Locally Advanced Basal Cell CarcinomaPhase 2SONIBECNCT04806646
Tailored Sonidegib Schedule After Complete Response in BCC
A Phase 2 study testing Sonidegib in people with Locally Advanced Basal Cell Carcinoma, run by Gruppo Oncologico del Nord-Ovest at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Basal Cell Carcinoma
- What is being tested?
- Sonidegib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2021to 22 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written, signed informed consent, including consent to photographs of lesions.
- Age ≥ 18 years.
- Histologic confirmation of locally advanced BCC lesion.
- 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
Show all 23Show fewer
- 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
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hematopoietic capacity, defined as the following:
- Haemoglobin > 8.5 g/dl
- Absolute neutrophil count (ANC) ≥ 1000/mmc
- Platelet count ≥ 75,000/mmc
- 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
- For women of childbearing potential, a negative pregnancy test within 7 days prior to commencement of dosing is required
- 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.
- Participant must agree to not breastfeed during the study and for 20 months after the last dose of study treatment.
- 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.
- Agreement not to donate blood or blood products during the study and for at least 20 months after the last dose was received.
- For male patients, agreement not to donate sperm during treatment and for 6 months after the last dose was received.
Who cannot join
- Metastatic BCC.
- Inability or unwillingness to swallow capsules.
- Inability or unwillingness to comply with study procedures.
- Pregnancy or lactation.
- 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).
- Uncontrolled medical illness, including advanced malignancies, at the discretion of the Investigator.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Locally Advanced Basal Cell Carcinoma
- Being tested
- Sonidegib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonidegibDrug
Also called Odomzo
TS1: assumption 14 days on and 14 days off. TS2: assumption 7 days on and 21 days off.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Treatment | Experimental | 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. Receives: Drug: Sonidegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintaining tailored treatment
Proportion of patients maintaining the tailored treatment with sonidegib 12 months after enrolment into the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start12 Jan 2021
- Primary completion22 Dec 2024
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico del Nord-Ovest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Bossi, MD, Principal investigator, Gono - ASST Spedali Civili Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806646
- Sponsor's protocol ID
- SONIBEC
- Acronym
- SONIBEC
- Status last verified
- May 2026
- First submitted
- 17 Mar 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04806646
- Acronym / sponsor ID
- SONIBEC / SONIBEC
- Conditions
- Locally Advanced Basal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Gruppo Oncologico del Nord-OvestUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 22 Dec 2026 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Treatment | Experimental | Drug: SonidegibOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Written, signed informed consent, including consent to photographs of lesions.
- Age ≥ 18 years.
- Histologic confirmation of locally advanced BCC lesion.
- Patients with BCCs already in treatment with Hedgehog inhibitor sonidegib for:
- 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.
Key exclusion criteria (7 listed)
- Metastatic BCC.
- Inability or unwillingness to swallow capsules.
- Inability or unwillingness to comply with study procedures.
- Pregnancy or lactation.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonidegibAlso: OdomzoTS1: assumption 14 days on and 14 days off. TS2: assumption 7 days on and 21 days off. | Drug | Single Arm Treatment |
Primary outcome
Maintaining tailored treatment
Time frame: 12 months
Proportion of patients maintaining the tailored treatment with sonidegib 12 months after enrolment into the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bossi, MD principal investigator
Gono - ASST Spedali Civili Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sonidegib in people with Locally Advanced Basal Cell Carcinoma, run by Gruppo Oncologico del Nord-Ovest at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintaining tailored treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.