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

Vismodegib and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer

Phase 2

Completed

Conditions: Recurrent Pancreatic Carcinoma
Stage IV Pancreatic Cancer

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

First Posted Date: 2010-09-06

Last Posted Date: 2017-08-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 25

Registration Number: NCT01195415

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Evaluation of Food Effect on Pharmacokinetics of Vismodegib

Phase 1

Completed

Conditions: Malignant Neoplasm

Interventions: Other: Pharmacological Study
Drug: Vismodegib

First Posted Date: 2010-08-03

Last Posted Date: 2017-05-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 63

Registration Number: NCT01174264

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

A Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: moxifloxacin
Drug: GDC-0449
Drug: placebo

First Posted Date: 2010-08-02

Last Posted Date: 2017-02-17

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 61

Registration Number: NCT01173536

Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer

Phase 1

Terminated

Conditions: Stage IIB Prostate Cancer AJCC v7
Prostate Adenocarcinoma
Stage IIA Prostate Cancer AJCC v7

Interventions: Drug: Goserelin Acetate
Drug: Leuprolide Acetate
Other: Laboratory Biomarker Analysis
Drug: Vismodegib

First Posted Date: 2010-07-15

Last Posted Date: 2019-02-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 10

Registration Number: NCT01163084

Locations: 🇺🇸
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

and more 2 locations

A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Conditions: Basal Cell Carcinoma

First Posted Date: 2010-07-12

Last Posted Date: 2015-08-06

Lead Sponsor: Genentech, Inc.

Registration Number: NCT01160250

Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma

Phase 1

Completed

Conditions: Adult Epithelioid Hemangioendothelioma
Adult Angiosarcoma
Adult Epithelioid Sarcoma
Adult Extraskeletal Myxoid Chondrosarcoma
Adult Alveolar Soft Part Sarcoma
Adult Extraskeletal Osteosarcoma
Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Desmoplastic Small Round Cell Tumor

Interventions: Drug: Gamma-Secretase Inhibitor RO4929097
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Vismodegib

First Posted Date: 2010-06-30

Last Posted Date: 2018-08-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 78

Registration Number: NCT01154452

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Hedgehog Inhibition for Pancreatic Ductal Adenocarcinoma (PDAC) in the Preoperative Setting (HIPPoS)

Phase 2

Terminated

Conditions: Pancreatic Ductal Adenocarcinoma

Interventions: Drug: GDC-0449

First Posted Date: 2010-03-31

Last Posted Date: 2014-01-08

Lead Sponsor: Lisa Bax

Target Recruit Count: 3

Registration Number: NCT01096732

Locations: 🇬🇧
Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery

Phase 1

Terminated

Conditions: Progesterone Receptor Negative
Recurrent Breast Carcinoma
Estrogen Receptor Negative
Stage IIIB Breast Cancer
HER2/Neu Negative
Triple-Negative Breast Carcinoma
Stage IIIC Breast Cancer
Stage IV Breast Cancer

Interventions: Drug: Gamma-Secretase Inhibitor RO4929097
Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Other: Pharmacological Study
Drug: Vismodegib

First Posted Date: 2010-02-19

Last Posted Date: 2015-04-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 13

Registration Number: NCT01071564

Locations: 🇺🇸
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸
University of Michigan University Hospital, Ann Arbor, Michigan, United States
🇺🇸
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Adenocarcinoma
Recurrent Pancreatic Carcinoma
Stage IV Pancreatic Cancer AJCC v6 and v7

Interventions: Drug: Gemcitabine Hydrochloride
Other: Hydrocortisone/Placebo
Drug: Vismodegib

First Posted Date: 2010-02-08

Last Posted Date: 2024-11-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 118

Registration Number: NCT01064622

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

and more 22 locations

Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer

Phase 2

Completed

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Adenocarcinoma of the Stomach
Recurrent Gastric Cancer
Stage IV Gastric Cancer
Stage IIIA Gastric Cancer
Stage IIIB Gastric Cancer
Stage IIIC Gastric Cancer

Interventions: Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Other: placebo
Drug: vismodegib
Other: laboratory biomarker analysis

First Posted Date: 2009-09-23

Last Posted Date: 2016-01-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 124

Registration Number: NCT00982592

Locations: 🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
🇺🇸
Decatur Memorial Hospital, Decatur, Illinois, United States
🇺🇸
New York Cancer Consortium, Bronx;, New York, United States

and more 27 locations

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