Tailored Sonidegib Schedule After Complete Response in BCC

  • STATUS
    Recruiting
  • End date
    Jan 12, 2026
  • participants needed
    21
  • sponsor
    Gruppo Oncologico del Nord-Ovest
Updated on 28 March 2021

Summary

Adult patients with locally advanced BCC, not amenable to surgical treatment and who obtained a complete response (CR) to Hedgehog inhibitors are administered a tailored schedule of the study drug. The tailored schedule consists of a change in the time of drug assumption. It implements some weeks of assumption and some weeks of suspension of sonidegib rather than a continuous administration.

Description

One cycle of therapy is defined as 28 days of sonidegib. The patient will start with first schedule.

  • Treatment schedule 1 (TS1): assumption 14 days on and 14 days off. TS1 may be temporary interrupted for any grade 2 or 3 toxicity (excluding alopecia) until return to grade 1. If the patient experiences any grade 3 or 2 side effects lasting for more than 28 days, at treatment resumption they will start the TS2 schedule.
  • Treatment schedule 2 (TS2): assumption 7 days on and 21 days off. TS2 may be temporary interrupted for any grade 2 or 3 toxicity (excluding alopecia) until return to grade 1. If the patient experiences any grade 3 or 2 side effects lasting for more than 28 days, he/she is discontinued from the study.

If progression of disease is observed (during TS1 or TS2) the patient is discontinued from the study.

Details
Condition Locally Advanced Basal Cell Carcinoma
Treatment Sonidegib
Clinical Study IdentifierNCT04806646
SponsorGruppo Oncologico del Nord-Ovest
Last Modified on28 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written, signed informed consent, including consent to photographs of lesions
Age 18 years
Histologic confirmation of locally advanced BCC lesion
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
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Adequate hematopoietic capacity, defined as the following
Haemoglobin > 8.5 g/dl
Absolute neutrophil count (ANC) 1000/mmc
Platelet count 75,000/mmc
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
For women of childbearing potential, a negative pregnancy test within 7 days prior to commencement of dosing is required
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
Participant must agree to not breastfeed during the study and for 20 months after the last dose of study treatment
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
Agreement not to donate blood or blood products during the study and for at least 20 months after the last dose was received
For male patients, agreement not to donate sperm during treatment and for 6 months after the last dose was received

Exclusion Criteria

Metastatic BCC
Inability or unwillingness to swallow capsules
Inability or unwillingness to comply with study procedures
Pregnancy or lactation
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)
Uncontrolled medical illness, including advanced malignancies, at the discretion of the Investigator
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
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