Basal Cell Nevus Syndrome Clinical Trial
Official title:
A Phase II Randomized, Open Label Trial Comparing the Effects of Intermittent Vismodegib Versus PDT on the Maintenance of Benefit Following 7 Months of Continuous Vismodegib Treatment in Patients With Multiple Basal Cell Carcinomas
The purpose of this study is to evaluate and compare the safety and efficacy of intermittent vismodegib and of Photodynamic Therapy (PDT).
This is a Phase II, 28 month, randomized, two arm multicenter clinical study design. During the initial 7 months of the study, all 24 subjects will receive vismodegib, 150mg/day. They then will be randomized in a 1:1 ratio to receive intermittent vismodegib, 150 mg/day, during months 10-13, 16-19, and 22-25 or to receive treatment with PDT at month 10 and at three month intervals thereafter. The safety and efficacy of intermittent vismodegib and of PDT will be assessed at the time of the subjects' visits to the Study Center and at the time of telephone contacts. A Data Safety Monitoring Board (DSMB) will review results for an interim analysis when 12 subjects have completed 28 months. The DSMB review will focus on adverse events and efficacy results. Subjects will be monitored for the presence of surrogate endpoint biomarkers (SEBs) at each Study visit. ;
| 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| Withdrawn |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 |
NCT00957229 -
To Determine The Efficacy and Safety of GDC-0449 in Patients With Basal Cell Nevus Syndrome (BCNS)
|
Phase 2 |