Trial record 1 of 64 for: Basal Cell Carcinoma Recurrent

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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

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ClinicalTrials.gov Identifier: NCT04155190

Recruitment Status : Recruiting

First Posted : November 7, 2019

Last Update Posted : December 24, 2019

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

PellePharm, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Recurrent Basal Cell Carcinoma	Drug: Patidegib Topical Gel, 2% Drug: Patidegib Topical Gel, Vehicle	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	45 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender.
Masking:	Triple (Participant, Care Provider, Investigator)
Masking Description:	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.
Primary Purpose:	Treatment
Official Title:	A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 2 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Patients With Non-Gorlin High Frequency BCC
Actual Study Start Date :	December 20, 2019
Estimated Primary Completion Date :	June 30, 2020
Estimated Study Completion Date :	April 30, 2021

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Nevoid Basal Cell Carcinoma Syndrome Xeroderma Pigmentosum

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Patidegib Topical Gel, 2% Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months	Drug: Patidegib Topical Gel, 2% Patidegib Topical Gel, 2% Other Name: IP
Active Comparator: Patidegib Topical Gel, Vehicle Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months	Drug: Patidegib Topical Gel, Vehicle Patidegib Topical Gel, Vehicle Other Name: IP, Vehicle

Outcome Measures

Primary Outcome Measures :

Number of new surgically eligible BCCs (nSEBs) [ Time Frame: Baseline through Month 9 ]

Secondary Outcome Measures :

Number of treatment emergent adverse events assessed with means and standard errors or proportions [ Time Frame: Baseline through Month 9 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155190

Contacts

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Contact: Sr. Clinical Operations Manager	844-332-5161	clinical@pellepharm.com

Locations

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United States, California
PellePharm Investigative Site	Recruiting
Los Angeles, California, United States, 90045
Contact clinical@pellepharm.com
United States, Florida
PellePharm Investigative Site	Recruiting
Ormond Beach, Florida, United States, 32174
Contact clinical@pellepharm.com
PellePharm Investigative Site	Recruiting
Saint Augustine, Florida, United States, 32080
Contact clinical@pellepharm.com

Sponsors and Collaborators

PellePharm, Inc.

Investigators

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Study Director:	VP, Clinical Operations	PellePharm, Inc.

More Information

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Responsible Party:	PellePharm, Inc.
ClinicalTrials.gov Identifier:	NCT04155190
Other Study ID Numbers:	Pelle-926-203
First Posted:	November 7, 2019 Key Record Dates
Last Update Posted:	December 24, 2019
Last Verified:	December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by PellePharm, Inc.:


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

Additional relevant MeSH terms:

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Carcinoma Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type	Neoplasms Neoplasms, Basal Cell Veratrum Alkaloids Antihypertensive Agents

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