13 completed, 3 terminated, 2 withdrawn, 1 active not recruiting. 20 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 20 | Completed 13, Terminated 3, Withdrawn 2, Active not recruiting 1, Suspended 1 |
| Phase 1 | 2 | Completed 1, Suspended 1 |
| Phase 3 | 1 | Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Coenzyme Q10 and Dentoalveolar Cyst Coenzyme Q10, control group - Cyst, Jaw | Phase 2 | Active not recruiting | Fayoum University | 20 | 2023-06-11 | 2025-03-03 |
| CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome PTX-022, Vehicle comparator - BCCs in Gorlin Syndrome Patients | Phase 2 | Completed | Palvella Therapeutics, Inc. | 73 | 2021-05-06 | 2024-08-29 |
| Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor ASN-002 - Basal Cell Carcinoma, Basal Cell Nevus Syndrome | Phase 2 | Completed | Ascend Biopharmaceuticals Ltd | 21 | 2020-07-16 | 2024-04-10 |
| A 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 Patidegib Topical Gel, 2%, Patidegib Topical Gel, Vehicle - Recurrent Basal Cell Carcinoma | Phase 2 | Terminated | Sol-Gel Technologies, Ltd. | 50 | 2019-12-20 | 2026-07-21 |
| Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome Vismodegib, Nivolumab, Ipilimumab - Basal Cell Nevus Syndrome | Phase 2 | Withdrawn | Columbia University | 2019-07-01 | 2019-12-18 | |
| Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndrome (BCNS) ASN-002 - Basal Cell Carcinoma in Basal Cell Nevus Syndrome | Phase 1 / Phase 2 | Suspended | Ascend Biopharmaceuticals Ltd | 24 | 2017-12-01 | 2023-02-06 |
| Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas Patidegib, Vehicle gel - Basal Cell Carcinomas | Phase 2 | Completed | PellePharm, Inc. | 36 | 2016-11-11 | 2019-01-08 |
| Trial of Patidegib Gel 2%, 4%, and Vehicle to Decrease the Number of Surgically Eligible Basal Cell Carcinomas in Gorlin Syndrome Patients Patidegib, Vehicle gel - Basal Cell Nevus Syndrome | Phase 2 | Completed | PellePharm, Inc. | 17 | 2016-06-06 | 2020-07-23 |
| A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors vismodegib - Keratocystic Odontogenic Tumor | Phase 2 | Completed | NYU College of Dentistry | 2 | 2015-10-27 | 2021-02-18 |
| A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma ASN-002, 5-FU - Basal Cell Nevus Syndrome, Skin Neoplasm | Phase 1 / Phase 2 | Completed | Ascend Biopharmaceuticals Ltd | 16 | 2015-09-01 | 2018-06-06 |
| Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma Buparlisib, Sonidegib - Carcinoma, Basal Cell, Recurrent Skin Cancer | Phase 2 | Terminated | Anne Chang | 10 | 2015-02-01 | 2019-01-29 |
| LDE225 for Patients With PTCH1 or SMO Mutated Tumors LDE225 - PTCH1 or SMO Activated Solid and Hematologic Tumors | Phase 2 | Terminated | Novartis Pharmaceuticals | 10 | 2014-02-01 | 2016-05-02 |
| Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed, Non-metastatic Desmoplastic Medulloblastoma Carboplatin, Cognitive Assessment, Cyclophosphamide - Desmoplastic/Nodular Medulloblastoma, Medulloblastoma | Phase 2 | Completed | Children's Oncology Group | 26 | 2013-12-24 | 2023-01-09 |
| Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas Vismodegib, Aminolevulinic acid %20 topical solution - Basal Cell Nevus Syndrome, Gorlin's Syndrome | Phase 2 | Completed | UCSF Benioff Children's Hospital Oakland | 24 | 2012-04-01 | 2020-11-02 |
| Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS) LDE225, Placebo - Basal Cell Carcinoma, Gorlin Syndrome | Phase 2 | Completed | Novartis Pharmaceuticals | 10 | 2011-04-01 | 2015-10-19 |
| To Determine The Efficacy and Safety of GDC-0449 in Patients With Basal Cell Nevus Syndrome (BCNS) GDC-0449 - Basal Cell Nevus Syndrome, Gorlin Syndrome | Phase 2 | Completed | UCSF Benioff Children's Hospital Oakland | 41 | 2009-08-01 | 2021-01-11 |
| A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients Vehicle, LDE225 0.25%, LDE225 0.75% - Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients | Phase 2 | Completed | Novartis Pharmaceuticals | 18 | 2009-07-01 | 2015-11-03 |
| Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Chest and Back tazarotene, placebo - Skin Carcinoma | Phase 2 | Completed | UCSF Benioff Children's Hospital Oakland | 34 | 2004-07-01 | 2016-02-11 |
| Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face tazarotene - Neoplastic Syndrome | Phase 2 | Completed | UCSF Benioff Children's Hospital Oakland | 36 | 2004-07-01 | 2020-10-29 |
| Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS) LDE225B, Vehicle - Basal Cell Carcinoma | Phase 2 / Phase 3 | Withdrawn | Novartis Pharmaceuticals | 2017-05-05 |
Basal Cell Nevus Syndrome (18) · Carcinoma, Basal Cell (13) · Skin Neoplasms (2) · Colonic Neoplasms (1) · Endometrial Neoplasms (1) · Hematologic Neoplasms (1) · Medulloblastoma (1) · Neoplasms (1) · Odontogenic Cysts (1) · Rombo syndrome (1) · Syndrome (1) · Xeroderma Pigmentosum (1)
Bone Cysts (20) · Cysts (20) · Jaw Diseases (20) · Musculoskeletal Diseases (20) · Stomatognathic Diseases (20) · Neoplasms (19) · Abnormalities, Multiple (18) · Bone Diseases (18) · Bone Diseases, Developmental (18) · Carcinoma (18) · Congenital Abnormalities (18) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (18) · Genetic Diseases, Inborn (18) · Neoplasms by Histologic Type (18)
HhAntag691 (4) · gusacitinib (3) · sonidegib (3) · Drug Evaluation (2) · IPI-926 (2) · tazarotene (2) · Aminolevulinic Acid (1) · Carboplatin (1) · Control Groups (1) · Cyclophosphamide (1) · Etoposide (1) · Fluorouracil (1) · Ipilimumab (1) · Mental Status and Dementia Tests (1) · Methotrexate (1)
Novartis Pharmaceuticals (4) · UCSF Benioff Children's Hospital Oakland (4) · Ascend Biopharmaceuticals Ltd (3) · PellePharm, Inc. (2) · Anne Chang (1) · Children's Oncology Group (1) · Columbia University (1) · Fayoum University (1) · NYU College of Dentistry (1) · Palvella Therapeutics, Inc. (1) · Sol-Gel Technologies, Ltd. (1)
United States (12) · Australia (3) · Canada (3) · United Kingdom (3) · Austria (2) · Belgium (2) · Germany (2) · Switzerland (2) · Czechia (1) · Egypt (1) · Finland (1) · Greece (1) · Italy (1) · Puerto Rico (1) · Spain (1)
Ervin Epstein, MD (5) · David R. Bickers, MD (2) · Gregory Siller (2) · Anna Bar (1) · Anne Lynn Chang, MD (1) · Brian L Schmidt, DDS, MD, PhD (1) · Clement Leong (1) · Clement Leong, Ph.D (1) · David Bickers, MD (1) · John Lear, MD (1) · Joyce Teng, MD (1) · Lucie E Lafay-Cousin (1) · Lynda Spelman (1) · Richard Carvajal, MD. (1)
PMID 22670904, PMID 24441673, PMID 24623282, PMID 27838224, PMID 29175429
R01CA109584 (2), 2015 (1), U10CA098543 (1), U10CA180886 (1), U19CA081888 (1)