Clinical trial NCT02674009: Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Basal Cell
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: From first objective response until disease progression or death from any cause, up to 3 years
Secondary outcomes:
measure: Percentage of Participants with Objective Response (CR or PR) as Determined by the Physician
timeFrame: From date of first therapy until disease progression or death, whichever occurs first (up to 3 years)
measure: Percentage of Participants with Disease Control (CR, PR, or Stable Disease)
timeFrame: From date of first therapy until disease progression or death, whichever occurs first (up to 3 years)
measure: Percentage of Participants with Disease Reccurence, Defined as Participants who Achieve CR and later Progress
timeFrame: From date of first therapy until disease progression or death, whichever occurs first (up to 3 years)
measure: Progression-Free Survival, Evaluated According to Physician's Assessments
timeFrame: From the date of first therapy to disease progression or death from any cause, up to 3 years
measure: Overall Survival
timeFrame: From the date of the first therapy to death from any cause, up to 3 years
measure: Time to Response
timeFrame: From the date of first therapy to first confirmed CR or PR whichever occurs first, up to 3 years
measure: Percentage of Participants with Adverse Events
timeFrame: From Baseline up to 3 years
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: