Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)

Basal Cell Nevus Syndrome Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04308395
• Other study ID #: Pelle-926-301E
• Status: Terminated
• Phase: Phase 3
• Start date: June 3, 2020
• Est. completion date: July 14, 2021

Study information

• Verified date: May 2023
• Source: Sol-Gel Technologies, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: July 14, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subject must have completed PellePharm Study Pelle-926-201 or Pelle-926-301.

2. Study Pelle-926-301 subjects must have completed the End of Treatment Visit in Study 301, prior to the Screening Visit in this study. They must also complete all Study 301 related procedures prior to the Baseline Visit of this study.

3. 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. Moisturizers and emollients are allowed. Subjects will be encouraged to use their preferred sunscreen with a sunscreen protection factor (SPF) of at least 30 daily on all exposed skin sites.

4. Female subjects must have a negative pregnancy test. For Study 301 subjects a negative serum pregnancy test result from Study 301 is acceptable if the test was done within 7 days of the Screening Visit of this study.

5. If the subject is a woman of child bearing potential (WOCBP), she must be willing to use birth control methods which may be considered highly effective. Hormonal contraception must be supplemented with a barrier method (preferably condom). Birth control must start prior to Baseline, continue through the duration of the study, and for 30 days after last application of investigational product (IP).

6. If the subject is a male with a female sex partner who is a WOCBP, the subject must be willing to use condoms, even after a vasectomy, starting prior to Baseline, through the duration of the study, and for at least 3 months after the last application of IP.

7. The subject is willing for all facial BCCs to be evaluated and follow treatment recommendations made only by the Investigator.

8. The subject is willing to forego treatment of facial BCCs with anything other than the study IP except when the Investigator believes that delay of treatment of a BCC potentially might compromise the health of the subject. In such instances, the only other allowed form of treatment is surgical.

Exclusion Criteria:

1. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.

2. The subject has current, recent (within five half lives of the experimental drug or if half life not known, within the past 6 months prior to the Screening Visit), or planned (while enrolled in this study) participation in an experimental drug study (excluding Study 301).

3. The subject is a WOCBP who is unwilling or unable to comply with pregnancy prevention measures.

4. The subject is pregnant or breastfeeding.

Related Conditions & MeSH terms

• Basal Cell Nevus Syndrome
• Nevus
• Nevus, Pigmented
• Syndrome

Intervention

Drug:
• Patidegib Topical Gel, 2%
Patidegib Topical Gel, 2%

Locations

Country	Name	City	State
Belgium	PellePhram Investigative Site	Leuven
Denmark	PellePharm Investigative Site	Copenhagen
France	PellePharm Investigative Site	Lille
France	PellePharm Investigative Site	Nantes
France	Hopital Saint Louis	Paris
Germany	PellePharm Investigative Site	Berlin
Germany	PellePharm Investigative Site	Munich
Germany	PellePharm Investigative Site	Münster
Italy	AOU Luigi Vanvitelli	Napoli
Italy	PellePharm Investigative Site	Rozzano
Italy	PellePharm Investigative Site	Vicenza
Netherlands	PellePharm Investigative Site	Maastricht
Spain	PellePharm Investigative Site	Barcelona
Spain	PellePharm Investigative Site	Madrid
Spain	PellePharm Investigative Site	Madrid
Spain	PellePharm Investigative Site	Sevilla
United Kingdom	PellePharm Investigative Site	Glasgow
United Kingdom	PellePharm Investigative Site	London
United Kingdom	PellePharm Investigative Site	Manchester
United Kingdom	PellePharm Investigative Site	Oxford
United States	Pellepharm Investigative Site	Ann Arbor	Michigan
United States	PellePharm Investigative Site	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	PellePharm Investigative Site	Fremont	California
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	MD Anderson Cancer Center	Houston	Texas
United States	Laser & Skin Surgery Center of Indiana	Indianapolis	Indiana
United States	Pellepharm Investigative Site	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Utah, Midvalley Dermatology	Murray	Utah
United States	Yale University	New Haven	Connecticut
United States	Columbia University Irving Medical Center	New York	New York
United States	PellePharm Investigative Site	Newport Beach	California
United States	PellePharm Investigative Site	Ormond Beach	Florida
United States	Oregon Health and Science University	Portland	Oregon
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Sol-Gel Technologies, Ltd.

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)		12 months
Secondary	Change in number of facial BCCs removed by surgery		12 months
Secondary	Change in number of new lesions suspicious for BCC		12 months
Secondary	Change in Advanced Basal Cell Carcinoma Index (aBCCdex) lesion score		12 months
Secondary	Change in Dermatology Life Quality Index (DLQI)		12 months
Secondary	Change in EuroQol Group 5-level EQ 5D (EQ 5D 5L)		12 months