An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC

NCT04155190 | Terminated Phase 2 FDA Drug

• 1 other identifier: Pelle-926-203
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 14

Brief Summary

This is a multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with non-Gorlin HF-BCC (high-frequency basal cell carcinoma). Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender. The primary endpoint is the number of nSEB (surgically eligible basal cell carcinoma) that develop on the face over the 9 month period. The primary end point will be assessed by imaging and tracking of BCCs consistently throughout the study in order to identify nSEBs.

Conditions

Recurrent Basal Cell Carcinoma

Keywords

High Frequency Basal Cell Carcinoma; non-gorlin; HF-BCC; Bazex-Dupré-Christol Syndrome; Rombo Syndrome; Oley Syndrome; Xeroderma Pigmentosum (XP) Syndrome; BCC; SEB; Hedgehog inhibitor; Basal Cell Nevus Syndrome; Basal Cell Carcinoma; Surgically Eligible Basal Cell Carcinoma; patidegib; HFBCC; HHI

Outcome Measures

Primary Outcomes (1)

• Number of new surgically eligible BCCs (nSEBs)

  Baseline through Month 9

Secondary Outcomes (1)

• Number of treatment emergent adverse events assessed with means and standard errors or proportions

  Baseline through Month 9

Study Arms (2)

Patidegib Topical Gel, 2%

EXPERIMENTAL

Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months

Drug: Patidegib Topical Gel, 2%

Patidegib Topical Gel, Vehicle

ACTIVE COMPARATOR

Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months

Drug: Patidegib Topical Gel, Vehicle

Interventions

Patidegib Topical Gel, 2% DRUG

Patidegib Topical Gel, 2%

Also known as: IP

Patidegib Topical Gel, 2%

Patidegib Topical Gel, Vehicle DRUG

Patidegib Topical Gel, Vehicle

Also known as: IP, Vehicle

Patidegib Topical Gel, Vehicle

Eligibility Criteria

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

You may qualify if:

• The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Screening and Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter \<5 mm present on the face prior to Screening and Randomization (Baseline/Day 1).
• The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator.

You may not qualify if:

• The subject has been previously diagnosed with Gorlin syndrome
• On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome.
• Patients with a family history of medulloblastoma
• The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
• The subject has uncontrolled systemic disease.
• The subject has been treated for invasive cancer within the past 5 years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) Stage 0.

Sponsors & Collaborators

• Sol-Gel Technologies, Ltd.: lead

Study Sites (14)

Axiom Research, LLC

Apple Valley, California, 92307, United States

Location

Axiom Research, LLC

Colton, California, 92324, United States

Location

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

The Dermatology Center of Newport

Newport Beach, California, 92660, United States

Location

Palm Beach Dermatology Research

Delray Beach, Florida, 33484, United States

Location

Leavitt Medical Associates of Florida

Ormond Beach, Florida, 32174, United States

Location

PellePharm Investigative Site

Saint Augustine, Florida, 32080, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

PellePharm Investigative Site

Henderson, Nevada, 89052, United States

Location

Skin Laser and Surgery Specialists of NY&NJ

Hackensack, New Jersey, 07601, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Utah

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Rombo syndrome; Xeroderma Pigmentosum; Syndrome; Basal Cell Nevus Syndrome

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Precancerous Conditions; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Pigmentation Disorders; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplastic Syndromes, Hereditary; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Abnormalities, Multiple

Study Officials

• VP, Clinical Operations

  PellePharm, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: As a double-blinded study, the Investigators, the site staff, PellePharm, and the Clinical Monitor(s) will be blinded to the treatment assigned to individual subjects. Delegated staff members at the study site will dispense the investigational product (IP) and will collect and weigh all used and unused IP tubes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender.

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 7, 2019
• Study Start: December 20, 2019
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

US (14)