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Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study

NCT05463757 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-04-04

No results posted yet for this study

Summary

Background: Oral hedgehog inhibitors vismodegib and sonidegib have been used for the treatment of locally advanced (laBCC), metastatic basal cell carcinoma (mBCC) and in basal cell nevus syndrome (BCNS) patients. In the Netherlands, targeted therapy with vismodegib and sonidegib has been available since 2013 and 2021, respectively. No direct comparative studies have been performed between the two oral hedgehog inhibitors (HHI) vismodegib and sonidegib yet . In addition, data for sonidegib are not yet available.

Objective: The aim of this study is 1) to evaluate the effectiveness of oral HHIs in the treatment of laBCC, mBCC and BCNS patients and 2) to compare the oral HHIs vismodegib and sonidegib.

Study design: prospective registration study that includes all patients, regardless of age and gender, with histologically proven basal cell carcinoma receiving treatment with either vismodegib or sonidegib in the Netherlands. Patient, tumor and treatment information was gathered from patient records.

Main study parameters/endpoints: The primary outcome for measuring efficacy/tumor response was median progression free survival (PFS) where the decrease, stagnation or increase in tumor size is measured by maximum diameter. Secondary outcomes are frequency, severity and reversibility of treatment-emergent adverse events and disease-specific quality of life expressed as mean scores on the EORTC-QLQ-C30 and aBCCdex questionnaires.

Conditions

  • Basal Cell Carcinoma
  • Locally Advanced Basal Cell Carcinoma
  • Metastatic Basal Cell Carcinoma
  • Gorlin Syndrome
  • Basal Cell Nevus Syndrome
  • Carcinoma, Basal Cell
  • Carcinoma
  • Basal Cell Tumor
  • Skin Cancer
  • Neoplasm of Skin
  • Neoplasms, Basal Cell

Interventions

DRUG

Vismodegib

Oral vismodegib (Erivedge), taken daily or every other day (depending on doctor's description)

DRUG

Sonidegib

Sonidegib (Odomzo), taken daily or every other day (depending on doctor's description)

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • K Mosterd, MD, PhD · Maastricht University Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05463757 on ClinicalTrials.gov