Basal Cell Carcinoma Clinical Trial
— ROSETTOfficial title:
A Prospective Observational Study of Erivedge® Treatment, Effectiveness, and Safety Outcomes in Patients With Advanced Basal Cell Carcinoma
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 |
Verified date | October 2020 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | SU/Sahlgrenska, Hudkliniken | Göteborg | |
Sweden | Skånes Universitetssjukhus; Hudkliniken | Lund | |
Sweden | Radiumhemmet | Solna | |
Sweden | Norrlands universitetssjukhus; Onkologkliniken | Umeå |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Sweden,
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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