Squamous Cell CarcinomaPhase 1/2NCT00652080

An Open-Label Safety Study of API 31510 in a Topical Cream for in Situ Cutaneous Squamous Cell Carcinoma (SCCIS)

A Phase 1/2 study testing API 31510 in people with Squamous Cell Carcinoma, run by BPGbio at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine the safety and tolerability of pharmaceutical compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell carcinoma by Compound 31510 topical cream. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Cell Carcinoma
What is being tested?: API 31510
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 5 sitesUnited States
Study dates: Jun 2008to Jan 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female adults > 18 years of age
Primary, histologically confirmed SCCIS with a minimum area of 0.5 cm2 and with a maximum diameter of 2.0 cm target SCCIS lesion suitable for excision
Histological diagnosis made no more than 4 weeks prior to the screening visit
Histological biopsy removed 25% or less of the target lesion
No other dermatological disease in the SCCIS target site or surrounding area
Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period. Willing to refrain from washing the treated area for at least 8 hours following the application of study medication

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Willing to refrain from exposure to direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study
Laboratory values for the tests listed in the Study Schedule on page 2 within the reference ranges as defined by the central laboratory, or "out of range" test results that are clinically acceptable to the investigator.
Ability to follow study instructions and likely to complete all study requirements
Written informed consent obtained, including consent for tissue to be examined and stored by the central dermatopathologist.
Written consent to allow photographs of the target SCCIS lesion to be used as part of the study data
For females of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy)

Who cannot join

Pregnant or lactating
Presence of known or suspected systemic cancer
Histological evidence of nBCC, sBCC, or any other tumor in the biopsy specimen
Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic or micronodular growth patterns in the biopsy specimen
History of recurrence of the target SCCIS lesion
Evidence of dermatological disease or confounding skin condition in the treatment area, e.g., BCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa

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Concurrent disease or treatment that suppresses the immune system
Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the patient at undue risk
Known sensitivity to any of the ingredients in the study medication
Use of a tanning parlor or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the course of the study
Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit
Use of systemic retinoids within the 6 months prior to the screening period
Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period
Use of topical immunomodulators within 2 cm of the target SCCIS lesion within the 4 weeks prior to the screening period
Treatment with the following topical agents within the 4 weeks prior to the screening visit; levulinic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, hyaluronic acid, imiquimod
Undergone a facial resurfacing procedure, i.e., chemical peel, laser resurfacing, dermabrasion, within the 6 months prior to the screening visit, if the target SCCIS lesion is on the face
Treatment with liquid nitrogen, surgical excision or curettage within 2cm of the target SCCIS lesion during the 4 weeks prior to the screening visit
Elective surgery within 4 weeks prior to the screening visit, during the study, or 4 weeks after the treatment period
Evidence of current chronic alcohol or drug abuse
Current enrollment in an investigational drug or device or participation in such a study within 4 weeks of the screening visit
In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Glazer Dermatology
Buffalo Grove, Illinois, 60089
Burke Pharmaceuticals
Hot Springs, Arkansas, 71913
Education and Research Foundation
Lynchburg, Virginia, 24501
Skin Surgery Medical Group, Inc.
San Diego, California, 92117
Long Island Skin Cancer and Dermatalogic Surgery, PC
Smithtown, New York, 11787

Other trials in United States

About this study

Conditions: Squamous Cell Carcinoma
Being tested: API 31510
Medical subject headings: Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

API 31510Drug
Topical Cream; 3% active; AM \& PM application

Study groups in NCT00652080
Study group	Role	What they receive
1	Experimental	Active Cream 3%; AM \& PM Receives: Drug: API 31510

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
To determine the safety and tolerability of API 31510 cream 3%, topically applied to in situ cutaneous squamous cell carcinomas (SCCIS).
Measured: 6 weeks

Secondary outcomes (1)

Percentage of Participants With a Complete Response
To obtain a preliminary determination of the efficacy of API 31510 cream 3%,topically applied to in situ cutaneous squamous cell carcinomas.
The subject was considered to have had a complete response only if the histological examination of the target lesion was negative.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Jan 2010

First posted3 Apr 2008 (estimated)
Study startJun 2008
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00652080
Sponsor's protocol ID: CTL0408
Status last verified: Feb 2019
First submitted: 31 Mar 2008
Last updated: 5 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Squamous Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Safety Study of API 31510 in a Topical Cream for in Situ Cutaneous Squamous Cell Carcinoma (SCCIS)
ClinicalTrials.gov ID: NCT00652080
Acronym / sponsor ID: CTL0408
Conditions: Squamous Cell Carcinoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: BPGbioIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 3 Apr 2008 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: API 31510Active Cream 3%; AM \& PM

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Male or female adults > 18 years of age
Primary, histologically confirmed SCCIS with a minimum area of 0.5 cm2 and with a maximum diameter of 2.0 cm target SCCIS lesion suitable for excision
Histological diagnosis made no more than 4 weeks prior to the screening visit
Histological biopsy removed 25% or less of the target lesion
No other dermatological disease in the SCCIS target site or surrounding area

Key exclusion criteria (21 listed)

Pregnant or lactating
Presence of known or suspected systemic cancer
Histological evidence of nBCC, sBCC, or any other tumor in the biopsy specimen
Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic or micronodular growth patterns in the biopsy specimen
History of recurrence of the target SCCIS lesion

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
API 31510Topical Cream; 3% active; AM \& PM application	Drug	1

Primary outcome

Number of Participants With Adverse Events
Time frame: 6 weeks
To determine the safety and tolerability of API 31510 cream 3%, topically applied to in situ cutaneous squamous cell carcinomas (SCCIS).

1 secondary outcome

Percentage of Participants With a Complete Response
Time frame: 6 weeks

Results and safety

Results posted to the registry on 15 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
API 31510 Topical Cream	35	31

Primary outcome: Number of Participants With Adverse Events

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Safety Population n = 35
Subjects with an AE (Mild)	10
Subjects with an AE (Moderate)	4
Subjects with an AE (Severe)	1
Subjects without an AE	20

Population analysed: Safety Population: All subjects who took at least one dose of the investigational product.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Safety Population	1 of 35 (2.9%)	22 of 35 (62.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Squamous Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 2
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RecruitingObservational study
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RecruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing API 31510 in people with Squamous Cell Carcinoma, run by BPGbio at 5 sites in United States.

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 12 inclusion and 21 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: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00652080.

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 5 Mar 2019.