Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions

NCT ID: NCT02781389

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-29
• Study Completion Date: 2021-05-31

Brief Summary

The aim of this non-interventional study is to provide further data on the utilization, effectiveness, safety and clinical benefit including duration of response of Vismodegib for treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or radiotherapy under real world clinical conditions.

Detailed Description

This is a multi-center non-interventional study with 53 patients with locally advanced BCC who start Vismodegib (received at least one dose) in Q4 2015. Duration of recruitment will be one year. Patients will be followed prospectively until disease progression, death, or for 3 years from first dose Vismodegib (whichever occurs first).

The primary effectiveness objective for this study is as follows:

• 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, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment) for laBCC patients.

The secondary effectiveness objectives for this study are as follows:

• Objective response rate (rate of patients with CR or PR) (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment)
• Disease control rate (complete response (CR), partial response (PR) or stable disease (SD))
• Recurrence rate: rate of patients who responded (CR or PR) and later progressed
• Time to progression: time from first treatment to progression
• Time to death: time from first treatment to death
• Time to response: time from first treatment to response

The explorative objectives of this study are to evaluate the following endpoints:

• Type of tumor response evaluation (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment , histological assessment, imaging assessment)
• Treatment decision for therapy with Vismodegib (tumor board OR decision by otorhinolaryngologist, surgeon, plastic surgeon, dermato-oncologist, radiotherapist, ophthalmologist)
• Utilization

• Previous treatment for the BCC lesion, which led to therapy with Vismodegib
• BCC therapy after Vismodegib therapy (if applicable)
• Treatment duration of Vismodegib (start and stop dates for therapy with Vismodegib)
• Assessment of duration and time point of treatment interruptions of Vismodegib
• Reason for treatment discontinuation

Conditions

Basal Cell Carcinoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Willing and able to provide informed consent
• Age ≥ 18 years
• laBCC (inappropriate for surgery or radiotherapy)
• Patient is not included in any other trial
• Male or female patient is included in the pregnancy prevention program, as determined by the German authority (BfArM)

Exclusion Criteria

Patients, for whom treatment with Vismodegib is contraindicated according to the Summary of Product Characteristics (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 listed in section 6.1. of the latest SmPC
• Women who are pregnant or breast-feeding
• Women of childbearing potential who do not comply with the Vismodegib (Erivedge) Pregnancy Prevention Programme
• Coadministration of St John's wort (Hypericum perforatum)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OnkoDataMed GmbH

INDUSTRY

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Dirk Schadendorf

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk Schadendorf, Professor

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Essen

Locations

Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie (Universitätsklinikum Essen)

Essen, , Germany

Countries

Germany

Other Identifiers

ML29828

Identifier Type: -

Identifier Source: org_study_id