Clinical Trials /

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

Description:

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.

Related Conditions:
  • Basal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: Pelle-926-203
  • NCT ID: NCT04155190

Conditions

  • Recurrent Basal Cell Carcinoma

Interventions

DrugSynonymsArms
Patidegib Topical Gel, 2%IPPatidegib Topical Gel, 2%
Patidegib Topical Gel, VehicleIP, VehiclePatidegib Topical Gel, Vehicle

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Patidegib Topical Gel, 2%ExperimentalParticipants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months
  • Patidegib Topical Gel, 2%
Patidegib Topical Gel, VehicleActive ComparatorParticipants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months
  • Patidegib Topical Gel, Vehicle

Eligibility Criteria

        Inclusion Criteria:

          1. 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).

          2. 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:

          1. The subject has been previously diagnosed with Gorlin syndrome

          2. On medical history, family history or clinical examination there is a suspicion that
             the patient has Gorlin syndrome.

          3. Patients with a family history of medulloblastoma

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

          5. The subject has uncontrolled systemic disease.

          6. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of new surgically eligible BCCs (nSEBs)
Time Frame:Baseline through Month 9
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of treatment emergent adverse events assessed with means and standard errors or proportions
Time Frame:Baseline through Month 9
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:PellePharm, Inc.

Trial 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

Last Updated

April 20, 2020