Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04552990 - Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma Phase 2
Completed NCT04229277 - Fast Track Diagnosis of Skin Cancer by Advanced Imaging N/A
Completed NCT05608902 - Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study (DOCTOBA)
Completed NCT05077033 - Intratumoral phIL12 GET Phase 1
Active, not recruiting NCT04928222 - Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II) Phase 1/Phase 2
Recruiting NCT04929535 - Hydrogen Peroxide Trial to Investigate the Efficacy of 30%H2O2 as a Topical Application Before Definitive Treatment Phase 2
Completed NCT02662244 - Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma N/A
Completed NCT00959647 - A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study Phase 2
Completed NCT00586040 - Photochemical Tissue Bonding Phase 2
Completed NCT00793169 - Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Completed NCT00473343 - Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma Phase 3
Active, not recruiting NCT06024629 - cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
Not yet recruiting NCT05324202 - New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management N/A
Withdrawn NCT04099446 - A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer
Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A
Completed NCT01260987 - Fractional CO2 Laser Assisted Photodynamic Therapy Phase 2/Phase 3
Completed NCT01208831 - An East Asian Study of LDE225 Phase 1
Completed NCT01201915 - A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma Phase 2
Completed NCT01014819 - A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions N/A
Completed NCT00472043 - PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma Phase 3