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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
EU CTIS ID: 2024-516797-29-00
What this study is testing
To evaluate the compliance to a tailored regimen of sonidegib in patients who have previously obtained CR assuming any inhibitor of the Hedgehog pathway.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written, signed informed consent, including consent to photographs of lesions.
- Per donne in età fertile, test di gravidanza negativo entro 7 giorni dall’inizio della terapia.
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- Written, signed informed consent, including consent to photographs of lesions.
- Per donne in età fertile, test di gravidanza negativo entro 7 giorni dall’inizio della terapia.
- 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.
- Age ≥ 18 years.
- Histologic confirmation of locally advanced BCC lesion.
- Patients with BCCs already in treatment with Hedgehog inhibitor 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
- Patient having shown a complete response (CR) to Hedgehog inhibitor 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
What rules you out
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.