Tailored Sonidegib Schedule After Complete Response in BCC

NCT04806646 | Unknown Phase 2

• 1 other identifier: SONIBEC
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Maintaining tailored treatment

  Proportion of patients maintaining the tailored treatment with sonidegib 12 months after enrolment into the study.

  12 months

Study Arms (1)

Single Arm Treatment

EXPERIMENTAL

One cycle of therapy is defined as 28 days of sonidegib. The patient will start with TS1 schedule. * 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. * 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.

Drug: Sonidegib

Interventions

Sonidegib DRUG

TS1: assumption 14 days on and 14 days off. TS2: assumption 7 days on and 21 days off.

Also known as: Odomzo

Single Arm Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Oncologico del Nord-Ovest: lead

Study Sites (1)

Asst Degli Spedali Civili Di Brescia

Brescia, Italy

RECRUITING

MeSH Terms

Interventions

sonidegib

Study Officials

• Paolo Bossi, MD

  Gono - ASST Spedali Civili Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariarita Arenella

CONTACT

+39 089 301545 |; sonibec@cr-technology.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: January 12, 2021
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2026
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)