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Trial record 51 of 78 for:    vismodegib

Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions (JONAS)

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ClinicalTrials.gov Identifier: NCT02781389
Recruitment Status : Active, not recruiting
First Posted : May 24, 2016
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
OnkoDataMed GmbH
Information provided by (Responsible Party):
Prof. Dr. med. Dirk Schadendorf, University Hospital, Essen

Brief Summary:
The aim of this non-interventional study is to provide further data on the utilization, effectiveness, safety and clinical benefit including duration of response of Vismodegib for treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or radiotherapy under real world clinical conditions.

Condition or disease
Basal Cell Carcinoma

Detailed Description:

This is a multi-center non-interventional study with 53 patients with locally advanced BCC who start Vismodegib (received at least one dose) in Q4 2015. Duration of recruitment will be one year. Patients will be followed prospectively until disease progression, death, or for 3 years from first dose Vismodegib (whichever occurs first).

The primary effectiveness objective for this study is as follows:

• 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, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment) for laBCC patients.

The secondary effectiveness objectives for this study are as follows:

  • Objective response rate (rate of patients with CR or PR) (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment)
  • Disease control rate (complete response (CR), partial response (PR) or stable disease (SD))
  • Recurrence rate: rate of patients who responded (CR or PR) and later progressed
  • Time to progression: time from first treatment to progression
  • Time to death: time from first treatment to death
  • Time to response: time from first treatment to response

The explorative objectives of this study are to evaluate the following endpoints:

  • Type of tumor response evaluation (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment , histological assessment, imaging assessment)
  • Treatment decision for therapy with Vismodegib (tumor board OR decision by otorhinolaryngologist, surgeon, plastic surgeon, dermato-oncologist, radiotherapist, ophthalmologist)
  • Utilization

    • Previous treatment for the BCC lesion, which led to therapy with Vismodegib
    • BCC therapy after Vismodegib therapy (if applicable)
    • Treatment duration of Vismodegib (start and stop dates for therapy with Vismodegib)
    • Assessment of duration and time point of treatment interruptions of Vismodegib
    • Reason for treatment discontinuation

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Control
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
Actual Study Start Date : April 29, 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021



Primary Outcome Measures :
  1. Primary effectiveness measure: duration of response (partial or complete) until progression, death or up to 3 years from first dose Vismodegib (whichever occurs first) [ Time Frame: up to 3 years from first dose Vismodegib ]

    The primary effectiveness measure for this study is as follows:

    • To evaluate the duration of response, defined as duration from first documented complete response (CR) or first documented partial response (PR), whichever cam first, until disease progression (as determined by the treating physician), or death of any reason or up to 3 years from first dose Vismodegib, whichever occurs first, for laBCC patients.



Secondary Outcome Measures :
  1. Secondary effectiveness measure: - objective response rate [ Time Frame: up to 3 years from first dose Vismodegib ]
    number of patients with complete response or partial response as determined by the treating physician by clinical assessment, histological assessment, imaging assessment

  2. Secondary effectiveness measure: - time to response [ Time Frame: up to 3 years from first dose Vismodegib ]
    time from first dose Vismodegib to complete response or partial response up to 3 years

  3. Secondary effectiveness measure: - disease control rate [ Time Frame: up to 3 years from first dose Vismodegib ]
    number of complete response, partial response, stable disease

  4. Secondary effectiveness measure: - recurrence rate [ Time Frame: up to 3 years from first dose Vismodegib ]
    number of patients who responded (partial or complete) and later progressed

  5. Secondary effectiveness measure: - time to progression [ Time Frame: up to 3 years from first dose Vismodegib ]
    time from first dose Vismodegib to progression up to 3 years

  6. Secondary effectiveness measure: - survival [ Time Frame: up to 3 years from first dose Vismodegib ]
    time from first dose Vismodegib to death of any cause


Other Outcome Measures:
  1. Explorative outcome measures: tumor response [ Time Frame: up to 3 years from first dose Vismodegib ]
    - type of tumor response as determined by the treating physician by clinical assessment and/or histological assessment and/or imaging assessment

  2. Explorative outcome measures: treatment decision for therapy with Vismodegib [ Time Frame: up to 3 years from first dose Vismodegib ]
    - treatment decision for therapy with Vismodegib by tumor board OR by otorhinolaryngologist, surgeon, plastic surgeon, dermato-oncologist, radiotherapist, ophthalmologist

  3. Explorative outcome measures: previous treatment [ Time Frame: up to 3 years from first dose Vismodegib ]
    - previous treatment for the BCC lesion, which led to therapy with Vismodegib

  4. Explorative outcome measures: therapy after Vismodegib [ Time Frame: up to 3 years from first dose Vismodegib ]
    - BCC therapy after Vismodegib therapy

  5. Explorative outcome measures: duration of therapy with Vismodegib [ Time Frame: up to 3 years from first dose Vismodegib ]
    - time of treatment with Vismodegib

  6. Explorative outcome measures: Vismodegib therapy interruptions [ Time Frame: up to 3 years from first dose Vismodegib ]
    - time to treatment interruptions of Vismodegib

  7. Explorative outcome measures: Vismodegib treatment discontinuation [ Time Frame: up to 3 years from first dose Vismodegib ]
    - reason for treatment discontinuation of Vismodegib



Information from the National Library of Medicine

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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
53 Patients with locally advanced BCC who are being treated with Vismodegib will be followed prospectively by centers across Germany and clinical course will be documented
Criteria

Inclusion Criteria:

  • Willing and able to provide informed consent
  • Age ≥ 18 years
  • laBCC (inappropriate for surgery or radiotherapy)
  • Patient is not included in any other trial
  • Male or female patient is included in the pregnancy prevention program, as determined by the German authority (BfArM)

Exclusion Criteria:

Patients, for whom treatment with Vismodegib is contraindicated according to the Summary of Product Characteristics (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 listed in section 6.1. of the latest SmPC
  • Women who are pregnant or breast-feeding
  • Women of childbearing potential who do not comply with the Vismodegib (Erivedge) 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): NCT02781389


Locations
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Germany
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie (Universitätsklinikum Essen)
Essen, Germany, 45122
Sponsors and Collaborators
University Hospital, Essen
OnkoDataMed GmbH
Investigators
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Principal Investigator: Dirk Schadendorf, Professor Universitätsklinikum Essen

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Responsible Party: Prof. Dr. med. Dirk Schadendorf, Prof. Dr. med., University Hospital, Essen
ClinicalTrials.gov Identifier: NCT02781389     History of Changes
Other Study ID Numbers: ML29828
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Dr. med. Dirk Schadendorf, University Hospital, Essen:
Basal cell carcinoma (BCC)
advanced BCC (aBCC)

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