Carcinoma, Basal CellNIELSNCT02674009
Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)
An observational study of Carcinoma, Basal Cell, run by Hoffmann-La Roche at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- Vismodegib
- How many people
- 67 participants
- Where
- 1 siteGermany
- Study dates
- 17 Sep 2015to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
Frankfurt, 60590
About this study
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)
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
- Being tested
- Vismodegib
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VismodegibDrug
Also called ERIVEDGE
Participants with laBCC will receive a dosing of Vismodegib in accordance with local clinical practice and local labeling.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Vismodegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: From the date of first therapy to disease progression or death from any cause, up to 3 years
Overall Survival
Measured: From the date of the first therapy to death from any cause, up to 3 years
Time to Response
Measured: 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
Measured: From Baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start17 Sep 2015
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674009
- Sponsor's protocol ID
- ML29670
- Acronym
- NIELS
- Status last verified
- May 2019
- First submitted
- 2 Feb 2016
- Last updated
- 13 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02674009
- Acronym / sponsor ID
- NIELS / ML29670
- Conditions
- Carcinoma, Basal Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laBCC Participants | – | Drug: VismodegibParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VismodegibAlso: ERIVEDGEParticipants with laBCC will receive a dosing of Vismodegib in accordance with local clinical practice and local labeling. | Drug | laBCC Participants |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Basal Cell, run by Hoffmann-La Roche at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.