^
4d
An exploratory trial of the efficacy and safety of different nintedanib dosages for treating generalized keloids (ChiCTR2400089943)
P4, N=10, Not yet recruiting, Dematology Hospital of Southern Medical University; Dematology Hospital of Southern Medical University
New P4 trial
|
nintedanib
23d
NINSARC: RCT of Nintedanib in Fibrotic Sarcoidosis (clinicaltrials.gov)
P4, N=120, Recruiting, Post Graduate Institute of Medical Education and Research, Chandigarh | Active, not recruiting --> Recruiting
Enrollment open
|
nintedanib
23d
REPEAT: Real-life-persistence to Antifibrotic Treatments (clinicaltrials.gov)
P=N/A, N=800, Active, not recruiting, Boehringer Ingelheim | Not yet recruiting --> Active, not recruiting
Enrollment closed
|
nintedanib
24d
Platycodin D reduces PD-L1 levels by inhibiting LXR-β activity and combines with nintedanib to enhance the tumor-killing effect of T cells. (PubMed, FEBS Lett)
Coadministration of PD and nintedanib, known to upregulate MHC-I expression, enhanced tumor recognition and killing by T cells. This study provides new insights into PD applications and mechanisms.
Journal • PD(L)-1 Biomarker • IO biomarker
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PD-1 (Programmed cell death 1)
|
nintedanib
25d
New trial
|
nintedanib
29d
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan (clinicaltrials.gov)
P=N/A, N=425, Active, not recruiting, Boehringer Ingelheim | Trial primary completion date: Sep 2024 --> Dec 2024
Trial primary completion date
|
nintedanib
1m
NUCastle: Nintedanib Treatment in Unicentric Castleman Disease (clinicaltrials.gov)
P2, N=13, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
New P2 trial
|
nintedanib
1m
Fibroblast Growth Factor Receptor 1-Specific Dehydrogelation to Release Its Inhibitor for Enhanced Lung Tumor Therapy. (PubMed, ACS Nano)
Herein, a hydrogelator, Nap-Phe-Phe-Phe-Glu-Thr-Glu-Leu-Tyr-OH (Nap-Y), was rationally designed to coassemble with an FGFR1 inhibitor nintedanib (Nin) to form a peptide hydrogel Gel Y/Nin for localized administration and FGFR1-triggered release of Nin...Nude mouse studies show that Gel Y/Nin exhibits enhanced therapeutic efficacy on lung tumor than free Nin. We anticipate that Gel Y/Nin will be utilized for lung cancer treatment in clinical settings in the near future.
Journal
|
FGFR1 (Fibroblast growth factor receptor 1)
|
FGFR1 overexpression • FGFR1 expression
|
nintedanib
2ms
Cytokine priming enhances the antifibrotic effects of human adipose derived mesenchymal stromal cells conditioned medium. (PubMed, Stem Cell Res Ther)
In vitro, MSC-CM promote fibrosis resolution, an effect enhanced following MSC cytokine priming. Specifically, MSC-CM reduces fibrogenic myofibroblasts through apoptosis, senescence, and by enhancing ECM degradation. Future studies will establish the in vivo relevance of MSC priming to fibrosis resolution.
Journal • Stroma
|
IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • DKK1 (dickkopf WNT signaling pathway inhibitor 1) • TGFB1 (Transforming Growth Factor Beta 1) • CTSS (Cathepsin S) • MMP1 (Matrix metallopeptidase 1) • MMP3 (Matrix metallopeptidase 3)
|
nintedanib
2ms
High mechanical conditioning by tumor extracellular matrix stiffness is a predictive biomarker for anti-fibrotic therapy in HER2-negative breast cancer. (PubMed, Clin Cancer Res)
High MeCo is predictive of poor outcomes in HER2-negative early breast cancer, although this risk can be mitigated by nintedanib, which is able to specifically reduce mechanical conditioning.
Journal
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
paclitaxel • nintedanib
3ms
ENGOT-cx1/BGOG-cx1: 3 Weekly Carboplatin/Paclitaxel With or Without Nintedanib in Cervix Cancer (clinicaltrials.gov)
P2, N=120, Completed, Belgian Gynaecological Oncology Group | Active, not recruiting --> Completed
Trial completion • Metastases
|
carboplatin • paclitaxel • nintedanib
4ms
Self-Oxygenated Hydrogel Enhances Immune Cell Response and Infiltration Via Triggering Dual DNA Damage to Activate cGAS-STING and Inhibiting CAFs. (PubMed, Small)
A hydrogel drug-delivery platform, ALG@TBP-2/Pt(0)/nintedanib (ALG@TPN), is designed to induce strong immune functions and the dual elimination of the internal and external tumor microenvironment (TME)...Overall, the study provides a self-oxygenating hydrogel with the "PDT/chemotherapy/anti-CAFs" effect, triggering the cGAS/STING pathway to reshape the TME. Both internal and external interventions increase anti-TNBC immune responses.
Journal • Immune cell
|
STING (stimulator of interferon response cGAMP interactor 1) • CAT (Catalase)
|
nintedanib
4ms
Asymptomatic and slowly progressive anti-MDA5 ILD: A report of three cases deviating from a notoriously rapidly progressive ILD. (PubMed, Respir Med Case Rep)
She was treated with mycophenolate mofetil monotherapy for her skin manifestations...He was started on nintedanib...Given her lack of respiratory symptoms and normal PFTs, she was not initiated on ILD-specific treatment. While anti-MDA5 ILD is certainly associated with RP-ILD, clinicians should maintain awareness that there may be cases of asymptomatic or slowly progressive ILD as well.
Journal
|
IFIH1 (Interferon Induced With Helicase C Domain 1)
|
nintedanib
4ms
Enrollment closed • Enrollment change • HEOR • Real-world evidence • Real-world
|
nintedanib
4ms
Discovery and prospects of new heterocyclic Isatin-hydrazide derivative with a novel role as estrogen receptor α degrader in breast cancer cells. (PubMed, Front Chem)
Tamoxifen and fulvestrant represent standard therapy options in estrogen-mediated disease but have their own limitations. Isatin-based triple angiokinase inhibitor BIBF1120 (Nintedanib) and multikinase inhibitor Sunitinib (Sutent) have been approved by the FDA...Finally, molecular dynamics (MD) simulations indicated stable behavior of the protein-ligand complex between ERα and its ligand 5i. Overall, these results suggest that the new isatin derivative 5i holds promise as a new ERα degrader.
Journal
|
ER (Estrogen receptor)
|
sunitinib • tamoxifen • fulvestrant • nintedanib
4ms
Trial completion • HEOR • Real-world evidence • Real-world
|
nintedanib
4ms
A pilot study of nintedanib in molecularly selected patients with advanced non-small cell lung cancer. (PubMed, J Thorac Dis)
The most common adverse events of any grade included nausea (80%), fatigue (70%), diarrhea (60%), and anorexia (60%). In this pilot study in heavily pretreated and molecularly selected patients with metastatic NSCLC, nintedanib showed modest activity.
Journal • IO biomarker • Metastases
|
TP53 (Tumor protein P53) • FGFR1 (Fibroblast growth factor receptor 1) • FLT1 (Fms-related tyrosine kinase 1)
|
nintedanib
4ms
REPEAT: Real-life-persistence to Antifibrotic Treatments (clinicaltrials.gov)
P=N/A, N=800, Not yet recruiting, Boehringer Ingelheim
New trial
|
nintedanib
5ms
Advanced Delivery Strategies of Nintedanib for Lung Disorders and Beyond: A Comprehensive Review. (PubMed, AAPS PharmSciTech)
However, none of these delivery systems are commercialised, and further research is required to ensure safety and effectiveness in clinical settings. Yet, as research progresses, these advanced delivery systems promise to revolutionise the treatment landscape for various fibrotic disorders and cancers, potentially improving patient outcomes and quality of life.
Review • Journal • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
nintedanib
5ms
NINSARC: RCT of Nintedanib in Fibrotic Sarcoidosis (clinicaltrials.gov)
P4, N=120, Active, not recruiting, Post Graduate Institute of Medical Education and Research, Chandigarh
New P4 trial
|
nintedanib
5ms
STU 022016-083: Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=14, Terminated, University of Texas Southwestern Medical Center | Phase classification: P1b --> P1/2 | Active, not recruiting --> Terminated; The study was terminated due to futility and lack of future funding
Phase classification • Trial termination • Metastases
|
albumin-bound paclitaxel • nintedanib
6ms
Trial completion
|
nintedanib
6ms
Biomarkers associated with pulmonary exacerbations in a randomized trial of nintedanib for radiation pneumonitis. (PubMed, Radiother Oncol)
We identified a panel of serum biomarkers that showed association with nintedanib treatment and acute pulmonary exacerbations in patients with RP. A confirmatory study will be needed to validate this panel for use as a prognostic tool in patients with RP.
Clinical • Journal
|
TNFA (Tumor Necrosis Factor-Alpha) • CCL2 (Chemokine (C-C motif) ligand 2) • EGF (Epidermal growth factor) • TGFB1 (Transforming Growth Factor Beta 1) • IL5 (Interleukin 5)
|
nintedanib
6ms
Pazopanib attenuated bleomycin-induced pulmonary fibrosis via suppressing TGF-β1 signaling pathway. (PubMed, J Thorac Dis)
Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive interstitial lung disease with a high mortality rate and limited treatment efficacy. Pazopanib inhibits myofibroblast activation, migration, autophagy, apoptosis, and extracellular matrix (ECM) buildup by downregulating the TGF-β1/Smad signal route and the TGF-β1/non-Smad signal pathway. It has the same target as nintedanib and is a tyrosine kinase inhibitor.
Journal
|
TGFB1 (Transforming Growth Factor Beta 1)
|
pazopanib • nintedanib • bleomycin
6ms
Trial completion • Surgery
|
cisplatin • docetaxel • nintedanib
6ms
Enrollment open • Real-world evidence • Real-world
|
nintedanib
7ms
A phase I/II study of nintedanib and capecitabine for refractory metastatic colorectal cancer. (PubMed, JNCI Cancer Spectr)
The combination of nintedanib and capecitabine is well tolerated. Clinical efficacy appears to be superior to regorafenib or tipiracil hydrochloride monotherapy. Further investigation of similar combinations is warranted.
P1/2 data • Clinical Trial,Phase I • Clinical Trial,Phase II • Journal • Metastases
|
SPP1 (Secreted Phosphoprotein 1)
|
Avastin (bevacizumab) • capecitabine • Stivarga (regorafenib) • nintedanib
7ms
Reprogramming the pancreatic cancer stroma and immune landscape by a silicasome nanocarrier delivering nintedanib, a protein tyrosine kinase inhibitor. (PubMed, Nano Today)
In summary, our pioneering approach involving the silicasome carrier not only improved antitumor angiogenesis but also profoundly reshaped the desmoplastic stromal and immune landscape within PDAC. These insights hold excellent promise for the development of innovative combinatorial strategies in PDAC therapy.
Journal • Stroma
|
PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • FGFR (Fibroblast Growth Factor Receptor) • CD8 (cluster of differentiation 8) • FOXP3 (Forkhead Box P3)
|
nintedanib
7ms
Enrollment closed
|
nintedanib
7ms
Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis (clinicaltrials.gov)
P2, N=33, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Apr 2024 | Trial primary completion date: Jul 2025 --> Apr 2024
Trial completion • Trial completion date • Trial primary completion date
|
prednisone • nintedanib
7ms
Trial completion
|
nintedanib
8ms
Aberrant TIMP-1 production in tumor-associated fibroblasts drives the selective benefits of nintedanib in lung adenocarcinoma. (PubMed, Cancer Sci)
We further pinpoint reduced SMAD3 expression and consequent limited TIMP-1 production in SCC-TAFs as key for the resistance of SCC to nintedanib. These observations strongly support the emerging role of TIMP-1 as a critical regulator of therapy response in solid tumors.
Journal
|
TIMP1 (Tissue inhibitor of metalloproteinases 1) • SMAD3 (SMAD Family Member 3)
|
nintedanib
8ms
Glasgow prognostic score and body mass index predict short-term discontinuation of the antifibrotic agents pirfenidone and nintedanib. (PubMed, Respir Investig)
GPS and BMI were significant factors for short-term pirfenidone and nintedanib discontinuation, respectively. Initial evaluation of GPS and BMI prior to antifibrotic therapy may contribute to less interrupted IPF management, thus leading to better prognostic outcomes in patients with IPF.
Journal
|
CRP (C-reactive protein)
|
nintedanib
9ms
Proteomic study on nintedanib in gastric cancer cells. (PubMed, PeerJ)
Nintedanib inhibits the proliferation, invasion, and metastasis of gastric cancer cells. The crossover pathways and protein networks predicted by proteomics should provide more detailed molecular information enabling the use of nintedanib against gastric cancer.
Journal
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • ACOX1 (Acyl-CoA Oxidase 1)
|
nintedanib
9ms
NINBOST2018: Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (clinicaltrials.gov)
P2, N=20, Recruiting, University Hospital, Basel, Switzerland | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
Trial completion date • Trial primary completion date
|
nintedanib
9ms
Single‑agent nintedanib suppresses metastatic osteosarcoma growth by inhibiting tumor vascular formation. (PubMed, Oncol Lett)
In addition, nintedanib exhibited an anti-osteosarcoma effect on C57BL/6 severe combined immunodeficient mice in which T- and B-cell function is obsolete, suggesting that the antitumor effect of nintedanib was not attributable to antitumor immunity. Collectively, these findings indicated that nintedanib holds potential for treating osteosarcoma.
Journal • Metastases
|
FGFR (Fibroblast Growth Factor Receptor) • CD31 (Platelet and endothelial cell adhesion molecule 1) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
|
nintedanib
9ms
Trial completion
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • nintedanib
10ms
Inhibitor of PD-1/PD-L1: a new approach may be beneficial for the treatment of idiopathic pulmonary fibrosis. (PubMed, J Transl Med)
The use of the antifibrotic drugs pirfenidone and nintedanib can slow the progression of the disease to some extent, but it does not have a reverse effect on the prognosis. While current studies have focused on PD-1/PD-L1 and CTLA-4, PD-1/PD-L1 may be the only effective immune checkpoint IPF treatment. This review discusses the application of PD-1/PD-L1 checkpoint in IPF, with the aim of finding a new direction for IPF treatment.
Review • Journal
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
nintedanib
10ms
Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=20, Active, not recruiting, Washington University School of Medicine | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • FLT1 (Fms-related tyrosine kinase 1)
|
EGFR mutation • ALK rearrangement • RET rearrangement • FGFR1 fusion
|
nintedanib