Tailored Sonidegib Schedule After Complete Response in BCC

Launched by GRUPPO ONCOLOGICO DEL NORD-OVEST · Mar 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to use the medication sonidegib in adults with locally advanced basal cell carcinoma (BCC) that can't be treated with surgery. The trial is for patients who have already responded well to sonidegib, meaning their cancer showed a complete response in the last three months. Instead of taking the medication continuously, participants will follow a tailored schedule where they will take sonidegib for a few weeks, followed by a break for several weeks. This approach aims to see if it can help maintain the benefits of the treatment while possibly reducing side effects.

To join the trial, patients must be at least 18 years old, have a confirmed diagnosis of locally advanced BCC, and have shown a complete response to sonidegib. Participants will need to agree to certain health checks and follow specific guidelines, especially regarding pregnancy and contraception. Throughout the trial, participants can expect regular check-ups and monitoring to track their health and response to the treatment. It's important to know that this study is currently recruiting patients, so there may be an opportunity for those who qualify to take part in this innovative treatment approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written, signed informed consent, including consent to photographs of lesions.
• • 2. Age ≥ 18 years.
• • 3. Histologic confirmation of locally advanced BCC lesion.
• 4. Patients with BCCs already in treatment with Hedgehog inhibitor sonidegib 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
• • 5. Patient having shown a complete response (CR) to Hedgehog inhibitor sonidegib 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.
• • 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• 7. Adequate hematopoietic capacity, defined as the following:
• • Haemoglobin \> 8.5 g/dl
• • Absolute neutrophil count (ANC) ≥ 1000/mmc
• • Platelet count ≥ 75,000/mmc
• 8. 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
• • 9. For women of childbearing potential, a negative pregnancy test within 7 days prior to commencement of dosing is required
• • 10. Women of child-bearing potential must use two methods of acceptable contraception including one highly effective method and a barrier method, as directed by their physician, during treatment and for at least 20 months after completion of study treatment. Highly effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception, or intra-uterine devices). Check Appendix B for details.
• • 11. Participant must agree to not breastfeed during the study and for 20 months after the last dose of study treatment.
• • 12. 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.
• • 13. Agreement not to donate blood or blood products during the study and for at least 20 months after the last dose was received.
• • 14. For male patients, agreement not to donate sperm during treatment and for 6 months after the last dose was received.
• Exclusion Criteria:
• • 1. Metastatic BCC.
• • 2. Inability or unwillingness to swallow capsules.
• • 3. Inability or unwillingness to comply with study procedures.
• • 4. Pregnancy or lactation.
• • 5. 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).
• • 6. Uncontrolled medical illness, including advanced malignancies, at the discretion of the Investigator.
• • 7. 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.