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Dose-Modulated Sonidegib Therapy for Periocular Basal Cell Carcinoma

NCT07068568 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2025-07-16

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, and clinical outcomes of a dose-modulation strategy of Sonidegib in adult patients with locally advanced periocular basal cell carcinoma (laBCC) who are not candidates for surgery or radiotherapy. The main questions it aims to answer are:

* Can dose-adjusted Sonidegib treatment preserve ocular function and avoid disfiguring surgery in laBCC patients?
* What is the rate of tumor response, recurrence, and adverse events during dose-modulated treatment?

Researchers will compare different dosing regimens based on treatment response, tolerability, and toxicity profiles to assess whether intermittent dosing or dose reductions can maintain clinical benefits while minimizing adverse effects.

This monocentric retrospective observational real-world evidence (RWE) study included 12 patients (8 male, 4 female; aged between 67 and 92 years; mean 83.25 years) with histologically confirmed periocular laBCC (staged T3-T4b) treated with sonidegib between 2021-2023 at the Oculoplasty Unit of the University of Naples Federico II. Eligible patients were those for whom conventional surgery or radiotherapy would result in loss of vision or unacceptable cosmetic outcomes.

Participants:

* Took Sonidegib orally, starting at 200 mg daily, with possible dose interruptions or reductions based on individual tolerance and tumor response.
* Underwent clinical and ophthalmologic evaluations every 4-6 weeks.
* Had imaging and dermatologic assessments to monitor tumor regression.
* Completed follow-up visits after treatment completion to assess long-term control and safety.

The results of this study aim to support an eye-sparing, patient-centered approach for complex periocular tumors.

Conditions

  • Basal Cell Cancer
  • Eyelid Tumor
  • Basal Cell Carcinoma (BCC)
  • Basal Cell Carcinoma of the Head and Neck

Interventions

DRUG

Sonidegib

Sonidegib was administered orally at a dose of 200 mg once daily as per approved guidelines. The intervention was applied in a real-world clinical setting to patients with histologically confirmed, locally advanced periocular basal cell carcinoma (laBCC) deemed unsuitable for surgical resection or radiotherapy due to the tumor's extent or proximity to critical ocular structures. A flexible, individualized dose modulation strategy was implemented to manage adverse effects and optimize patient adherence. Modifications included temporary treatment interruptions or reduced dosing frequency, tailored to each patient's clinical status and tolerance. The goal of the intervention was to achieve local tumor control while preserving ocular structures, visual function, and cosmetic appearance. All patients received regular multidisciplinary follow-up, including ophthalmologic and dermatologic assessments.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Diego Strianese, MD, PhD · Federico II University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2023-12-20
Completion
2024-03-20
FDA Drug
Yes

Countries

  • Italy

Study Locations

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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 NCT07068568 on ClinicalTrials.gov