Nintedanib

Generic Name: Nintedanib

Brand Names: Ofev, Vargatef, Nintedanib Accord

Drug Type: Small Molecule

Chemical Formula: C_₃₁H_₃₃N_₅O_₄

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 tw...

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.
...

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: -

Clinical Trials

Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent

Phase 2

Completed

Conditions: Recurrent Pleural Malignant Mesothelioma
Stage IV Pleural Mesothelioma

Interventions: Drug: Nintedanib

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

Phase 2

Completed

Conditions: Lung Cancer
Lung Metastases

Interventions: Drug: Prednisone
Drug: Nintedanib
Other: Placebo

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

and more 9 locations

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

Phase 2

Terminated

Conditions: Lung Non-Squamous Non-Small Cell Carcinoma
Radiation-Induced Pneumonitis
Stage II Lung Non-Small Cell Cancer AJCC v7
Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
Stage III Lung Non-Small Cell Cancer AJCC v7
Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions: Other: Placebo
Biological: Durvalumab
Procedure: Quality-of-Life Assessment
Drug: Nintedanib

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

Phase 2

Completed

Conditions: Carcinoid Tumor
Metastatic Carcinoid Tumor
Neuroendocrine Neoplasm

Interventions: Other: Laboratory Biomarker Analysis
Drug: Nintedanib
Other: Pharmacological Study
Other: Quality-of-Life Assessment

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

Phase 1

Completed

Conditions: Rectal Adenocarcinoma
Recurrent Colon Carcinoma
Recurrent Rectal Carcinoma
Stage IVA Rectal Cancer
Stage IVA Colon Cancer
Stage IVB Rectal Cancer
Colon Adenocarcinoma
Stage IVB Colon Cancer

Interventions: Drug: Capecitabine
Other: Laboratory Biomarker Analysis
Drug: Nintedanib
Other: Pharmacological Study

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

Phase 1

Completed

Conditions: Cutaneous Malignant Melanoma

Interventions: Drug: Nintedanib-Placebo
Drug: Nintedanib
Drug: Paclitaxel

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

and more 7 locations

Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

Phase 1

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Nintedanib
Drug: Docetaxel

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

and more 3 locations

Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Carcinoma, Non-Small-Cell Lung
Non-Small Cell Lung Cancer
Nonsmall Cell Lung Cancer

Interventions: Drug: Nintedanib

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

Phase 2

Completed

Conditions: Esophagogastric Adenocarcinoma

Interventions: Drug: Nintedanib

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

and more 3 locations

LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research

Phase 3

Terminated

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: docetaxel
Drug: placebo
Drug: nintedanib

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

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