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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02371967
Other study ID # ML29507
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 8, 2015
Est. completion date August 19, 2020

Study information

Verified date October 2020
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 19, 2020
Est. primary completion date August 19, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden SU/Sahlgrenska, Hudkliniken Göteborg
Sweden Skånes Universitetssjukhus; Hudkliniken Lund
Sweden Radiumhemmet Solna
Sweden Norrlands universitetssjukhus; Onkologkliniken Umeå

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary Percentage of Participants who Experience a Recurrence From Baseline up to end of study (up to approximately 3 years)
Primary 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)
Primary Overall survival (OS) From the date of first treatment until death due to any cause (up to approximately 3 years)
Primary Percentage of Participants With Adverse Events From Baseline up to end of study (up to approximately 3 years)
Primary Duration of Vismodegib Treatment Baseline up to approximately 3 years
Primary Percentage of Participants With Vismodegib Treatment Interruption Baseline up to approximately 3 years
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