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

Completed

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

• Registration Number: NCT02674009
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-17
• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-04
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laBCC Participants	Vismodegib	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie; 🇩🇪 Frankfurt, Germany