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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02674009 |
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Date of registration:
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02/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)
NIELS |
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Scientific title:
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Non-Interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions (NIELS) |
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Date of first enrolment:
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September 17, 2015 |
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Target sample size:
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67 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02674009 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Carcinoma, Basal Cell
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Intervention(s)
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Drug: Vismodegib
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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)]
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Percentage of Participants with Adverse Events
[Time Frame: From Baseline up to 3 years]
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Overall Survival
[Time Frame: From the date of the first therapy to death from any cause, up to 3 years]
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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]
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Time to Response
[Time Frame: From the date of first therapy to first confirmed CR or PR whichever occurs first, up to 3 years]
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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)]
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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)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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