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

N/ACompletedNCT02371967

Hoffmann-La Roche50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Basal Cell Carcinoma

Interventions

VismodegibDRUG

Vismodegib therapy will be given in compliance with the physician's standard practice as per local label.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

SU/Sahlgrenska, Hudkliniken

Gothenburg, Sweden

Skånes Universitetssjukhus; Hudkliniken

Lund, Sweden

Radiumhemmet

Solna, Sweden

Norrlands universitetssjukhus; Onkologkliniken

Umeå, Sweden

Outcomes

Primary Outcomes

Percentage of Participants With Clinical Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)

Time frame: 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

Time frame: 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)

Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1

Time frame: 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 who Experience a Recurrence

Time frame: 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

Time frame: 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)

Time frame: From the date of first treatment until death due to any cause (up to approximately 3 years)

Percentage of Participants With Adverse Events

Time frame: From Baseline up to end of study (up to approximately 3 years)

Duration of Vismodegib Treatment

Time frame: Baseline up to approximately 3 years

Percentage of Participants With Vismodegib Treatment Interruption

Data from ClinicalTrials.gov

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