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Vismodegib

Generic Name
Vismodegib
Brand Names
Erivedge
Drug Type
Small Molecule
Chemical Formula
C19H14Cl2N2O3S
CAS Number
879085-55-9
Unique Ingredient Identifier
25X868M3DS
Background

Vismodegib is an orally active small molecule that inhibits the hedgehog signaling pathway by binding to and inhibiting the transmembrane protein smoothened homologue (SMO). It was discovered by high-throughput screening of a library of small-molecule compounds and subsequent optimization through medicinal chemistry. Since it targets the hedgehog signaling pathway, vismodegib has anti-tumor activity in basal-cell carcinoma. The Hedgehog signaling pathway plays an important role in the development of organs and tissues during embryogenesis. Afterwards, it is silenced in all cells and tissues, except for hair, skin and stem cells. However, dysregulated or aberrant Hedgehog signaling has been associated with basal cell carcinoma pathogenesis. In January 2012, vismodegib was approved by the FDA for the treatment of adult basal cell carcinoma. In July 2013, it was approved by the EMA, and since then, it has been approved by several other countries.

Indication

用于不能手术或放疗的局部晚期皮肤基底细胞癌患者和肿瘤已转移的患者。

Associated Conditions
Locally Advanced Basal Cell Carcinoma, Metastatic Basal cell carcinoma

A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)

Completed
Conditions
Basal Cell Carcinoma
Interventions
First Posted Date
2015-02-26
Last Posted Date
2020-10-09
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
50
Registration Number
NCT02371967
Locations
🇸🇪

Skånes Universitetssjukhus; Hudkliniken, Lund, Sweden

🇸🇪

SU/Sahlgrenska, Hudkliniken, Göteborg, Sweden

🇸🇪

Norrlands universitetssjukhus; Onkologkliniken, Umeå, Sweden

and more 1 locations

A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors

Phase 2
Completed
Conditions
Keratocystic Odontogenic Tumor
Interventions
First Posted Date
2015-02-19
Last Posted Date
2021-02-18
Lead Sponsor
NYU College of Dentistry
Target Recruit Count
2
Registration Number
NCT02366312
Locations
🇺🇸

NYU Bluestone Center For Cllinical Research, New York, New York, United States

Vismodegib in Treating Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease

Phase 2
Terminated
Conditions
Chronic Graft Versus Host Disease
Interventions
Other: Laboratory Biomarker Analysis
First Posted Date
2015-01-13
Last Posted Date
2021-07-19
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
6
Registration Number
NCT02337517
Locations
🇺🇸

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

🇺🇸

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

A Study of Oral Vismodegib for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

Phase 2
Withdrawn
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
Drug: placebo
First Posted Date
2014-06-20
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Registration Number
NCT02168530

A Study of Vismodegib in Men With Metastatic CRPC With Accessible Metastatic Lesions for Tumor Biopsy

Early Phase 1
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2014-04-16
Last Posted Date
2018-07-20
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
9
Registration Number
NCT02115828
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

Phase 2
Completed
Conditions
Bladder Cancer
Neoplasms
Solid Tumors
Biliary Cancer
Salivary Cancer
Interventions
First Posted Date
2014-03-19
Last Posted Date
2024-07-23
Lead Sponsor
Genentech, Inc.
Target Recruit Count
673
Registration Number
NCT02091141
Locations
🇺🇸

University Of Chicago Medical Center; Section Of Hematology/Oncology, Chicago, Illinois, United States

🇺🇸

MD Anderson, Houston, Texas, United States

🇺🇸

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

and more 57 locations

Ribavirin and Hedgehog Inhibitor With or Without Decitabine in AML

Phase 2
Completed
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2014-02-27
Last Posted Date
2023-09-29
Lead Sponsor
Sarit Assouline
Target Recruit Count
23
Registration Number
NCT02073838
Locations
🇨🇦

Jewish General Hospital, Montreal, Quebec, Canada

Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention

Phase 2
Terminated
Conditions
Basal Cell Carcinomas
Interventions
Drug: Placebo
First Posted Date
2014-02-20
Last Posted Date
2019-08-14
Lead Sponsor
University of Arizona
Target Recruit Count
9
Registration Number
NCT02067104
Locations
🇺🇸

University of Arizona Cancer Center, Tucson, Arizona, United States

Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia

Phase 2
Terminated
Conditions
Diffuse Large B-cell Lymphoma
Indolent Non-hodgkin Lymphoma
Primary Central Nervous System Lymphoma
Chronic Lymphocytic Leukemia
Interventions
First Posted Date
2013-09-18
Last Posted Date
2017-03-13
Lead Sponsor
The Lymphoma Academic Research Organisation
Target Recruit Count
31
Registration Number
NCT01944943
Locations
🇫🇷

CHRU de Lille _ Hôpital Huriez, Lille, France

🇫🇷

CHU de Nantes _ Hôtel Dieu, Nantes, France

🇫🇷

Centre Henri Becquerel, Rouen, France

and more 7 locations

A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma

Phase 2
Terminated
Conditions
Basal Cell Carcinoma
Interventions
Drug: Placebo
First Posted Date
2013-07-12
Last Posted Date
2017-05-08
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
18
Registration Number
NCT01898598
Locations
🇺🇸

Loma Linda University Medical Center, Loma Linda, California, United States

🇺🇸

Mayo Clinic, Scottsdale, Arizona, United States

🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

and more 18 locations
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