Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions

NCT02781389 | Completed DMC

• 1 other identifier: ML29828
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Keywords

Basal cell carcinoma (BCC); advanced BCC (aBCC)

Outcome Measures

Primary Outcomes (1)

• Primary effectiveness measure: duration of response (partial or complete) until progression, death or up to 3 years from first dose Vismodegib (whichever occurs first)

  The primary effectiveness measure for this study is as follows: • To evaluate the duration of response, defined as duration from first documented complete response (CR) or first documented partial response (PR), whichever cam first, until disease progression (as determined by the treating physician), or death of any reason or up to 3 years from first dose Vismodegib, whichever occurs first, for laBCC patients.

  up to 3 years from first dose Vismodegib

Secondary Outcomes (6)

• Secondary effectiveness measure: - objective response rate

  up to 3 years from first dose Vismodegib

• Secondary effectiveness measure: - time to response

  up to 3 years from first dose Vismodegib

• Secondary effectiveness measure: - disease control rate

  up to 3 years from first dose Vismodegib

• Secondary effectiveness measure: - recurrence rate

  up to 3 years from first dose Vismodegib

• Secondary effectiveness measure: - time to progression

  up to 3 years from first dose Vismodegib

Other Outcomes (7)

• Explorative outcome measures: tumor response

  up to 3 years from first dose Vismodegib

• Explorative outcome measures: treatment decision for therapy with Vismodegib

  up to 3 years from first dose Vismodegib

• Explorative outcome measures: previous treatment

  up to 3 years from first dose Vismodegib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

53 Patients with locally advanced BCC who are being treated with Vismodegib will be followed prospectively by centers across Germany and clinical course will be documented

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Essen: lead
• OnkoDataMed GmbH: collaborator

Study Sites (1)

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

Essen, 45122, Germany

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Dirk Schadendorf, Professor

  Universitätsklinikum Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: April 24, 2016
• First Posted: May 24, 2016
• Study Start: April 29, 2016
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)