Nintedanib
- Generic Name
- Nintedanib
- Brand Names
- Ofev, Vargatef, Nintedanib Accord
- Drug Type
- Small Molecule
- Chemical Formula
- C31H33N5O4
- CAS Number
- 656247-17-5
- Unique Ingredient Identifier
- G6HRD2P839
- Background
Nintedanib is a small molecule kinase inhibitor used in the treatment of pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and non-small cell lung cancer (NSCLC). It was first approved for use in the United States in 2014. Within the spectrum of idiopathic pulmonary fibrosis treatment options, nintedanib is currently one of only two disease-modifying therapies available and indicated for the condition (the other being Pirfenidone) and as such is used as a first-line treatment following diagnosis to slow down the progressive loss of lung function. As a chemotherapeutic agent for NSCLC, nintedanib, in combination with Docetaxel, is reserved for patients who have tried and failed first-line chemotherapeutic options.
- Indication
Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) and to slow declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease. It is also indicated for the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype.
In the EU, under the brand name Vargatef, nintedanib is indicated in combination with docetaxel for the treatment of adult patients with metastatic, locally advanced, or locally recurrent non-small cell lung cancer of adenocarcinoma histology who have already tried first-line therapy.
- Associated Conditions
- Idiopathic Pulmonary Fibrosis (IPF), Respiratory Function Impaired, Chronic Progressive Fibrosing Interstitial Lung Disease, Locally advanced Non-Small Cell Lung Carcinoma (NSCLC), Locally recurrent Non-Small Cell Lung Carcinoma (NSCLC), Metastatic Non-Small Cell Lung Carcinoma (NSCLC)
- Associated Therapies
- -
Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent
- Conditions
- Interventions
- First Posted Date
- 2015-10-05
- Last Posted Date
- 2021-12-09
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- Target Recruit Count
- 20
- Registration Number
- NCT02568449
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
- Conditions
- Interventions
- First Posted Date
- 2015-07-14
- Last Posted Date
- 2024-04-16
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 33
- Registration Number
- NCT02496585
- Locations
- 🇺🇸
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy
- Conditions
- Lung Non-Squamous Non-Small Cell CarcinomaRadiation-Induced PneumonitisStage II Lung Non-Small Cell Cancer AJCC v7Stage IIA Lung Non-Small Cell Carcinoma AJCC v7Stage IIB Lung Non-Small Cell Carcinoma AJCC v7Stage III Lung Non-Small Cell Cancer AJCC v7Stage IIIA Lung Non-Small Cell Cancer AJCC v7Stage IIIB Lung Non-Small Cell Cancer AJCC v7Stage IV Lung Non-Small Cell Cancer AJCC v7
- Interventions
- First Posted Date
- 2015-05-22
- Last Posted Date
- 2020-04-06
- Lead Sponsor
- Roswell Park Cancer Institute
- Target Recruit Count
- 8
- Registration Number
- NCT02452463
- Locations
- 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
- First Posted Date
- 2015-03-26
- Last Posted Date
- 2023-12-26
- Lead Sponsor
- Roswell Park Cancer Institute
- Target Recruit Count
- 32
- Registration Number
- NCT02399215
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸Roswell Park Cancer Institute, Buffalo, New York, United States
Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-03-19
- Last Posted Date
- 2021-07-08
- Lead Sponsor
- Roswell Park Cancer Institute
- Target Recruit Count
- 42
- Registration Number
- NCT02393755
- Locations
- 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸Roswell Park Cancer Institute, Buffalo, New York, United States
Efficacy and Safety of Nintedanib Combined With Paclitaxel Chemotherapy for Patients With BRAF wt Metastatic Melanoma
- Conditions
- Interventions
- First Posted Date
- 2014-12-04
- Last Posted Date
- 2020-10-14
- Lead Sponsor
- Prof. Dr. med. Dirk Schadendorf
- Target Recruit Count
- 33
- Registration Number
- NCT02308553
- Locations
- 🇩🇪
University Hospital Essen, Essen, NRW, Germany
🇩🇪Fachklinik Hornheide, Münster, Germany
🇩🇪Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen, Germany
Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
- Conditions
- Interventions
- First Posted Date
- 2014-11-25
- Last Posted Date
- 2018-11-01
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 10
- Registration Number
- NCT02300298
- Locations
- 🇯🇵
1199.90.81006 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan
🇯🇵1199.90.81001 Boehringer Ingelheim Investigational Site, Chiba , Kashiwa, Japan
🇯🇵1199.90.81003 Boehringer Ingelheim Investigational Site, Kanagawa, Yokohama, Japan
Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2014-11-24
- Last Posted Date
- 2024-03-13
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 20
- Registration Number
- NCT02299141
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
Nintedanib in Patients With Advanced Esophagogastric Cancer
- First Posted Date
- 2014-09-09
- Last Posted Date
- 2021-01-25
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 34
- Registration Number
- NCT02234596
- Locations
- 🇺🇸
Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States
🇺🇸Memorial Sloan Kettering Cancer Center 1275 York Avenue, New York, New York, United States
LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
- Conditions
- Interventions
- First Posted Date
- 2014-09-04
- Last Posted Date
- 2017-03-21
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 12
- Registration Number
- NCT02231164
- Locations
- 🇹🇭
Boehringer Ingelheim Investigational Site, Bangkok, Thailand
Drug Development Updates
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