A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)

Completed

• Conditions: Basal Cell Carcinoma
• Interventions: Drug: Vismodegib

• Registration Number: NCT02371967
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Study Start: 2015-04-08
• Primary Completion: 2020-08-19
• Study Completion: 2020-08-19
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-08
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Gorlin Syndrome Participants With No Prior HPI Exposure	Vismodegib	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.
No Gorlin Syndrome Participants With Prior HPI Exposure	Vismodegib	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.
Gorlin Syndrome Participants With/Without Prior HPI Exposure	Vismodegib	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.

Primary Outcome Measures

Name	Time	Method
Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1	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)	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	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	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	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)	From the date of first treatment until death due to any cause (up to approximately 3 years)
Percentage of Participants With Adverse Events	From Baseline up to end of study (up to approximately 3 years)
Duration of Vismodegib Treatment	Baseline up to approximately 3 years
Percentage of Participants With Vismodegib Treatment Interruption	Baseline up to approximately 3 years

Trial Locations

Locations (4)

Skånes Universitetssjukhus; Hudkliniken; 🇸🇪 Lund, Sweden

SU/Sahlgrenska, Hudkliniken; 🇸🇪 Göteborg, Sweden

Norrlands universitetssjukhus; Onkologkliniken; 🇸🇪 Umeå, Sweden

Radiumhemmet; 🇸🇪 Solna, Sweden