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

Carcinoma, Basal Cell Clinical Trial

— NIELS  

Official title:

Non-Interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions (NIELS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674009
• Other study ID #: ML29670
• Status: Completed
• Start date: September 17, 2015
• Est. completion date: March 31, 2019

Study information

• Verified date: May 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Overall Survival		From the date of the first therapy to death from any cause, up to 3 years
Secondary	Time to Response		From the date of first therapy to first confirmed CR or PR whichever occurs first, up to 3 years
Secondary	Percentage of Participants with Adverse Events		From Baseline up to 3 years