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

Roche

Status: Completed

Conditions: Basal Cell Carcinoma

Treatments: Drug: Vismodegib

Study type: Observational

Funder types: Industry

Identifiers

NCT02371967

ML29507

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 3 patient groups

No Gorlin Syndrome Participants With No Prior HPI Exposure

Description:

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.

Treatment:

Drug: Vismodegib

No Gorlin Syndrome Participants With Prior HPI Exposure

Description:

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.

Treatment:

Drug: Vismodegib

Gorlin Syndrome Participants With/Without Prior HPI Exposure

Description:

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:

Drug: Vismodegib