Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions

Basal Cell Carcinoma Clinical Trial

— JONAS  

Official title:

Non-interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781389
• Other study ID #: ML29828
• Status: Completed
• Start date: April 29, 2016
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2021
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie (Universitätsklinikum Essen)	Essen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Essen	OnkoDataMed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explorative outcome measures: tumor response	- type of tumor response as determined by the treating physician by clinical assessment and/or histological assessment and/or imaging assessment	up to 3 years from first dose Vismodegib
Other	Explorative outcome measures: treatment decision for therapy with Vismodegib	- treatment decision for therapy with Vismodegib by tumor board OR by otorhinolaryngologist, surgeon, plastic surgeon, dermato-oncologist, radiotherapist, ophthalmologist	up to 3 years from first dose Vismodegib
Other	Explorative outcome measures: previous treatment	- previous treatment for the BCC lesion, which led to therapy with Vismodegib	up to 3 years from first dose Vismodegib
Other	Explorative outcome measures: therapy after Vismodegib	- BCC therapy after Vismodegib therapy	up to 3 years from first dose Vismodegib
Other	Explorative outcome measures: duration of therapy with Vismodegib	- time of treatment with Vismodegib	up to 3 years from first dose Vismodegib
Other	Explorative outcome measures: Vismodegib therapy interruptions	- time to treatment interruptions of Vismodegib	up to 3 years from first dose Vismodegib
Other	Explorative outcome measures: Vismodegib treatment discontinuation	- reason for treatment discontinuation of Vismodegib	up to 3 years from first dose Vismodegib
Primary	Primary effectiveness measure: duration of response (partial or complete) until progression, death or up to 3 years from first dose Vismodegib (whichever occurs first)	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.	up to 3 years from first dose Vismodegib
Secondary	Secondary effectiveness measure: - objective response rate	number of patients with complete response or partial response as determined by the treating physician by clinical assessment, histological assessment, imaging assessment	up to 3 years from first dose Vismodegib
Secondary	Secondary effectiveness measure: - time to response	time from first dose Vismodegib to complete response or partial response up to 3 years	up to 3 years from first dose Vismodegib
Secondary	Secondary effectiveness measure: - disease control rate	number of complete response, partial response, stable disease	up to 3 years from first dose Vismodegib
Secondary	Secondary effectiveness measure: - recurrence rate	number of patients who responded (partial or complete) and later progressed	up to 3 years from first dose Vismodegib
Secondary	Secondary effectiveness measure: - time to progression	time from first dose Vismodegib to progression up to 3 years	up to 3 years from first dose Vismodegib
Secondary	Secondary effectiveness measure: - survival	time from first dose Vismodegib to death of any cause	up to 3 years from first dose Vismodegib