Basal Cell CarcinomaROSETTNCT02371967
A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)
An observational study of Basal Cell Carcinoma, run by Hoffmann-La Roche at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Vismodegib
- How many people
- 50 participants
- Where
- 4 sitesSweden
- Study dates
- 8 Apr 2015to 19 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
SU/Sahlgrenska, Hudkliniken
Gothenburg, 41345
Skånes Universitetssjukhus; Hudkliniken
Lund, 222 41
Radiumhemmet
Solna, 171 64
Norrlands universitetssjukhus; Onkologkliniken
Umeå
About this study
Official title: 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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Vismodegib
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VismodegibDrug
Also called Erivedge®
Vismodegib therapy will be given in compliance with the physician's standard practice as per local label.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vismodegib | |
| 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. Receives: Drug: Vismodegib | |
| 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. Receives: Drug: Vismodegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Clinical Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: From the date of first treatment until death due to any cause (up to approximately 3 years)
Percentage of Participants With Adverse Events
Measured: From Baseline up to end of study (up to approximately 3 years)
Duration of Vismodegib Treatment
Measured: Baseline up to approximately 3 years
Percentage of Participants With Vismodegib Treatment Interruption
Measured: Baseline up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study start8 Apr 2015
- Primary completion19 Aug 2020
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371967
- Sponsor's protocol ID
- ML29507
- Acronym
- ROSETT
- Status last verified
- Oct 2020
- First submitted
- 20 Feb 2015
- Last updated
- 9 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Erivedge® Treatment, Effectiveness, and Safety Outcomes in Patients With Advanced Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02371967
- Acronym / sponsor ID
- ROSETT / ML29507
- Conditions
- Basal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Gorlin Syndrome Participants With No Prior HPI Exposure | – | Drug: VismodegibBCC 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 | – | Drug: VismodegibBCC 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 | – | Drug: VismodegibBCC 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VismodegibAlso: Erivedge®Vismodegib therapy will be given in compliance with the physician's standard practice as per local label. | Drug | Gorlin Syndrome Participants With/Without Prior HPI Exposure, No Gorlin Syndrome Participants With No Prior HPI Exposure, No Gorlin Syndrome Participants With Prior HPI Exposure |
Primary outcome
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)
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)
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)
Percentage of Participants who Experience a Recurrence
Time frame: 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)
Overall survival (OS)
Time frame: 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)
Duration of Vismodegib Treatment
Time frame: Baseline up to approximately 3 years
Percentage of Participants With Vismodegib Treatment Interruption
Time frame: Baseline up to approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
Related trials for Basal Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Basal Cell Carcinoma (BCC), First Line Treatment
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Hoffmann-La Roche at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.