Therapy Detail

Therapy Name Nintedanib
Therapy Description

Ofev (nintedanib) is a triple angiokinase inhibitor that acts by blocking VEGFR, FGFR, RET, and PDGFR, thereby preventing tumorigenesis (PMID: 24947258, PMID: 24561444). Ofev (nintedanib) is FDA approved for use in patients with idiopathic pulmonary fibrosis (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Nintedanib Ofev BIBF 1120|Vargatef FGFR Inhibitor (Pan) 17 PDGFR Inhibitor (Pan) 27 RET Inhibitor 36 VEGFR Inhibitor (Pan) 29 Ofev (nintedanib) is a triple angiokinase inhibitor that acts by blocking VEGFR, FGFR, RET, and PDGFR, thereby preventing tumorigenesis (PMID: 24947258, PMID: 24561444). Ofev (nintedanib) is FDA approved for use in patients with idiopathic pulmonary fibrosis (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown brain glioma not applicable Nintedanib Phase II Actionable In a Phase II clinical trial, Ofev (nintedanib) failed to show any efficacy in patients with recurrent high-grade glioma, regardless of prior bevacizumab therapy (PMID: 25338318). 25338318
FGFR2 N549K endometrial cancer resistant Nintedanib Preclinical Actionable In a preclinical study, Ofev (Nintedanib) did not inhibit growth of endometrial cancer cells harboring FGFR2 N549K in cell culture (PMID: 22238366). 22238366
Unknown unknown pancreatic endocrine carcinoma not applicable Nintedanib Preclinical Actionable In a preclinical study, Ofev (nintedanib) induced tumor cell apoptosis, decreased microvessel density, inhibited tumor growth, and improved survival in transgenic mouse models of pancreatic neuroendocrine carcinoma (PMID: 26206868). 26206868
FGFR2 act mut Advanced Solid Tumor decreased response Nintedanib Preclinical Actionable In a preclinical study, transformed cells expressing constitutively active FGFR2 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). 22238366
FGFR3 act mut Advanced Solid Tumor decreased response Nintedanib Preclinical Actionable In a preclinical study, transformed cells expressing constitutively active FGFR3 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). 22238366
Unknown unknown Advanced Solid Tumor not applicable Nintedanib Phase I Actionable In a Phase I trial, Ofev (nintedanib) demonstrated safety and some preliminary efficacy in patients with advanced solid tumors (PMID: 25795637). 25795637
FGFR2 amp colon cancer sensitive Nintedanib Preclinical Actionable In a preclinical study, Ofev (nintedanib) inhibited growth of colon cancer cells harboring FGFR2 amplification in culture (PMID: 22238366). 22238366
FGFR3 S249C urinary bladder cancer resistant Nintedanib Preclinical Actionable In a preclinical study, bladder cancer cells harboring FGFR3 S249C were resistant to Ofev (Nintedanib) induced inhibition of cell proliferation in culture (PMID: 22238366). 22238366
FGFR2 S252W endometrial cancer sensitive Nintedanib Preclinical Actionable In a preclinical study, Ofev (Nintedanib) inhibited cell proliferation in endometrial cancer cells harboring FGFR2 S252W mutation in culture (PMID: 22238366). 22238366
FGFR1 act mut Advanced Solid Tumor decreased response Nintedanib Preclinical Actionable In a preclinical study, transformed cells expressing constitutively active FGFR1 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). 22238366
Unknown unknown pancreatic cancer not applicable Nintedanib Preclinical - Cell line xenograft Actionable In a preclinical study, Nintedanib, alone or with chemotherapy, inhibited tumor growth in cell line xenograft models of lung and pancreatic cancer but not in cell culture (PMID: 23729403). 23729403
Unknown unknown Indication other than cancer not applicable Nintedanib FDA approved Actionable Ofev (nintedanib) is FDA approved for use in patients with idiopathic pulmonary fibrosis (FDA.gov). detail...
Unknown unknown ovarian cancer not applicable Nintedanib Phase I Actionable In a Phase I clinical trial, Vargatef (nintedanib) demonstrated safety in patients with ovarian cancers, clinical trials to determine efficacy in these patients are ongoing (PMID: 19889612). 19889612
Unknown unknown colorectal cancer not applicable Nintedanib Phase I Actionable In a Phase I trial, Ofev (nintedanib) demonstrated safety and efficacy in patients with advanced colorectal cancer (PMID: 25012508). 25012508
Unknown unknown lung cancer not applicable Nintedanib Preclinical - Cell line xenograft Actionable In a preclinical study, Nintedanib, alone or with chemotherapy, inhibited tumor growth in cell line xenograft models of lung and pancreatic cancer but not in cell culture (PMID: 23729403). 23729403
FGFR3 Y375C urinary bladder cancer resistant Nintedanib Preclinical Actionable In a preclinical study, bladder cancer cells harboring FGFR3 Y375C were resistant to growth inhibition by Ofev (Nintedanib) in culture (PMID: 22238366). 22238366
FGFR1 amp estrogen-receptor positive breast cancer sensitive Nintedanib Preclinical Actionable In a preclinical study, Ofev (nintedanib) inhibited the growth of ER-positive breast cancer cells harboring FGFR1 amplification in culture (PMID: 22238366). 22238366
Unknown unknown lung adenocarcinoma not applicable Nintedanib Phase III Actionable In a Phase III clinical trial, the combination of Ofev (nintedanib) and Taxotere (docetaxel) improved progression-free survival and overall survival in patients with lung adenocarcinoma compared to Taxotere (docetaxel) alone (PMID: 24411639). 24411639
Clinical Trial Phase Therapies Title Recruitment Status
NCT02452463 Phase II Nintedanib 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 Recruiting
NCT02231164 Phase III Docetaxel Nintedanib LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research Terminated
NCT02299141 Phase I Nintedanib Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer Recruiting
NCT02399215 Phase II Nintedanib Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors Active, not recruiting
NCT02665143 Phase Ib/II Cytarabine + Idarubicin Nintedanib A Randomized Trial of a Combination of Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First Relapse Acute Myeloid Leukemia Recruiting
NCT03287947 Phase II Nintedanib LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma Recruiting
NCT01907100 Phase III Cisplatin + Pemetrexed Nintedanib Nintedanib (BIBF 1120) in Mesothelioma Completed
NCT02149108 Phase III Nintedanib Nintedanib (BIBF 1120) vs Placebo in Refractory Colorectal Cancer Completed
NCT02902484 Phase Ib/II Nintedanib + Gemcitabine + nab-paclitaxel Nintedanib Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer Recruiting
NCT02234596 Phase II Nintedanib Nintedanib in Patients With Advanced Esophagogastric Cancer Active, not recruiting
NCT02152059 Phase II Nintedanib A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy Withdrawn
NCT02389764 Phase II Nintedanib Nintedanib For HER2-negative Metastatic Inflammatory Breast Cancer (MIBC) Terminated
NCT02568449 Phase II Nintedanib Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent Active, not recruiting
NCT01948141 Phase II Nintedanib Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens Completed
NCT02780700 Phase II Capecitabine + Nintedanib Nintedanib Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2] Terminated
NCT01669798 Phase II Nintedanib BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer Completed
NCT02496585 Phase II Nintedanib Prednisone Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis Recruiting