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

NCT02674009 | Completed

• 1 other identifier: ML29670
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Basal Cell

Outcome Measures

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

  From first objective response until disease progression or death from any cause, up to 3 years

Secondary Outcomes (7)

• 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)

• 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)

• 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)

• 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

• Overall Survival

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

Study Arms (1)

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

Interventions

Vismodegib DRUG

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

Also known as: ERIVEDGE

laBCC Participants

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

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

Frankfurt, 60590, Germany

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

HhAntag691

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 4, 2016
• Study Start: September 17, 2015
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

DE (1)