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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03333694
Other study ID # CCLL442X2201
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date December 15, 2017
Est. completion date November 1, 2018

Study information

Verified date September 2020
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this first in human and proof of concept study is to characterize the safety, tolerability and initial efficacy of CLL442 in patients with Squamous Cell Carcinoma in situ (SCCis) to enable further clinical development of CLL442.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. Written informed consent has been obtained. 2. Male and female patients, age = 18 to = 90 years (at the time of the screening visit). 3. 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. 4. 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. Exclusion Criteria: 1. 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. 2. 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; 3. 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. 4. History of recurrence of the target SCCis lesion. 5. 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. 6. Women of child-bearing potential, unless they are using at least basic methods of contraception during dosing of investigational drug. 7. Pregnant or nursing (lactating) women.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cutaneous Cream application
Cutaneous Cream application twice daily with experimental (CLL442)
Placebo Cutaneous Cream application
Cutaneous Cream application twice daily with placebo

Locations

Country Name City State
Australia Novartis Investigative Site Benowa Queensland
Australia Novartis Investigative Site Phillip Australian Capital Territory
Australia Novartis Investigative Site Westmead New South Wales
Belgium Novartis Investigative Site Leuven
Belgium Novartis Investigative Site Liege
United States Novartis Investigative Site Fountain Valley California
United States Novartis Investigative Site Gainesville Florida
United States Novartis Investigative Site Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on lesion free skin at Day 7 As part of safety and tolerability assessment, assess the incidence of adverse events (AE), serious adverse events (SAEs) in patients with SCCis treated with CLL442 or placebo on lesion free skin for 7 days Day 7
Primary Change in the size of One SCCis lesion area at Day 84 from Day 1 Area is measured by pen and ruler and standardized digital photography Day 1 and Day 84
Primary Change in the Local skin reactions severity score at Day 7 or Day 84 from Day 1 Local skin reactions severity score Day 1, Day 7, Day 84
Primary Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on SCCis lesion at Day 84 As part of safety and tolerability assessment, assess the incidence of adverse events (AE), serious adverse events (SAEs) in patients with SCCis treated with CLL442 or placebo on SCCis lesion area for 84 days. Day 84
Secondary CLL442 plasma concentration To evaluate the systemic pharmacokinetics of CLL442 Day 1 through Day 84
Secondary Time required to achieve 50% decrease in 1 lesion area. Part of efficacy assessment. 84 days
Secondary Time required to achieve complete SCCis 1 lesion clearance (censored by end of study visit). Part of efficacy assessment. 84 days
Secondary Percentage of pts with complete clearance at the end of the study, assessed visually and histologically Part of efficacy assessment. 84 days