A Randomized Investigator and Patient Blind Placebo-controlled Parallel Group First in Human and Proof of Concept Study to Evaluate the Safety Tolerability and Efficacy of CLL442 in Patients With Cutaneous Squamous Cell Carcinoma in Situ
Overview
- Phase
- Phase 1
- Intervention
- Cutaneous Cream application
- Conditions
- Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on SCCis lesion at Day 84
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility 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.
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.
Arms & Interventions
CLL442
Cutaneous Cream application twice daily
Intervention: Cutaneous Cream application
Placebo
Placebo Cutaneous Cream application twice daily
Intervention: Placebo Cutaneous Cream application
Outcomes
Primary Outcomes
Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on SCCis lesion at Day 84
Time Frame: 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.
Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on lesion free skin at Day 7
Time Frame: 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
Change in the size of One SCCis lesion area at Day 84 from Day 1
Time Frame: Day 1 and Day 84
Area is measured by pen and ruler and standardized digital photography
Change in the Local skin reactions severity score at Day 7 or Day 84 from Day 1
Time Frame: Day 1, Day 7, Day 84
Local skin reactions severity score
Secondary Outcomes
- CLL442 plasma concentration(Day 1 through Day 84)
- Percentage of pts with complete clearance at the end of the study, assessed visually and histologically(84 days)
- Time required to achieve complete SCCis 1 lesion clearance (censored by end of study visit).(84 days)
- Time required to achieve 50% decrease in 1 lesion area.(84 days)