Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)

Hoffmann-La Roche67 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Carcinoma, Basal Cell

Interventions

VismodegibDRUG

Participants with laBCC will receive a dosing of Vismodegib in accordance with local clinical practice and local labeling.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: 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)

Locations (1)

Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt, Germany

Outcomes

Primary Outcomes

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

Time frame: From first objective response until disease progression or death from any cause, up to 3 years

Secondary Outcomes

Percentage of Participants with Objective Response (CR or PR) as Determined by the Physician

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: From the date of first therapy to disease progression or death from any cause, up to 3 years

Overall Survival

Time frame: From the date of the first therapy to death from any cause, up to 3 years

Time to Response

Time frame: 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

Time frame: From Baseline up to 3 years

Data from ClinicalTrials.gov

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