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Safety, Tolerability, and Efficacy Study of CLL442 in Patients With Cutaneous Squamous Cell Carcinoma in Situ (SCCis)

NCT ID: NCT03333694

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2018-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)

Keywords

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Cutaneous Squamous Cell Carcinoma (cSCC) in situ, mTOR kinase inhibitors, PI3K inhibitor.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A first in human,proof of concept study. The study is investigator-and patient-blinded, randomized, placebo-controlled study in patients with SCCis, to assess safety, tolerability and initial efficacy of CLL442 after up to 84 days twice daily application of CLL442 or placebo on one lesion.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
investigator and patient blinded

Study Groups

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CLL442

Cutaneous Cream application twice daily

Group Type EXPERIMENTAL

Cutaneous Cream application

Intervention Type DRUG

Cutaneous Cream application twice daily with experimental (CLL442)

Placebo

Placebo Cutaneous Cream application twice daily

Group Type PLACEBO_COMPARATOR

Placebo Cutaneous Cream application

Intervention Type DRUG

Cutaneous Cream application twice daily with placebo

Interventions

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Cutaneous Cream application

Cutaneous Cream application twice daily with experimental (CLL442)

Intervention Type DRUG

Placebo Cutaneous Cream application

Cutaneous Cream application twice daily with placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Phoenix, Arizona, United States

Site Status

Novartis Investigative Site

Fountain Valley, California, United States

Site Status

Novartis Investigative Site

Gainesville, Florida, United States

Site Status

Novartis Investigative Site

Phillip, Australian Capital Territory, Australia

Site Status

Novartis Investigative Site

Westmead, New South Wales, Australia

Site Status

Novartis Investigative Site

Benowa, Queensland, Australia

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Liège, , Belgium

Site Status

Countries

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United States Australia Belgium

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17537

Results for CCLL442X2201 can be found on the Novartis Clinical Trial Results Website

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=482

A Plain Language Trial Summary is available on novartisclinicatrials.com

Other Identifiers

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CCLL442X2201

Identifier Type: -

Identifier Source: org_study_id