A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of B… (NCT03534947) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma
Australia16 participantsStarted 2019-07-23
Plain-language summary
In this study, patients with BCC will be given neoadjuvant treatment with a drug called sonidegib. Sonidegib is a daily tablet usually given for BCC that cannot be removed by surgery or that has spread through the body. The study aims to see if sonidegib given for 12 weeks will reduce the size of tumours so surgery results in less scarring or may be avoided, with only short term topical treatment required to treat remaining tumour.
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:
* ≥18 years of age.
* Written informed consent.
* Histologically confirmed, resectable, invasive basal cell carcinoma.
* Site and size of BCC considered to be in a cosmetically challenging position for surgery.
* Patient has expressed concerns of the cosmetic outcome of surgery.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* Ability to swallow and retain oral medication.
* Anticipated life expectancy of \> 12 months.
* Adequate organ function as demonstrated by blood tests.
* Willing to abstain from blood donations for 20 months from the last dose of sonidegib.
* Men with female partner of childbearing potential to use effective contraception from 14 days prior to study treatment until 6 months after the last dose.
* Female patients with active contraception or no menstrual cycle for \>12 months
Exclusion Criteria:
* Inoperable basal cell carcinoma tumours.
* A concurrent cancer diagnosis requiring any systemic anti-cancer therapy.
* Serious or unstable pre-existing medical conditions or other conditions or laboratory abnormalities that could interfere with the patient's safety, consent, or compliance.
* History of malabsorption or other conditions that would interfere with the absorption of sonidegib.
* Known psychiatric or substance abuse disorders that would interfere with cooperation and compliance with the requirements of the trial.
* Prior treatment with hedgehog pathway inhibitors.
* Concomitant medications that may result i…
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.
What they're measuring
1
Neoadjuvant treatment response determined by optical coherence tomography