Basal Cell Nevus Syndrome Clinical Trial
Official title:
A Randomized, Phase II Multicenter Trial Evaluating the Efficacy and Safety of a Systemic Hedgehog Pathway Antagonist (GDC-0449) in Patients With Basal Cell Nevus Syndrome (BCNS)
The purpose of this study is to reduce the number of new surgically eligible BCCs by 50% appearing during month 3-18 of medication ingestion.
This is a Phase II, 18 month, double blind, randomized placebo-controlled, two arm multicenter clinical study design. During the 18-month treatment period, the safety and chemopreventive efficacy of 150 mg/day GDC-0449 versus placebo will be assessed, and include evaluations of the skin at monthly intervals for the first three months and then every 3 months for the next 15 months. Removal of new surgically eligible BCCs (SEBs) will be done by primary skin care physicians (PSCPs) or at Study Centers. A Data Safety Monitoring Board (DSMB) will review unblinded results for an interim analysis when 20 subjects have completed 12 months of drug. This review will focus on adverse events and efficacy results. Subjects will be monitored for the development of new SEBs after they discontinue study treatment. At the end of the 18 months, given that the observed adverse events are minimal, patients on placebo will be offered the opportunity to take GDC-0449 for 18 months in an open label continuation, followed by six months observation, and patients on GDC449 will be monitored for the next 24 months for assessment of the duration of benefit after stopping the drug. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02550678 -
A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00555633 -
Use of an SPF30 Sunscreen and an After-sun-lotion in Skin Cancer Risk Patients
|
N/A | |
| Recruiting |
NCT03483441 -
Vitamin D and Photodynamic Therapy for Treatment of BCC in BCNS
|
Phase 1 | |
| Active, not recruiting |
NCT03467789 -
Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma
|
Phase 1 | |
| Recruiting |
NCT05463757 -
Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study
|
||
| Completed |
NCT02762084 -
Trial of Patidegib Gel 2%, 4%, and Vehicle to Decrease the Number of Surgically Eligible Basal Cell Carcinomas in Gorlin Syndrome Patients
|
Phase 2 | |
| Terminated |
NCT04308395 -
Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)
|
Phase 3 | |
| Withdrawn |
NCT03767439 -
Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome
|
Phase 2 | |
| Completed |
NCT04416516 -
Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor
|
Phase 2 | |
| Recruiting |
NCT06330350 -
Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling
|
||
| Enrolling by invitation |
NCT06330324 -
Reproductive Options in Inherited Skin Diseases
|
||
| Terminated |
NCT02303041 -
Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT02100371 -
Study of BMS-833923 in Two Specific Patients With Basal Cell Nevus Syndrome
|
N/A | |
| Completed |
NCT03703310 -
Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)
|
Phase 3 | |
| Completed |
NCT02157623 -
Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome
|
N/A | |
| Completed |
NCT01556009 -
Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas
|
Phase 2 |