Cutaneous Squamous Cell Carcinoma in situ (SCCis) MedDRA version: 20.0 Level: PT Classification code 10041834 Term: Squamous cell carcinoma of skin System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: CLL442
Product Code: CLL442
Pharmaceutical Form: Cream
INN or Proposed INN: Not established
Current Sponsor code: CLL442
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent has been obtained. - Male and female patients, age = 18 to = 90 years (at the time of the screening visit). - A primary, clinically diagnosed and histologically confirmed cutaneous SCC in situ lesion, with or without the involvement of the follicular unit, and histologically diagnosed within 30 days of the screening visit. The post-biopsy residual SCCis lesion must be visually evident and at least 3 mm in either length or width. - The lesion must be located in a place easily accessible for topical application by the patient or their caregiver, excluding the genitals, perianal area, sub-ungual area, eyelids, ear and must be >1 cm away from the eyes and mouth. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Evidence of dermatological disease or histological evidence of a confounding skin condition in the treatment area, including but not limited to BCC, worse level/grade of SCC, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa, verrucous lesions or any other tumor in the biopsy specimen. Lesions with atypical histology such as: spindle cell SCC, acantholytic SCC, clear cell SCC, adenosquamous SCC, desmoplastic SCC or lesions that have been present for a short time and have been fast growing. - Treatment of the target SCCis lesion within 8 weeks of screening visit by any of the following treatments: Liquid nitrogen, Photochemotherapy (PUVA), Long wave ultra violet radiation (UVB light), surgical excision or curettage within 1 cm of target lesion.; Systemic retinoids.; Ionizing radiation or interlesional injections or; Undergone a facial resurfacing procedure, i.e., chemical peel, laser resurfacing, dermabrasion, within the target lesion; - Treatment with the following topical agents within the 4 weeks prior to the screening visit: Levulanic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, hyaluronic acid, imiquimod. - History of recurrence of the target SCCis lesion. - Systemic use of immunosuppressive drugs within 4 weeks prior to screening visit or during the treatment period - Photodynamic therapy or immunomodulators, cytotoxic drugs, or interferon/interferon inducers within 4 weeks prior to study entry or expected during the study. - Women of child-bearing potential, unless they are using at least basic methods of contraception during dosing of investigational drug. - Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the safety and tolerability of CLL442 in patients with SCCis on both lesion free skin and SCCis lesions. - To evaluate the initial efficacy of CLL442 on reduction of lesion area in patients with SCCis. ; Secondary Objective: - To evaluate systemic pharmacokinetics (sparse sampling PK) of CLL442. - To assess the efficacy of CLL442 on multiple measures of SCCis lesions. ;Timepoint(s) of evaluation of this end point: As above; Primary end point(s): - Effects of CLL442 on lesion free skin and SCCis lesions, incidence of adverse events (AE), serious adverse events (SAEs); changes in ECG parameters, vital signs, VAS, local skin reactions severity score, biochemistry, hematology, urinalysis. - One lesion area as measured by pen and ruler and standardized digital photography at Day 84 (week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Measurement of CLL442 concentration in plasma during treatment. - Time required to achieve 50% decrease in one lesion area. - Time required to achieve complete SCCis one lesion clearance (censored by end of study visit). - Percentage of patients with complete clearance at the end of the study, assessed visually and histologically. ;Timepoint(s) of evaluation of this end point: As above | — |
Countries
Australia, Belgium, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed