Vismodegib

Generic Name: Vismodegib

Brand Names: Erivedge

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₁₄Cl_₂N_₂O_₃S

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

Clinical Trials

A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome

Phase 2

Terminated

Conditions: Myelodysplastic Syndromes, Myelogenous Leukemia, Acute

Interventions: Drug: cytarabine
Drug: vismodegib

First Posted Date: 2013-06-19

Last Posted Date: 2015-12-15

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 38

Registration Number: NCT01880437

A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

Phase 2

Active, not recruiting

Conditions: Medulloblastoma

Interventions: Radiation: Craniospinal Irradiation with boost to the primary tumor site
Drug: Cyclophosphamide
Drug: Cisplatin
Drug: Vincristine
Other: Aerobic Training
Drug: Vismodegib
Drug: Pemetrexed
Other: Neurocognitive Remediation
Drug: Gemcitabine

First Posted Date: 2013-06-17

Last Posted Date: 2025-05-02

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 660

Registration Number: NCT01878617

Locations: 🇺🇸
Rady Children's Hospital, San Diego, California, United States
🇺🇸
Texas Children's Cancer Center, Houston, Texas, United States
🇺🇸
Children's Hospital and Clinics of Minnesota, Minneapolis, Minnesota, United States

and more 20 locations

Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma

Phase 2

Completed

Conditions: Cutaneous Malignancy
Locally Advanced Basal Cell Carcinoma
Skin Cancer

Interventions: Drug: Vismodegib
Radiation: Radiation therapy

First Posted Date: 2013-04-19

Last Posted Date: 2021-05-03

Lead Sponsor: Sue Yom

Target Recruit Count: 24

Registration Number: NCT01835626

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

Phase 2

Completed

Conditions: Basal Cell Carcinoma

Interventions: Drug: Vismodegib
Drug: Placebo

First Posted Date: 2013-03-21

Last Posted Date: 2017-09-28

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 229

Registration Number: NCT01815840

Locations: 🇺🇸
Skin and Cancer Associates and the Center for Cosmetic Enhancement, Plantation, Florida, United States
🇺🇸
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
🇨🇦
Dermetics, Burlington, Ontario, Canada

and more 55 locations

Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma

Phase 2

Terminated

Conditions: Pontine Glioma

Interventions: Drug: Vismodegib

First Posted Date: 2013-01-23

Last Posted Date: 2024-08-06

Lead Sponsor: Giselle Sholler

Target Recruit Count: 9

Registration Number: NCT01774253

Locations: 🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States

A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: fluconazole
Drug: rabeprazole
Drug: itraconazole
Drug: vismodegib

First Posted Date: 2013-01-21

Last Posted Date: 2016-11-02

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 92

Registration Number: NCT01772290

Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Vismodegib Before Surgery in Pancreatic Cancer

Early Phase 1

Conditions: Pancreatic Adenocarcinoma Resectable

Interventions: Drug: gemcitabine
Drug: Vismodegib
Procedure: Neoadjuvant chemotherapy

First Posted Date: 2012-10-24

Last Posted Date: 2012-10-24

Lead Sponsor: Jean-Luc Van Laethem

Target Recruit Count: 21

Registration Number: NCT01713218

Locations: 🇧🇪
Erasme University Hospital (ULB), Brussels, Belgium
🇧🇪
Antwerp University Hospital (UZA), Edegem, Antwerpen, Belgium

Study Evaluating the Efficacy of Oral Vismodegib in Various Histologic Subtypes

Phase 2

Completed

Conditions: Basal Cell Carcinoma

Interventions: Drug: vismodegib (150 mg PO daily)

First Posted Date: 2012-10-04

Last Posted Date: 2019-05-23

Lead Sponsor: Mayo Clinic

Target Recruit Count: 28

Registration Number: NCT01700049

Locations: 🇺🇸
Saint Louis University Department of Dermatology, Saint Louis, Missouri, United States

Vismodegib in Treating Patients With Basal Cell Carcinoma (BCC)

Early Phase 1

Completed

Conditions: Basal Cell Carcinoma of the Skin
Recurrent Skin Cancer

Interventions: Drug: vismodegib
Procedure: Mohs surgery

First Posted Date: 2012-06-29

Last Posted Date: 2017-12-08

Lead Sponsor: Stanford University

Target Recruit Count: 15

Registration Number: NCT01631331

Locations: 🇺🇸
Stanford University, Stanford, California, United States

Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway

Phase 1

Terminated

Conditions: Activation of the Sonic Hedgehog (SHH) Pathway
Histologically Confirmed Medulloblastoma

Interventions: Drug: Temozolomide
Drug: vismodegib

First Posted Date: 2012-05-17

Last Posted Date: 2019-05-21

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 24

Registration Number: NCT01601184

Locations: 🇫🇷
Institut de Cancérologie de l'Ouest - René Gauducheau, St Herblain, Loire Atlantique, France
🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
Institut Claudius Régaud (iuct-oncopole), Toulouse, Haute-Garonne, France

and more 12 locations

Drug Development Updates

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