An observational study in Carcinoma, Basal Cell, sponsored by Hoffmann-La Roche. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by Hoffmann-La Roche · Observational
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 67 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
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.
Also known as: ERIVEDGE
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
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)
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)
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)
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
Overall Survival
Time frame: 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
Percentage of Participants with Adverse Events
Time frame: From Baseline up to 3 years
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche