Melanoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

The subject must have completed PellePharm Study Pelle-926-201 or Pelle-926-301.
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.
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.
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.
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).
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.
The subject is willing for all facial BCCs to be evaluated and follow treatment recommendations made only by the Investigator.
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:

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

107

Study ID:

NCT04308395

Recruitment Status:

Terminated

Sponsor:

Sol-Gel Technologies, Ltd.

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There are 32 Locations for this study

See Locations Near You

PellePharm Investigative Site
Fremont California, 94538, United States
PellePharm Investigative Site
Newport Beach California, 92660, United States
Yale University
New Haven Connecticut, 06519, United States
Pellepharm Investigative Site
Miami Florida, 33125, United States
PellePharm Investigative Site
Ormond Beach Florida, 32174, United States
PellePharm Investigative Site
Chicago Illinois, 60637, United States
Laser & Skin Surgery Center of Indiana
Indianapolis Indiana, 46260, United States
Pellepharm Investigative Site
Ann Arbor Michigan, 48109, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Saint Louis University
Saint Louis Missouri, 63104, United States
Columbia University Irving Medical Center
New York New York, 10032, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Penn State Health Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Utah, Midvalley Dermatology
Murray Utah, 84107, United States
PellePhram Investigative Site
Leuven , 3000, Belgium
PellePharm Investigative Site
Copenhagen , DK-24, Denmark
PellePharm Investigative Site
Lille , , France
PellePharm Investigative Site
Nantes , 44093, France
Hopital Saint Louis
Paris , 75010, France
PellePharm Investigative Site
Berlin , 10117, Germany
PellePharm Investigative Site
Munich , 80337, Germany
PellePharm Investigative Site
Münster , 48149, Germany
AOU Luigi Vanvitelli
Napoli , 80131, Italy
PellePharm Investigative Site
Rozzano , 20089, Italy
PellePharm Investigative Site
Vicenza , 36100, Italy
PellePharm Investigative Site
Maastricht , 6229 , Netherlands
PellePharm Investigative Site
Barcelona , 08036, Spain
PellePharm Investigative Site
Madrid , 28023, Spain
PellePharm Investigative Site
Madrid , 28034, Spain
PellePharm Investigative Site
Sevilla , 41009, Spain
PellePharm Investigative Site
Glasgow , , United Kingdom
PellePharm Investigative Site
London , , United Kingdom
PellePharm Investigative Site
Manchester , , United Kingdom
PellePharm Investigative Site
Oxford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

107

Study ID:

NCT04308395

Recruitment Status:

Terminated

Sponsor:


Sol-Gel Technologies, Ltd.

How clear is this clinincal trial information?

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