Tailored Sonidegib Schedule After Complete Response in BCC (NCT04806646) | Clinical Trial Compass
UnknownPhase 2
Tailored Sonidegib Schedule After Complete Response in BCC
Italy21 participantsStarted 2021-01-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
✓. 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:
✓. Adequate hepatic and renal function, defined as the following:
Exclusion criteria
✕. Metastatic BCC.
✕. Inability or unwillingness to swallow capsules.
✕. Inability or unwillingness to comply with study procedures.
. 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.