A Prospective Observational Study of Erivedge® Treatment, Effectiveness, and Safety Outcomes in Patients With Advanced Basal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1
研究概览
简要总结
This prospective, observational, cohort study is designed to assess the effectiveness and safety outcomes of vismodegib and to assess actual day-to-day disease and participant management by the physician.
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
- •BCC that meets one of the study's pre-specified cohort definitions
- •Physician's decision to treat participant with vismodegib as per local label
- •Participant who has not participated in a clinical trial within 90 days prior to study enrollment, with the exception of participants who meet the criteria for Cohort 2 (No Gorlin Syndrome Participants With Prior HPI Exposure)
排除标准
- •Female participants are excluded if they are pregnant or if they plan to become pregnant during treatment or within 2 years after end of treatment
- •Male participants with female partners of childbearing potential are excluded if they plan to impregnate their partner during treatment or within 2 months after end of treatment
研究组 & 干预措施
No Gorlin Syndrome Participants With No Prior HPI Exposure
BCC participants with advanced disease and no Gorlin syndrome, and who have not been exposed previously to an Hedgehog Pathway Inhibitor (HPI) (e.g., Vismodegib, LDE225) prior to diagnosis of advanced disease; will receive vismodegib therapy in compliance with the physician's standard practice as per local label and will be followed-up for approximately 3 years or until death, withdrawal of consent, sponsor's decision, lost to follow-up or end of study.
干预措施: Vismodegib (Drug)
No Gorlin Syndrome Participants With Prior HPI Exposure
BCC participants with advanced disease and no Gorlin syndrome, and who have been exposed previously to an HPI (e.g., during clinical studies with vismodegib [SHH4476g {NCT00833417}, MO25616 {NCT01367665}] or LDE225); will receive vismodegib therapy in compliance with the physician's standard practice as per local label and will be followed-up for approximately 3 years or until death, withdrawal of consent, sponsor's decision, lost to follow-up or end of study.
干预措施: Vismodegib (Drug)
Gorlin Syndrome Participants With/Without Prior HPI Exposure
BCC participants with advanced disease and Gorlin syndrome, and who have or have not been previously exposed to an HPI (e.g., during clinical studies); will receive vismodegib therapy in compliance with the physician's standard practice as per local label and will be followed-up for approximately 3 years or until death, withdrawal of consent, sponsor's decision, lost to follow-up or end of study.
干预措施: Vismodegib (Drug)
结局指标
主要结局
Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1
时间窗: From the date of occurrence of first clinical response up to the date of progression or death from any cause (up to approximately 3 years)
Percentage of Participants With Clinical Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
时间窗: From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
Time to Clinical Response as Assessed by Investigator According to RECIST v1.1
时间窗: From the date of first treatment until the date of first documented confirmed complete response (CR) or partial response (PR) (whichever occurs first) (up to approximately 3 years)
Percentage of Participants who Experience a Recurrence
时间窗: From Baseline up to end of study (up to approximately 3 years)
Progression-Free Survival (PFS) as Assessed by Investigator According to RECIST v1.1
时间窗: From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
Overall survival (OS)
时间窗: From the date of first treatment until death due to any cause (up to approximately 3 years)
Percentage of Participants With Adverse Events
时间窗: From Baseline up to end of study (up to approximately 3 years)
Duration of Vismodegib Treatment
时间窗: Baseline up to approximately 3 years
Percentage of Participants With Vismodegib Treatment Interruption
时间窗: Baseline up to approximately 3 years
次要结局
未报告次要终点