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

NCT02371967 | Completed

• 1 other identifier: ML29507
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (9)

• Percentage of Participants With Clinical Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)

  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

  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

  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

  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

  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)

  From the date of first treatment until death due to any cause (up to approximately 3 years)

• Percentage of Participants With Adverse Events

  From Baseline up to end of study (up to approximately 3 years)

• Duration of Vismodegib Treatment

  Baseline up to approximately 3 years

• Percentage of Participants With Vismodegib Treatment Interruption

  Baseline up to approximately 3 years

Study Arms (3)

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

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

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

Interventions

Vismodegib DRUG

Vismodegib therapy will be given in compliance with the physician's standard practice as per local label.

Also known as: Erivedge®

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

SU/Sahlgrenska, Hudkliniken

Gothenburg, 41345, Sweden

Location

Skånes Universitetssjukhus; Hudkliniken

Lund, 222 41, Sweden

Location

Radiumhemmet

Solna, 171 64, Sweden

Location

Norrlands universitetssjukhus; Onkologkliniken

Umeå, Sweden

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

HhAntag691

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: February 26, 2015
• Study Start: April 8, 2015
• Primary Completion: August 19, 2020
• Study Completion: August 19, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

SE (4)