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

GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

Phase 2

Completed

Conditions: Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Adult Giant Cell Glioblastoma

Interventions: Drug: vismodegib
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2009-09-21

Last Posted Date: 2017-08-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 44

Registration Number: NCT00980343

Locations: 🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
University of California at Los Angeles, Los Angeles, California, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

and more 6 locations

A Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

Phase 1

Completed

Conditions: Solid Cancers

Interventions: Drug: GDC-0449

First Posted Date: 2009-08-31

Last Posted Date: 2017-07-11

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 67

Registration Number: NCT00968981

A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study

Phase 2

Completed

Conditions: Basal Cell Carcinoma
Metastatic Colorectal Cancer
Ovarian Cancer

Interventions: Drug: Vismodegib
Drug: FOLFOX
Drug: FOLFIRI
Drug: Bevacizumab

First Posted Date: 2009-08-14

Last Posted Date: 2015-01-07

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 19

Registration Number: NCT00959647

To Determine The Efficacy and Safety of GDC-0449 in Patients With Basal Cell Nevus Syndrome (BCNS)

Phase 2

Completed

Conditions: Basal Cell Nevus Syndrome
Gorlin Syndrome

Interventions: Drug: GDC-0449

First Posted Date: 2009-08-12

Last Posted Date: 2021-01-11

Lead Sponsor: UCSF Benioff Children's Hospital Oakland

Target Recruit Count: 41

Registration Number: NCT00957229

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

Vismodegib in Treating Patients With Recurrent or Refractory Medulloblastoma

Phase 2

Completed

Conditions: Adult Medulloblastoma

Interventions: Other: Pharmacological Study
Drug: Vismodegib

First Posted Date: 2009-07-15

Last Posted Date: 2016-02-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 31

Registration Number: NCT00939484

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
UCSF Medical Center-Mount Zion, San Francisco, California, United States

and more 10 locations

A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage

Phase 2

Completed

Conditions: Extensive Stage Small Cell Lung Carcinoma
Recurrent Small Cell Lung Carcinoma

Interventions: Drug: Cisplatin
Biological: Cixutumumab
Other: Laboratory Biomarker Analysis
Drug: Etoposide
Drug: Vismodegib

First Posted Date: 2009-04-23

Last Posted Date: 2021-01-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 168

Registration Number: NCT00887159

Locations: 🇺🇸
Boca Raton Regional Hospital, Boca Raton, Florida, United States
🇺🇸
Mason District Hospital, Havana, Illinois, United States
🇺🇸
Longmont United Hospital, Longmont, Colorado, United States

and more 297 locations

GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery

Phase 1

Active, not recruiting

Conditions: Adult Solid Neoplasm
Pancreatic Acinar Cell Carcinoma
Pancreatic Ductal Adenocarcinoma
Recurrent Pancreatic Carcinoma
Stage IV Pancreatic Cancer AJCC v6 and v7

Interventions: Other: Diagnostic Laboratory Biomarker Analysis
Drug: Erlotinib Hydrochloride
Drug: Gemcitabine Hydrochloride
Drug: Vismodegib

First Posted Date: 2009-04-08

Last Posted Date: 2025-03-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 55

Registration Number: NCT00878163

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Orlando Health Cancer Institute, Orlando, Florida, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

and more 1 locations

A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma

Phase 2

Completed

Conditions: Basal Cell Carcinoma

Interventions: Drug: Vismodegib 150 mg

First Posted Date: 2009-02-02

Last Posted Date: 2015-05-20

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 104

Registration Number: NCT00833417

GDC-0449 in Treating Young Patients With Medulloblastoma That is Recurrent or Did Not Respond to Previous Treatment

Phase 1

Completed

Conditions: Recurrent Childhood Medulloblastoma

Interventions: Drug: vismodegib
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2009-01-14

Last Posted Date: 2014-04-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 34

Registration Number: NCT00822458

Locations: 🇺🇸
UCSF-Mount Zion, San Francisco, California, United States
🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
🇺🇸
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States

and more 6 locations

A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission

Phase 2

Completed

Conditions: Ovarian Cancer

Interventions: Drug: Vismodegib 150 mg
Drug: Placebo to vismodegib

First Posted Date: 2008-08-22

Last Posted Date: 2017-06-08

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 104

Registration Number: NCT00739661

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