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

Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas

Phase 2

Completed

Conditions: Basal Cell Nevus Syndrome
Gorlin's Syndrome

Interventions: Drug: Aminolevulinic acid %20 topical solution
Drug: Vismodegib

First Posted Date: 2012-03-16

Last Posted Date: 2020-11-02

Lead Sponsor: UCSF Benioff Children's Hospital Oakland

Target Recruit Count: 24

Registration Number: NCT01556009

Locations: 🇺🇸
Children's Hospital Oakland Research Institiute, Oakland, California, United States
🇺🇸
Children's Hospital Research Center Oakland, Oakland, California, United States
🇺🇸
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States

A Study of Vismodegib in Patients With Advanced Solid Malignancies Including Hepatocellular Carcinoma With Varying Degrees of Renal or Hepatic Function

Phase 1

Completed

Conditions: Cancer

Interventions: Drug: Vismodegib

First Posted Date: 2012-03-07

Last Posted Date: 2016-05-23

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 31

Registration Number: NCT01546519

Vismodegib for Treatment of Basal Cell Carcinoma

Phase 2

Completed

Conditions: Basal Cell Carcinoma

Interventions: Drug: Placebo
Drug: Vismodegib

First Posted Date: 2012-03-05

Last Posted Date: 2014-09-26

Lead Sponsor: Abel Torres, MD

Target Recruit Count: 3

Registration Number: NCT01543581

Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery

Phase 1

Completed

Conditions: Acinar Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Duct Cell Adenocarcinoma of the Pancreas
Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: vismodegib
Drug: sirolimus
Procedure: positron emission tomography
Procedure: computed tomography
Other: pharmacological study
Other: laboratory biomarker analysis
Radiation: fludeoxyglucose F 18

First Posted Date: 2012-02-23

Last Posted Date: 2019-04-08

Lead Sponsor: Mayo Clinic

Target Recruit Count: 31

Registration Number: NCT01537107

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Mayo Clinic Campus in Florida, Jacksonville, Florida, United States
🇺🇸
Mayo Clinic Campus in Arizona, Scottsdale, Arizona, United States

STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Phase 2

Completed

Conditions: Basal Cell Carcinoma

Interventions: Drug: vismodegib

First Posted Date: 2011-06-07

Last Posted Date: 2019-06-06

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1232

Registration Number: NCT01367665

Locations: 🇦🇺
Premier Specialists, Kogarah, New South Wales, Australia
🇦🇷
Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia, Buenos Aires, Argentina
🇦🇺
Skin and Cancer Foundation Australia, Westmead, New South Wales, Australia

and more 178 locations

Vismodegib After Stem Cell Transplant in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma

Phase 1

Completed

Conditions: DS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
Refractory Plasma Cell Myeloma

Interventions: Drug: Vismodegib
Other: Pharmacological Study
Other: Laboratory Biomarker Analysis

First Posted Date: 2011-04-06

Last Posted Date: 2014-12-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 50

Registration Number: NCT01330173

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Baltimore, Maryland, United States
🇺🇸
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

Vismodegib in Treating Patients With Advanced Chondrosarcomas

Phase 2

Active, not recruiting

Conditions: Clear Cell Chondrosarcoma
Dedifferentiated Chondrosarcoma
Mesenchymal Chondrosarcoma
Primary Central Chondrosarcoma
Unresectable Primary Central Chondrosarcoma
Locally Advanced Chondrosarcoma
Metastatic Chondrosarcoma

Interventions: Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Drug: Vismodegib

First Posted Date: 2010-12-29

Last Posted Date: 2025-01-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 45

Registration Number: NCT01267955

Locations: 🇫🇷
Centre Oscar Lambert, Lille, France
🇫🇷
Centre Leon Berard, Lyon, France
🇫🇷
Hopital De La Timone, Marseille, France

and more 3 locations

Vismodegib in Treating Younger Patients With Recurrent or Refractory Medulloblastoma

Phase 2

Completed

Conditions: Recurrent Childhood Medulloblastoma

Interventions: Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Vismodegib

First Posted Date: 2010-11-11

Last Posted Date: 2016-01-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT01239316

Locations: 🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
National Cancer Institute Pediatric Oncology Branch, Bethesda, Maryland, United States

and more 9 locations