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

NCT00652080 | Completed Phase 1 Results DMC

• 1 other identifier: CTL0408
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

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.

Conditions

Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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).

  6 weeks

Secondary Outcomes (1)

• Percentage of Participants With a Complete Response

  6 weeks

Study Arms (1)

1

EXPERIMENTAL

Active Cream 3%; AM \& PM

Drug: API 31510

Interventions

API 31510 DRUG

Topical Cream; 3% active; AM \& PM application

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BPGbio: lead

Study Sites (5)

Burke Pharmaceuticals

Hot Springs, Arkansas, 71913, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Glazer Dermatology

Buffalo Grove, Illinois, 60089, United States

Location

Long Island Skin Cancer and Dermatalogic Surgery, PC

Smithtown, New York, 11787, United States

Location

Education and Research Foundation

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Results Point of Contact

• Title: Nathaniel DiTommaso
• Organization: Berg LLC

nate.ditommaso@berghealth.com

617-588-1002

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 5, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-02

Locations

US (5)