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Trial record 28 of 78 for:    vismodegib

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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ClinicalTrials.gov Identifier: NCT02674009
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment
Carcinoma, Basal Cell Drug: Vismodegib

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Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

Group/Cohort Intervention/treatment
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
Participants with laBCC will receive a dosing of Vismodegib in accordance with local clinical practice and local labeling.
Other Name: ERIVEDGE




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674009


Locations
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Germany
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt, Germany, 60590
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02674009     History of Changes
Other Study ID Numbers: ML29670
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell