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

October 8, 2020 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 41345
        • SU/Sahlgrenska, Hudkliniken
      • Lund, Sweden, 222 41
        • Skånes Universitetssjukhus; Hudkliniken
      • Solna, Sweden, 171 64
        • Radiumhemmet
      • Umeå, Sweden
        • Norrlands universitetssjukhus; Onkologkliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include adult participants with advanced BCC, in whom the treating physician has made the decision to commence vismodegib treatment (in accordance with the local label).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Vismodegib
Vismodegib therapy will be given in compliance with the physician's standard practice as per local label.
Other Names:
  • Erivedge®
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.
Drug: Vismodegib
Vismodegib therapy will be given in compliance with the physician's standard practice as per local label.
Other Names:
  • Erivedge®
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.
Drug: Vismodegib
Vismodegib therapy will be given in compliance with the physician's standard practice as per local label.
Other Names:
  • Erivedge®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Clinical Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Time Frame: From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
Time to Clinical Response as Assessed by Investigator According to RECIST v1.1
Time Frame: 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)
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)
Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1
Time Frame: 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)
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)
Percentage of Participants who Experience a Recurrence
Time Frame: From Baseline up to end of study (up to approximately 3 years)
From Baseline up to end of study (up to approximately 3 years)
Progression-Free Survival (PFS) as Assessed by Investigator According to RECIST v1.1
Time Frame: From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
Overall survival (OS)
Time Frame: From the date of first treatment until death due to any cause (up to approximately 3 years)
From the date of first treatment until death due to any cause (up to approximately 3 years)
Percentage of Participants With Adverse Events
Time Frame: From Baseline up to end of study (up to approximately 3 years)
From Baseline up to end of study (up to approximately 3 years)
Duration of Vismodegib Treatment
Time Frame: Baseline up to approximately 3 years
Baseline up to approximately 3 years
Percentage of Participants With Vismodegib Treatment Interruption
Time Frame: Baseline up to approximately 3 years
Baseline up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2015

Primary Completion (Actual)

August 19, 2020

Study Completion (Actual)

August 19, 2020

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29507

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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