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A phase II study of Sonidegib in Nevoid Basal Cell Carcinoma Syndrome (Gorlin) syndrome and sporadic BCC patients in EADO stage IIb. SIBLINGS TRIAL
EU CTIS ID: 2024-515989-14-00
What this study is testing
Treatment compliance in an NBCCS - population / sporadic BCC patients in EADO stage IIb treated for 16 weeks with daily sonidegib followed by a pulsed dosing schedule maintained for the next 24 weeks.
- 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
- Be willing and able to provide written informed consent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- One of the following conditions: - subject with established diagnosis of NBCCS; - subject with common\sporadic BCC.
- Clinical stage IIB according to EADO Classification [Very high number of common BCC (>10) or multiple complex BCC (> 5) in the setting of apparently sporadic cases or in Gorlin syndrome. When at least 1 of the multiple BCC can be classified III or IV, the patient will be classified accordingly, and not IIB].
- Being deemed difficult to treat: not amenable for surgery or RT after the evaluation of a multidisciplinary team involving at least a dermatologist and a medical oncologist and therefore eligible for HHI therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- Distant metastatic disease (M1), visceral and/or distant nodal.
- Prior HHI therapy in the last 2 years.
- Received previous systemic treatment for BCC; local therapy (e.g. imiquimod) are allowed.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Hypersensitivity to sonidegib or any of its excipients.
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, 18-64 years, 65+ 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.