (Drug)
结局指标
主要结局
Duration of Response, Defined as the Time from the First Assessment of CR or PR until Disease Progression or Death from any Cause, Whichever Occurs First
时间窗: From first objective response until disease progression or death from any cause, up to 3 years
次要结局
- Percentage of Participants with Objective Response (CR or PR) as Determined by the Physician(From date of first therapy until disease progression or death, whichever occurs first (up to 3 years))
- Percentage of Participants with Disease Control (CR, PR, or Stable Disease)(From date of first therapy until disease progression or death, whichever occurs first (up to 3 years))
- Percentage of Participants with Disease Reccurence, Defined as Participants who Achieve CR and later Progress(From date of first therapy until disease progression or death, whichever occurs first (up to 3 years))
- Progression-Free Survival, Evaluated According to Physician's Assessments(From the date of first therapy to disease progression or death from any cause, up to 3 years)
- Overall Survival(From the date of the first therapy to death from any cause, up to 3 years)
- Time to Response(From the date of first therapy to first confirmed CR or PR whichever occurs first, up to 3 years)
- Percentage of Participants with Adverse Events(From Baseline up to 3 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Eslicarbazepine Acetate as Add-On Treatment to One Baseline Antiepileptic Drug (ESLADOBA)EpilepsyNCT01532726Bial - Portela C S.A.56
已完成
不适用
A Multicenter, Prospective, oBservational Study to assEss the Clinical activitY and Impact on symptOm Burden and patieNts' HRQoL of Treatment With trabecteDin in aSTS in a Real World Setting in GreeceAdvanced Soft Tissue SarcomaNCT02618122Genesis Pharma S.A.63
撤回
不适用
A Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in IndiaHeart FailureNCT02047526AstraZeneca
已完成
不适用
Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in AustriaRheumatoid ArthritisNCT01877239Pfizer111
进行中（未招募）
不适用
Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's SyndromeEndogenous Cushing's SyndromeNCT05382156RECORDATI GROUP206