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

May 10, 2019 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants receiving/having received Vismodegib for treatment of laBCC according to the German label and in line with the current Summary of Product Characteristics (SmPC) and who have no contraindication to Vismodegib therapy as per the local label are eligible for this non-interventional study if written informed consent is provided.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Drug: Vismodegib
Participants with laBCC will receive a dosing of Vismodegib in accordance with local clinical practice and local labeling.
Other Names:
  • ERIVEDGE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: From first objective response until disease progression or death from any cause, up to 3 years
From first objective response until disease progression or death from any cause, up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Objective Response (CR or PR) as Determined by the Physician
Time Frame: From date of first therapy until disease progression or death, whichever occurs first (up to 3 years)
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)
Time Frame: From date of first therapy until disease progression or death, whichever occurs first (up to 3 years)
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
Time Frame: From date of first therapy until disease progression or death, whichever occurs first (up to 3 years)
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
Time Frame: From the date of first therapy to disease progression or death from any cause, up to 3 years
From the date of first therapy to disease progression or death from any cause, up to 3 years
Overall Survival
Time Frame: From the date of the first therapy to death from any cause, up to 3 years
From the date of the first therapy to death from any cause, up to 3 years
Time to Response
Time Frame: From the date of first therapy to first confirmed CR or PR whichever occurs first, up to 3 years
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
Time Frame: From Baseline up to 3 years
From Baseline up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2015

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29670

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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