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

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ClinicalTrials.gov Identifier: NCT02371967
Recruitment Status : Active, not recruiting
First Posted : February 26, 2015
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment
Basal Cell Carcinoma Drug: Vismodegib

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Erivedge® Treatment, Effectiveness, and Safety Outcomes in Patients With Advanced Basal Cell Carcinoma
Actual Study Start Date : April 8, 2015
Estimated Primary Completion Date : August 29, 2020
Estimated Study Completion Date : August 29, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

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 Name: 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 Name: 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 Name: Erivedge®




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. Percentage of Participants who Experience a Recurrence [ Time Frame: From Baseline up to end of study (up to approximately 3 years) ]
  5. 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) ]
  6. Overall survival (OS) [ Time Frame: From the date of first treatment until death due to any cause (up to approximately 3 years) ]
  7. Percentage of Participants With Adverse Events [ Time Frame: From Baseline up to end of study (up to approximately 3 years) ]
  8. Duration of Vismodegib Treatment [ Time Frame: Baseline up to approximately 3 years ]
  9. Percentage of Participants With Vismodegib Treatment Interruption [ Time Frame: Baseline up to approximately 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371967


Locations
Sweden
SU/Sahlgrenska, Hudkliniken
Göteborg, Sweden, 41345
Skånes Universitetssjukhus; Hudkliniken
Lund, Sweden, 222 41
Radiumhemmet
Solna, Sweden, 171 64
Norrlands universitetssjukhus; Onkologkliniken
Umeå, Sweden
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02371967     History of Changes
Other Study ID Numbers: ML29507
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell