A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)

Basal Cell Carcinoma Clinical Trial

— ROSETT  

Official title:

A Prospective Observational Study of Erivedge® Treatment, Effectiveness, and Safety Outcomes in Patients With Advanced Basal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371967
• Other study ID #: ML29507
• Status: Completed
• Start date: April 8, 2015
• Est. completion date: August 19, 2020

Study information

• Verified date: October 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective, observational, cohort study is designed to assess the effectiveness and safety outcomes of vismodegib and to assess actual day-to-day disease and participant management by the physician.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BCC that meets one of the study's pre-specified cohort definitions

• Physician's decision to treat participant with vismodegib as per local label

• Participant who has not participated in a clinical trial within 90 days prior to study enrollment, with the exception of participants who meet the criteria for Cohort 2 (No Gorlin Syndrome Participants With Prior HPI Exposure)

Exclusion Criteria:

• Female participants are excluded if they are pregnant or if they plan to become pregnant during treatment or within 2 years after end of treatment

• Male participants with female partners of childbearing potential are excluded if they plan to impregnate their partner during treatment or within 2 months after end of treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Drug:
• Vismodegib
Vismodegib therapy will be given in compliance with the physician's standard practice as per local label.

Locations

Country	Name	City	State
Sweden	SU/Sahlgrenska, Hudkliniken	Göteborg
Sweden	Skånes Universitetssjukhus; Hudkliniken	Lund
Sweden	Radiumhemmet	Solna
Sweden	Norrlands universitetssjukhus; Onkologkliniken	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Clinical Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)		From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
Primary	Time to Clinical Response as Assessed by Investigator According to RECIST v1.1		From the date of first treatment until the date of first documented confirmed complete response (CR) or partial response (PR) (whichever occurs first) (up to approximately 3 years)
Primary	Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1		From the date of occurrence of first clinical response up to the date of progression or death from any cause (up to approximately 3 years)
Primary	Percentage of Participants who Experience a Recurrence		From Baseline up to end of study (up to approximately 3 years)
Primary	Progression-Free Survival (PFS) as Assessed by Investigator According to RECIST v1.1		From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
Primary	Overall survival (OS)		From the date of first treatment until death due to any cause (up to approximately 3 years)
Primary	Percentage of Participants With Adverse Events		From Baseline up to end of study (up to approximately 3 years)
Primary	Duration of Vismodegib Treatment		Baseline up to approximately 3 years
Primary	Percentage of Participants With Vismodegib Treatment Interruption		Baseline up to approximately 3 years