Dose-Ranging Safety and Efficacy Study of Topical Creams Containing API 31510 for the Treatment of in Situ Cutaneous Squamous Cell Carcinoma

NCT00605709 | Withdrawn Phase 2 DMC

• 1 other identifier: CTL0208
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

• The primary efficacy endpoint will be the proportion of subjects with a complete response for the Intent-to-Treat (ITT) population.

  8 weeks

Secondary Outcomes (1)

• The secondary efficacy endpoint is the proportion of subjects with a partial response in the ITT population.

  8 weeks

Study Arms (4)

1

EXPERIMENTAL

Active Cream 3% ; AM \& PM

Drug: API 31510 Topical Cream

2

ACTIVE COMPARATOR

Placebo Cream AM; 3% Active Cream PM

Drug: API 31510 Topical Cream

3

ACTIVE COMPARATOR

Placebo Cream AM; 1.5% Active Cream PM

Drug: API 31510 Topical Cream

4

PLACEBO COMPARATOR

Placebo Cream AM \& PM

Drug: API 31510 Topical Cream

Interventions

API 31510 Topical Cream DRUG

Topical treatments to lesion twice daily of randomized treatments.

1; 2; 3; 4

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, desomoplastic 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: levulanic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, hyaluronic acid, imiquimod

Sponsors & Collaborators

• BPGbio: lead

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2008
• Last Updated: July 25, 2012

Record last verified: 2012-07