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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-17

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Basal Cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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laBCC Participants

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).

Vismodegib

Intervention Type DRUG

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

Interventions

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Vismodegib

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

Intervention Type DRUG

Other Intervention Names

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ERIVEDGE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No