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.
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
| Drug | Synonyms | Arms |
|---|
| Patidegib Topical Gel, 2% | IP | Patidegib Topical Gel, 2% |
| Patidegib Topical Gel, Vehicle | IP, Vehicle | Patidegib 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
| Name | Type | Description | Interventions |
|---|
| Patidegib Topical Gel, 2% | Experimental | Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months | - 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 | - 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: | Terminated |
| 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
May 27, 2021
