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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03333694




Registration number
NCT03333694
Ethics application status
Date submitted
12/10/2017
Date registered
7/11/2017
Date last updated
11/12/2020

Titles & IDs
Public title
Safety, Tolerability, and Efficacy Study of CLL442 in Patients With Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
Scientific 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
Secondary ID [1] 0 0
CCLL442X2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Squamous Cell Carcinoma in Situ (CSCCis) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Cervical (cervix)
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cutaneous Cream application
Treatment: Drugs - Placebo Cutaneous Cream application

Experimental: CLL442 - Cutaneous Cream application twice daily

Placebo Comparator: Placebo - Placebo Cutaneous Cream application twice daily


Treatment: Drugs: Cutaneous Cream application
Cutaneous Cream application twice daily with experimental (CLL442)

Treatment: Drugs: Placebo Cutaneous Cream application
Cutaneous Cream application twice daily with placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on lesion free skin at Day 7
Timepoint [1] 0 0
Day 7
Primary outcome [2] 0 0
Change in the size of One SCCis lesion area at Day 84 from Day 1
Timepoint [2] 0 0
Day 1 and Day 84
Primary outcome [3] 0 0
Change in the Local skin reactions severity score at Day 7 or Day 84 from Day 1
Timepoint [3] 0 0
Day 1, Day 7, Day 84
Primary outcome [4] 0 0
Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on SCCis lesion at Day 84
Timepoint [4] 0 0
Day 84
Secondary outcome [1] 0 0
CLL442 plasma concentration
Timepoint [1] 0 0
Day 1 through Day 84
Secondary outcome [2] 0 0
Time required to achieve 50% decrease in 1 lesion area.
Timepoint [2] 0 0
84 days
Secondary outcome [3] 0 0
Time required to achieve complete SCCis 1 lesion clearance (censored by end of study visit).
Timepoint [3] 0 0
84 days
Secondary outcome [4] 0 0
Percentage of pts with complete clearance at the end of the study, assessed visually and histologically
Timepoint [4] 0 0
84 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2018
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - Phillip
Recruitment hospital [2] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [3] 0 0
Novartis Investigative Site - Benowa
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Belgium
State/province [5] 0 0
Liege

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03333694
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03333694