Study on Sonidegib for Patients with Locally Advanced Basal Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of skin cancer called locally advanced basal cell carcinoma (BCC). The treatment being tested is a medication called sonidegib, which is taken as a hard capsule. The purpose of the study is to see how well patients can follow a specific treatment plan with sonidegib after they have already responded well to a similar type of treatment.

Participants in the study will take sonidegib according to a tailored schedule. This means they will have specific periods when they take the medication and periods when they do not. The study will last for up to two years, and during this time, researchers will monitor how well patients stick to the treatment plan and how their condition responds. The study will also look at the safety of the treatment and any side effects that may occur.

Throughout the study, patients will have regular check-ups to assess their health and the effectiveness of the treatment. This will include taking images of the affected skin areas to see how they change over time. The study aims to provide valuable information on how to best manage treatment for patients with locally advanced basal cell carcinoma using sonidegib.

1 enrollment

Upon joining the study, the participant will provide a written, signed informed consent, which includes consent to photographs of lesions.

For women of childbearing potential, a negative pregnancy test is required within 7 days prior to the start of the treatment.

2 treatment initiation

The participant will begin treatment with Odomzo 200 mg hard capsules, which contain the active substance sonidegib.

The medication is taken orally, following a tailored schedule: either 14 days on treatment followed by 14 days off, or 7 days on treatment followed by 21 days off.

3 treatment duration

The primary goal is to maintain the tailored treatment with sonidegib for 12 months after enrollment.

The study will also evaluate the proportion of participants maintaining treatment 2 years after achieving a complete response.

4 monitoring and assessments

Regular assessments will be conducted to monitor compliance with the study treatment and to evaluate any side effects.

Quality of life will be measured monthly using the Edmonton Symptom Assessment System scales.

Dermoscopic images of the lesion area will be obtained to track changes during the treatment period.

5 post-treatment follow-up

Participants are required to agree not to donate blood or blood products during the study and for at least 20 months after the last dose.

Male participants must agree not to donate sperm during treatment and for 6 months after the last dose.

Who Can Join the Study?

Provide a written and signed consent form, including permission to take photographs of skin lesions.
For women who can have children, a negative pregnancy test is required within 7 days before starting the treatment.
Agree not to breastfeed during the study and for 20 months after the last dose of the study treatment.
For male participants with female partners who can have children, agree to use a condom during sexual intercourse while being treated with the study drug and for 6 months after the last dose, even if you have had a vasectomy.
Agree not to donate blood or blood products during the study and for at least 20 months after the last dose.
For male participants, agree not to donate sperm during treatment and for 6 months after the last dose.
Be at least 18 years old.
Have a confirmed diagnosis of locally advanced basal cell carcinoma (BCC).
Currently receiving treatment with a Hedgehog inhibitor for BCC that has returned after three or more surgeries, or if surgery is unlikely to be successful, or if the BCC is large, bleeding, or infected, or if surgery would cause significant harm or disfigurement, or if there are multiple BCCs that cannot be treated with surgery for medical reasons.
Have shown a complete response to a Hedgehog inhibitor within the 3 months before the screening, confirmed by two consecutive imaging tests and visual and dermoscopic examinations.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which means you are fully active or have some symptoms but do not need bed rest for more than half of the day.
Have adequate blood cell levels, including hemoglobin greater than 8.5 g/dl, absolute neutrophil count (ANC) of at least 1000/mmc, and platelet count of at least 75,000/mmc.
Have adequate liver and kidney function, with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels no more than 3 times the upper limit of normal, total bilirubin no more than 1.5 times the upper limit of normal (or within 3 times the upper limit for those with Gilbert syndrome), and a calculated serum creatinine clearance (CrCl) of at least 30 mL/min.

Who Cannot Join the Study?

Patients who have not previously achieved a complete response (CR) with any inhibitor of the Hedgehog pathway. Hedgehog pathway is a series of signals in the body that can affect cell growth and development.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Universita Degli Studi Di Brescia	Brescia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	26.01.2021

Trial locations

Investigated drugs:

Sonidegib

Sonidegib is a medication used in this clinical trial to treat a type of skin cancer called basal cell carcinoma, which is locally advanced. This medication works by blocking a specific pathway in the body known as the Hedgehog pathway. This pathway is often active in certain types of cancer, and by blocking it, sonidegib can help stop the cancer cells from growing and spreading. In this trial, the focus is on adjusting the treatment schedule of sonidegib to improve how well patients stick to their treatment plan after they have achieved a complete response, meaning the cancer has disappeared following previous treatment with any Hedgehog pathway inhibitor.

Investigated diseases:

Basal cell carcinoma

Locally advanced basal cell carcinoma – This is a type of skin cancer that occurs when basal cell carcinoma, the most common form of skin cancer, grows deeper into the skin and surrounding tissues. It typically develops in areas exposed to the sun, such as the face and neck. The disease progresses slowly and can cause significant local damage if not managed. It often appears as a slightly transparent bump on the skin, though it can take other forms. As it advances, it may cause symptoms like bleeding, oozing, or crusting in the affected area. Despite its potential for local invasion, it rarely spreads to other parts of the body.

Trial ID:

2024-516797-29-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Sonidegib for Patients with Locally Advanced Basal Cell Carcinoma

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