Squamous Cell Carcinoma
Conditions
Brief 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.
Interventions
DRUGAPI 31510
Topical Cream; 3% active; AM & PM application
Sponsors
BPGbio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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)
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 6 weeks | To determine the safety and tolerability of API 31510 cream 3%, topically applied to in situ cutaneous squamous cell carcinomas (SCCIS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Complete Response | 6 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Subjects were required to have at least one histologically-confirmed SCCIS lesion that was suitable for excision, ie, to have a lesion with a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm.
Participants by arm
| Arm | Count |
|---|---|
| API 31510 Topical Cream Active Cream 3%; AM & PM
API 31510: Topical Cream; 3% active; AM & PM application | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | API 31510 Topical Cream |
|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 35 |
| serious Total, serious adverse events | 1 / 35 |
Outcome results
Primary
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).
Time frame: 6 weeks
Population: Safety Population: All subjects who took at least one dose of the investigational product.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Safety Population | Number of Participants With Adverse Events | Subjects without an AE | 20 Participants |
| Safety Population | Number of Participants With Adverse Events | Subjects with an AE (Mild) | 10 Participants |
| Safety Population | Number of Participants With Adverse Events | Subjects with an AE (Moderate) | 4 Participants |
| Safety Population | Number of Participants With Adverse Events | Subjects with an AE (Severe) | 1 Participants |
Secondary
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.
Time frame: 6 weeks
Population: Intent-to-Treat (ITT) Population: All subjects who were dispensed the study drug were included in this population.~Per Protocol (PP) Population: All subjects who had SCCIS confirmed via histological results at baseline, had a Week 6 histological examination, and did not miss any interim visits.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Safety Population | Percentage of Participants With a Complete Response | 8 Participants |
| PP Population | Percentage of Participants With a Complete Response | 5 Participants |