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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03333694
Recruitment Status : Terminated (The study fully enrolled and completed after last patient completed the study)
First Posted : November 7, 2017
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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
Cutaneous Squamous Cell Carcinoma in Situ (CSCCis) Drug: Cutaneous Cream application Drug: Placebo Cutaneous Cream application Phase 1

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Study Type : Interventional  (Clinical Trial)
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.
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 : December 15, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. CLL442 plasma concentration [ Time Frame: Day 1 through Day 84 ]
    To evaluate the systemic pharmacokinetics of CLL442

  2. Time required to achieve 50% decrease in 1 lesion area. [ Time Frame: 84 days ]
    Part of efficacy assessment.

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

  4. Percentage of pts with complete clearance at the end of the study, assessed visually and histologically [ Time Frame: 84 days ]
    Part of efficacy assessment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333694


Locations
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United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85032
United States, California
Novartis Investigative Site
Fountain Valley, California, United States, 92708
United States, Florida
Novartis Investigative Site
Gainesville, Florida, United States, 32606
Australia, Australian Capital Territory
Novartis Investigative Site
Phillip, Australian Capital Territory, Australia, 2606
Australia, New South Wales
Novartis Investigative Site
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Novartis Investigative Site
Benowa, Queensland, Australia, 4217
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Liege, Belgium, 4000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03333694    
Other Study ID Numbers: CCLL442X2201
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cutaneous Squamous Cell Carcinoma (cSCC) in situ, mTOR kinase inhibitors, PI3K inhibitor.
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell