Therapy Detail

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Therapy Name Nintedanib
Synonyms
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|BIBF 1120 FGFR Inhibitor (Pan) 19 PDGFR Inhibitor (Pan) 27 RET Inhibitor 41 VEGFR Inhibitor (Pan) 32 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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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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
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 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
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
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
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
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
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 Completed USA 0
NCT01907100 Phase III Cisplatin + Pemetrexed Disodium Nintedanib Nintedanib (BIBF 1120) in Mesothelioma Terminated USA | CAN 25
NCT02902484 Phase Ib/II Gemcitabine + Nab-paclitaxel + Nintedanib Nintedanib Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer Recruiting USA 0
NCT02231164 Phase III Docetaxel Nintedanib LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research Terminated USA 2
NCT02496585 Phase II Nintedanib Prednisone Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis Active, not recruiting USA 0
NCT02299141 Phase I Nintedanib Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer Active, not recruiting USA 0
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 USA 0
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 Terminated USA 0
NCT02399215 Phase II Nintedanib Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors Active, not recruiting USA 0
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 CAN 0
NCT02389764 Phase II Nintedanib Nintedanib For HER2-negative Metastatic Inflammatory Breast Cancer (MIBC) Terminated USA 0
NCT03287947 Phase II Nintedanib LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma Terminated USA 0
NCT02234596 Phase II Nintedanib Nintedanib in Patients With Advanced Esophagogastric Cancer Completed USA 0
NCT01669798 Phase II Nintedanib BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer Completed USA 0
NCT02780700 Phase II Capecitabine + Nintedanib Nintedanib Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2] Terminated USA 0
NCT02149108 Phase III Nintedanib Nintedanib (BIBF 1120) vs Placebo in Refractory Colorectal Cancer Completed USA | CAN 23
NCT02568449 Phase II Nintedanib Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent Completed USA 0
NCT02863055 Phase II Nintedanib Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma (NEMO) Unknown status 3


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