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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT03333694
Collaborator
(none)
40
Enrollment
8
Locations
2
Arms
10.5
Actual Duration (Months)
5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cutaneous Cream application
  • Drug: Placebo Cutaneous Cream application
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Double (Participant, Investigator)
Masking Description:
investigator and patient blinded
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 15, 2017
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: CLL442

Cutaneous Cream application twice daily

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

Placebo Cutaneous Cream application twice daily

Drug: Placebo Cutaneous Cream application
Cutaneous Cream application twice daily with placebo

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on lesion free skin at Day 7 [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

  2. Change in the size of One SCCis lesion area at Day 84 from Day 1 [Day 1 and Day 84]

    Area is measured by pen and ruler and standardized digital photography

  3. Change in the Local skin reactions severity score at Day 7 or Day 84 from Day 1 [Day 1, Day 7, Day 84]

    Local skin reactions severity score

  4. Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on SCCis lesion at Day 84 [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.

Secondary Outcome Measures

  1. CLL442 plasma concentration [Day 1 through Day 84]

    To evaluate the systemic pharmacokinetics of CLL442

  2. Time required to achieve 50% decrease in 1 lesion area. [84 days]

    Part of efficacy assessment.

  3. Time required to achieve complete SCCis 1 lesion clearance (censored by end of study visit). [84 days]

    Part of efficacy assessment.

  4. Percentage of pts with complete clearance at the end of the study, assessed visually and histologically [84 days]

    Part of efficacy assessment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Phoenix Arizona United States 85032
2 Novartis Investigative Site Fountain Valley California United States 92708
3 Novartis Investigative Site Gainesville Florida United States 32606
4 Novartis Investigative Site Phillip Australian Capital Territory Australia 2606
5 Novartis Investigative Site Westmead New South Wales Australia 2145
6 Novartis Investigative Site Benowa Queensland Australia 4217
7 Novartis Investigative Site Leuven Belgium 3000
8 Novartis Investigative Site Liege Belgium 4000

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03333694
Other Study ID Numbers:
  • CCLL442X2201
First Posted:
Nov 7, 2017
Last Update Posted:
Dec 11, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Cutaneous Squamous Cell Carcinoma (cSCC) in situ, mTOR kinase inhibitors, PI3K inhibitor.
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma in Situ

Study Results

No Results Posted as of Dec 11, 2020