Sonidegib in Adult Patients With Locally Advanced Basal Cell Carcinoma (laBCC) in China (NCT06880848) | Clinical Trial Compass
CompletedPhase 4
Sonidegib in Adult Patients With Locally Advanced Basal Cell Carcinoma (laBCC) in China
China160 participantsStarted 2023-06-21
Plain-language summary
This is a Phase IV, single arm, multicenter study designed to evaluate the efficacy and safety profile of Sonidegib in chinese participants with locally advanced basal cell carcinoma (laBCC) who are not amenable to radiation therapy, curative surgery or other local therapies.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 years or older.
. Patients with a histologically confirmed diagnosis of laBCC that is not amenable to radiation therapy, curative surgery, or other local therapies. Patients with laBCC must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥ 10 mm, with MRI/CT scan or on color photographs.
. ECOG PS Score ≤ 2.
. Patients with adequate bone marrow, liver and renal function.
. Written informed consent obtained prior to any screening procedures.
. Patients are willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions.
. Females of childbearing potential agree to use contraception during treatment and for 20 months following the last dose; male patients (even after vasectomy) agree to use contraception during treatment and for 8 months after the last dose.
Exclusion criteria
. Subjects in the opinion of the investigator are immunosuppressed (e.g., organ transplant recipients, HIV, systemic invasive malignancy within past 5 years excluding Stage I cervical cancer, ductal carcinoma in situ of the breast or CLL stage 0, graft vs. host disease, etc.).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. LaBCC patients with skin lesions in multiple body locations will not be considered metastatic patients. LaBCC patients with positive (histological confirmation of BCC) regional nodal disease will be considered to have metastatic disease.
. Poorly controlled diabetes mellitus (as per Investigator's discretion in consultation with Sponsor's medical monitor).
. Major surgery within 4 weeks prior to study treatment.
. Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data.
. Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes.
. Patients who have previously been treated with systemic Sonidegib or with other Hh pathway inhibitors.
. Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy).