Clinical trial NCT02371967: A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)
Official title: A Prospective Observational Study of Erivedge® Treatment, Effectiveness, and Safety Outcomes in Patients With Advanced Basal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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

Primary outcomes:
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)
timeFrame: From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
measure: Time to Clinical Response as Assessed by Investigator According to RECIST v1.1
timeFrame: 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)
measure: Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1
timeFrame: 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)
measure: Percentage of Participants who Experience a Recurrence
timeFrame: From Baseline up to end of study (up to approximately 3 years)
measure: Progression-Free Survival (PFS) as Assessed by Investigator According to RECIST v1.1
timeFrame: From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)
measure: Overall survival (OS)
timeFrame: From the date of first treatment until death due to any cause (up to approximately 3 years)
measure: Percentage of Participants With Adverse Events
timeFrame: From Baseline up to end of study (up to approximately 3 years)
measure: Duration of Vismodegib Treatment
timeFrame: Baseline up to approximately 3 years
measure: Percentage of Participants With Vismodegib Treatment Interruption
timeFrame: Baseline up to approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: SU/Sahlgrenska, Hudkliniken
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus; Hudkliniken
city: Solna
country: Sweden
facility: Radiumhemmet
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus; Onkologkliniken
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: