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Completed

NCT Number: NCT02674009

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

vismodegib

Drug

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

Other names: ERIVEDGE

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. Overall Survival

    Time frame: From the date of the first therapy to death from any cause, up to 3 years

  6. Time to Response

    Time frame: From the date of first therapy to first confirmed CR or PR whichever occurs first, up to 3 years

  7. Percentage of Participants with Adverse Events

    Time frame: From Baseline up to 3 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: NIELS

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2016
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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