Tailored Sonidegib Schedule After Complete Response in BCC (SONIBEC)

A Phase II, Open-label Study Improving Compliance and Time of Treatment After Obtaining Complete Response Through a Tailored Schedule of Sonidegib in Locally Advanced Basal Cell Carcinomas (BCC) - the SONIBEC Trial

Adult patients with locally advanced BCC, not amenable to surgical treatment and who obtained a complete response (CR) to Hedgehog inhibitors are administered a tailored schedule of the study drug. The tailored schedule consists of a change in the time of drug assumption. It implements some weeks of assumption and some weeks of suspension of sonidegib rather than a continuous administration.

Study Overview

• Status: Active, not recruiting
• Conditions: Locally Advanced Basal Cell Carcinoma
• Intervention / Treatment: Drug: Sonidegib

Detailed Description

One cycle of therapy is defined as 28 days of sonidegib. The patient will start with first schedule.

• Treatment schedule 1 (TS1): assumption 14 days on and 14 days off. TS1 may be temporary interrupted for any grade 2 or 3 toxicity (excluding alopecia) until return to grade 1. If the patient experiences any grade 3 or 2 side effects lasting for more than 28 days, at treatment resumption they will start the TS2 schedule.
• Treatment schedule 2 (TS2): assumption 7 days on and 21 days off. TS2 may be temporary interrupted for any grade 2 or 3 toxicity (excluding alopecia) until return to grade 1. If the patient experiences any grade 3 or 2 side effects lasting for more than 28 days, he/she is discontinued from the study.

If progression of disease is observed (during TS1 or TS2) the patient is discontinued from the study.

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy
    • Asst Degli Spedali Civili Di Brescia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written, signed informed consent, including consent to photographs of lesions.
2. Age ≥ 18 years.
3. Histologic confirmation of locally advanced BCC lesion.

4. Patients with BCCs already in treatment with Hedgehog inhibitor sonidegib for:

   • BCC that has recurred in the same location after three or more surgical procedures and/or curative resection is deemed unlikely
   • multifocal BCC or extensive tumours with bleeding or infected areas
   • anticipated substantial morbidity and/or deformity from surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation)
   • multiple BCCs not amenable to surgical treatment because of oncologic or clinical reasons
5. Patient having shown a complete response (CR) to Hedgehog inhibitor sonidegib within the 3 months prior to the screening. In BCC every effort should be made to obtain histologic confirmation of CR mainly in case of doubt, performing several biopsies in the sites where disease was present. CR must have been confirmed by 2 consecutive radiologic exams and by visual and dermoscopic examinations.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

7. Adequate hematopoietic capacity, defined as the following:

   • Haemoglobin > 8.5 g/dl
   • Absolute neutrophil count (ANC) ≥ 1000/mmc
   • Platelet count ≥ 75,000/mmc

8. Adequate hepatic and renal function, defined as the following:

   • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), Total bilirubin ≤ 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome
   • Calculated serum creatinine clearance (CrCl) ≥ 30 mL/min
9. For women of childbearing potential, a negative pregnancy test within 7 days prior to commencement of dosing is required
10. Women of child-bearing potential must use two methods of acceptable contraception including one highly effective method and a barrier method, as directed by their physician, during treatment and for at least 20 months after completion of study treatment. Highly effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception, or intra-uterine devices). Check Appendix B for details.
11. Participant must agree to not breastfeed during the study and for 20 months after the last dose of study treatment.
12. For male patients with female partners of childbearing potential, agreement to use a condom, even after a vasectomy, during sexual intercourse with female partners while being treated with sonidegib, and for 6 months after the last dose was received.
13. Agreement not to donate blood or blood products during the study and for at least 20 months after the last dose was received.
14. For male patients, agreement not to donate sperm during treatment and for 6 months after the last dose was received.

Exclusion Criteria:

1. Metastatic BCC.
2. Inability or unwillingness to swallow capsules.
3. Inability or unwillingness to comply with study procedures.
4. Pregnancy or lactation.
5. Concurrent non-protocol-specified anti-tumour therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy, including participation in an experimental drug study).
6. Uncontrolled medical illness, including advanced malignancies, at the discretion of the Investigator.
7. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm Treatment; One cycle of therapy is defined as 28 days of sonidegib. The patient will start with TS1 schedule.; TS1: assumption 14 days on and 14 days off. TS1 may be temporary interrupted for any grade 2 or 3 toxicity (excluding alopecia) until return to grade 1. If the patient experiences any grade 3 or 2 side effects lasting for more than 28 days, at treatment resumption they will start the TS2 schedule.; TS2: assumption 7 days on and 21 days off. TS2 may be temporary interrupted for any grade 2 or 3 toxicity (excluding alopecia) until return to grade 1. If the patient experiences any grade 3 or 2 side effects lasting for more than 28 days, he/she is discontinued from the study. If progression of disease is observed (during TS1 or TS2) the patient is discontinued from the study.

Drug: Sonidegib; TS1: assumption 14 days on and 14 days off. TS2: assumption 7 days on and 21 days off.; Other Names: Odomzo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintaining tailored treatment	Proportion of patients maintaining the tailored treatment with sonidegib 12 months after enrolment into the study.	12 months

Collaborators and Investigators

• Sponsor: Gruppo Oncologico del Nord-Ovest
• Investigators: Principal Investigator: Paolo Bossi, MD, Gono - ASST Spedali Civili Brescia

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Actual): December 22, 2024
• Study Completion (Estimated): December 22, 2026

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell; sonidegib
• Other Study ID Numbers: SONIBEC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No