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Completed

NCT Number: NCT02371967

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SU/Sahlgrenska, Hudkliniken, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vismodegib

Drug

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

Other names: Erivedge®

Primary outcomes

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

    Time frame: From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)

  2. Time to Clinical Response as Assessed by Investigator According to RECIST v1.1

    Time frame: 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)

  3. Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1

    Time frame: 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)

  4. Percentage of Participants who Experience a Recurrence

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

  5. Progression-Free Survival (PFS) as Assessed by Investigator According to RECIST v1.1

    Time frame: From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years)

  6. Overall survival (OS)

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

  7. Percentage of Participants With Adverse Events

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

  8. Duration of Vismodegib Treatment

    Time frame: Baseline up to approximately 3 years

  9. Percentage of Participants With Vismodegib Treatment Interruption

    Time frame: Baseline up to approximately 3 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Prospective Observational Study of Erivedge® Treatment, Effectiveness, and Safety Outcomes in Patients With Advanced Basal Cell Carcinoma

Acronym: ROSETT

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2015
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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