Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)Phase 1NCT03333694
Safety, Tolerability, and Efficacy Study of CLL442 in Patients With Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
A Phase 1 study testing Cutaneous Cream application in people with Cutaneous Squamous Cell Carcinoma in Situ (CSCCis), run by Novartis Pharmaceuticals at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)
- What is being tested?
- Cutaneous Cream application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 15 Dec 2017to 1 Nov 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States3 sites
Novartis Investigative Site
Fountain Valley, California, 92708
Novartis Investigative Site
Gainesville, Florida, 32606
Novartis Investigative Site
Phoenix, Arizona, 85032
Australia3 sites
Novartis Investigative Site
Benowa, Queensland, 4217
Novartis Investigative Site
Phillip, Australian Capital Territory, 2606
Novartis Investigative Site
Westmead, New South Wales, 2145
Belgium2 sites
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
About this study
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
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.
- Being tested
- Cutaneous Cream application, Placebo Cutaneous Cream application
- Keywords
- Cutaneous Squamous Cell Carcinoma (cSCC) in situ, mTOR kinase inhibitors, PI3K inhibitor.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutaneous Cream applicationDrug
Cutaneous Cream application twice daily with experimental (CLL442)
Placebo Cutaneous Cream applicationDrug
Cutaneous Cream application twice daily with placebo
| Study group | Role | What they receive |
|---|---|---|
| CLL442 | Experimental | Cutaneous Cream application twice daily Receives: Drug: Cutaneous Cream application |
| Placebo | Placebo comparator | Placebo Cutaneous Cream application twice daily Receives: Drug: Placebo Cutaneous Cream application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on lesion free skin at 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
Measured: Day 7
Change in the size of One SCCis lesion area at Day 84 from Day 1
Area is measured by pen and ruler and standardized digital photography
Measured: Day 1 and Day 84
Change in the Local skin reactions severity score at Day 7 or Day 84 from Day 1
Local skin reactions severity score
Measured: Day 1, Day 7, Day 84
Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on SCCis lesion at 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.
Measured: Day 84
Secondary outcomes (4)
CLL442 plasma concentration
To evaluate the systemic pharmacokinetics of CLL442
Measured: Day 1 through Day 84
Time required to achieve 50% decrease in 1 lesion area.
Part of efficacy assessment.
Measured: 84 days
Time required to achieve complete SCCis 1 lesion clearance (censored by end of study visit).
Part of efficacy assessment.
Measured: 84 days
Percentage of pts with complete clearance at the end of the study, assessed visually and histologically
Part of efficacy assessment.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start15 Dec 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Why it stopped: The study fully enrolled and completed after last patient completed the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333694
- Sponsor's protocol ID
- CCLL442X2201
- Status last verified
- Sep 2020
- First submitted
- 12 Oct 2017
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03333694
- Acronym / sponsor ID
- CCLL442X2201
- Keywords
- Cutaneous Squamous Cell Carcinoma (cSCC) in situ, mTOR kinase inhibitors, PI3K inhibitor.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study fully enrolled and completed after last patient completed the study
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CLL442 | Experimental | Drug: Cutaneous Cream applicationCutaneous Cream application twice daily |
| Placebo | Placebo comparator | Drug: Placebo Cutaneous Cream applicationPlacebo Cutaneous Cream application twice daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutaneous Cream applicationCutaneous Cream application twice daily with experimental (CLL442) | Drug | CLL442 |
| Placebo Cutaneous Cream applicationCutaneous Cream application twice daily with placebo | Drug | Placebo |
Primary outcome
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
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.
4 secondary outcomes
CLL442 plasma concentration
Time frame: Day 1 through Day 84
Time required to achieve 50% decrease in 1 lesion area.
Time frame: 84 days
Time required to achieve complete SCCis 1 lesion clearance (censored by end of study visit).
Time frame: 84 days
Percentage of pts with complete clearance at the end of the study, assessed visually and histologically
Time frame: 84 days
Results and safety
The study was stopped early (reason given: The study fully enrolled and completed after last patient completed the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Results for CCLL442X2201 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cutaneous Cream application in people with Cutaneous Squamous Cell Carcinoma in Situ (CSCCis), run by Novartis Pharmaceuticals at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study fully enrolled and completed after last patient completed the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AE), serious adverse events (SAEs) of CLL442 on lesion free skin at Day 7 (time frame: Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.