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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02371967




Registration number
NCT02371967
Ethics application status
Date submitted
20/02/2015
Date registered
26/02/2015
Date last updated
9/10/2020

Titles & IDs
Public title
A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)
Scientific title
A Prospective Observational Study of Erivedge® Treatment, Effectiveness, and Safety Outcomes in Patients With Advanced Basal Cell Carcinoma
Secondary ID [1] 0 0
ML29507
Universal Trial Number (UTN)
Trial acronym
ROSETT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Vismodegib

No Gorlin Syndrome Participants With No Prior HPI Exposure - BCC participants with advanced disease and no Gorlin syndrome, and who have not been exposed previously to an Hedgehog Pathway Inhibitor (HPI) (e.g., Vismodegib, LDE225) prior to diagnosis of advanced disease; will receive vismodegib therapy in compliance with the physician's standard practice as per local label and will be followed-up for approximately 3 years or until death, withdrawal of consent, sponsor's decision, lost to follow-up or end of study.

No Gorlin Syndrome Participants With Prior HPI Exposure - BCC participants with advanced disease and no Gorlin syndrome, and who have been exposed previously to an HPI (e.g., during clinical studies with vismodegib [SHH4476g {NCT00833417}, MO25616 {NCT01367665}] or LDE225); will receive vismodegib therapy in compliance with the physician's standard practice as per local label and will be followed-up for approximately 3 years or until death, withdrawal of consent, sponsor's decision, lost to follow-up or end of study.

Gorlin Syndrome Participants With/Without Prior HPI Exposure - BCC participants with advanced disease and Gorlin syndrome, and who have or have not been previously exposed to an HPI (e.g., during clinical studies); will receive vismodegib therapy in compliance with the physician's standard practice as per local label and will be followed-up for approximately 3 years or until death, withdrawal of consent, sponsor's decision, lost to follow-up or end of study.


Treatment: Drugs: Vismodegib
Vismodegib therapy will be given in compliance with the physician's standard practice as per local label.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Clinical Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Timepoint [1] 0 0
From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
Primary outcome [2] 0 0
Time to Clinical Response as Assessed by Investigator According to RECIST v1.1
Timepoint [2] 0 0
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 outcome [3] 0 0
Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1
Timepoint [3] 0 0
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 outcome [4] 0 0
Percentage of Participants who Experience a Recurrence
Timepoint [4] 0 0
From Baseline up to end of study (up to approximately 3 years)
Primary outcome [5] 0 0
Progression-Free Survival (PFS) as Assessed by Investigator According to RECIST v1.1
Timepoint [5] 0 0
From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
Primary outcome [6] 0 0
Overall survival (OS)
Timepoint [6] 0 0
From the date of first treatment until death due to any cause (up to approximately 3 years)
Primary outcome [7] 0 0
Percentage of Participants With Adverse Events
Timepoint [7] 0 0
From Baseline up to end of study (up to approximately 3 years)
Primary outcome [8] 0 0
Duration of Vismodegib Treatment
Timepoint [8] 0 0
Baseline up to approximately 3 years
Primary outcome [9] 0 0
Percentage of Participants With Vismodegib Treatment Interruption
Timepoint [9] 0 0
Baseline up to approximately 3 years

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2020
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Sweden
State/province [1] 0 0
Göteborg
Country [2] 0 0
Sweden
State/province [2] 0 0
Lund
Country [3] 0 0
Sweden
State/province [3] 0 0
Solna
Country [4] 0 0
Sweden
State/province [4] 0 0
Umeå

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02371967
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries