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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)
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Scientific title
A Prospective Observational Study of Erivedge® Treatment, Effectiveness, and Safety Outcomes in Patients With Advanced Basal Cell Carcinoma
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Secondary ID [1]
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ML29507
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Universal Trial Number (UTN)
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Trial acronym
ROSETT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Clinical Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
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Assessment method [1]
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Timepoint [1]
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From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
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Primary outcome [2]
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Time to Clinical Response as Assessed by Investigator According to RECIST v1.1
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Assessment method [2]
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Timepoint [2]
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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)
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Primary outcome [3]
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Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1
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Assessment method [3]
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Timepoint [3]
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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)
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Primary outcome [4]
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Percentage of Participants who Experience a Recurrence
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Assessment method [4]
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Timepoint [4]
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From Baseline up to end of study (up to approximately 3 years)
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Primary outcome [5]
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Progression-Free Survival (PFS) as Assessed by Investigator According to RECIST v1.1
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Assessment method [5]
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Timepoint [5]
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From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
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Primary outcome [6]
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Overall survival (OS)
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Assessment method [6]
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Timepoint [6]
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From the date of first treatment until death due to any cause (up to approximately 3 years)
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Primary outcome [7]
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Percentage of Participants With Adverse Events
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Assessment method [7]
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Timepoint [7]
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From Baseline up to end of study (up to approximately 3 years)
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Primary outcome [8]
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Duration of Vismodegib Treatment
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Assessment method [8]
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Timepoint [8]
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Baseline up to approximately 3 years
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Primary outcome [9]
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Percentage of Participants With Vismodegib Treatment Interruption
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Assessment method [9]
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Timepoint [9]
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Baseline up to approximately 3 years
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/04/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/08/2020
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Sweden
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State/province [1]
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Göteborg
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Country [2]
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Sweden
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State/province [2]
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Lund
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Country [3]
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Sweden
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State/province [3]
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Solna
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Country [4]
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Sweden
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State/province [4]
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Umeå
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02371967
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Trial related presentations / publications
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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
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02371967
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