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Clinical trials for nintedanib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    66 result(s) found for: nintedanib. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2020-005554-23 Sponsor Protocol Number: 1199-0378 Start Date*: 2021-11-24
    Sponsor Name:Boehringer Ingelheim RCV GmbH & Co KG
    Full Title: An open-label trial of the long-term safety and tolerability of nintedanib per os, on top of standard of care, over at least 2 years, in children and adolescents with clinically significant fibrosi...
    Medical condition: Interstitial Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10066393 Respiratory bronchiolitis-associated interstitial lung disease LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Ongoing) ES (Ongoing) PL (Ongoing) HU (Ongoing) BE (Ongoing) NL (Ongoing) GR (Ongoing) DE (Completed) PT (Ongoing) FI (Completed) DK (Ongoing) IT (Ongoing) NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004530-14 Sponsor Protocol Number: 1199-0337 Start Date*: 2019-10-15
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: A double blind, randomised, placebo-controlled trial to evaluate the dose-exposure and safety of nintedanib per os on top of standard of care for 24 weeks, followed by open label treatment with nin...
    Medical condition: Interstitial Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10066393 Respiratory bronchiolitis-associated interstitial lung disease LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) PT (Completed) FI (Completed) NO (Completed) DK (Completed) FR (Completed) CZ (Completed) PL (Completed) GR (Completed) HU (Ongoing) GB (GB - no longer in EU/EEA) DE (Completed) BE (Ongoing) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-000525-32 Sponsor Protocol Number: 1199-0248 Start Date*: 2019-01-31
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: An open-label extension trial of the long term safety of nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
    Medical condition: Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10066393 Respiratory bronchiolitis-associated interstitial lung disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-002114-40 Sponsor Protocol Number: APHP200527 Start Date*: 2020-07-30
    Sponsor Name:Assistance Publique - Hôpitaux de Paris
    Full Title: Nintedanib for the treatment of SARS-Cov-2 induced pulmonary fibrosis
    Medical condition: Patients 2 to 6 months after Covid-19 acute pneumonia
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003891-22 Sponsor Protocol Number: BIO_LUME_1 Start Date*: 2015-10-06
    Sponsor Name:Medical University Innsbruck
    Full Title: Nintedanib (BIBF 1120) plus docetaxel in NSCLC patients progressing after first-line CTX: angiogenic biomarker identification, phase II trial
    Medical condition: The project aims for screening for potential biomarkers and biomarker combinations relevant for second line setting in NSCLC during combinational therapy with docetaxel and nintedanib. The predicit...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-000392-28 Sponsor Protocol Number: 1199.214 Start Date*: 2015-11-02
    Sponsor Name:Boehringer Ingelheim bv
    Full Title: A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lu...
    Medical condition: Patients with Systemic Sclerosis and associated Interstitial Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004859 10012977 Diffuse systemic sclerosis LLT
    19.1 100000004859 10036814 Progressive systemic sclerosis LLT
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10042954 Systemic sclerosis pulmonary PT
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10025109 Lung involvement in systemic sclerosis LLT
    19.1 100000004859 10042953 Systemic sclerosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) GB (Completed) PT (Completed) DK (Completed) BE (Completed) ES (Completed) GR (Completed) FR (Completed) PL (Completed) IE (Completed) FI (Completed) NO (Completed) SE (Completed) AT (Completed) HU (Prematurely Ended) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-005201-48 Sponsor Protocol Number: 1199.93 Start Date*: 2013-07-16
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: LUME-Meso: Double blind, randomised, multicentre, phase II/III study of nintedanib in combination with pemetrexed / cisplatin followed by continuing nintedanib monotherapy versus placebo in combina...
    Medical condition: Unresectable Malignant Pleural Mesothelioma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059518 Pleural mesothelioma malignant PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Prematurely Ended) GB (Completed) FR (Completed) DK (Completed) ES (Prematurely Ended) BE (Completed) NL (Prematurely Ended) SE (Completed) PT (Completed) CZ (Completed) AT (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2015-003360-37 Sponsor Protocol Number: 1199.247 Start Date*: 2017-02-28
    Sponsor Name:Boehringer Ingelheim
    Full Title: A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
    Medical condition: The aim of the current study is to investigate the efficacy and safety of 150 mg bid nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as pa...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Completed) BE (Completed) DE (Completed) GB (Completed) PL (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-000521-38 Sponsor Protocol Number: EORTC-08112 Start Date*: 2017-06-30
    Sponsor Name:European Organisation for Research and Treatment of Cancer
    Full Title: Nintedanib as maintenance treatment of malignant pleural mesothelioma (NEMO): a double-blind randomized phase II study of the EORTC Lung Cancer Group
    Medical condition: Malignant pleural mesothelioma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10035606 Pleural mesothelioma malignant localised LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (GB - no longer in EU/EEA) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-000095-42 Sponsor Protocol Number: 1199.52 Start Date*: 2014-10-08
    Sponsor Name:SCS Boehringer Ingelheim Comm.V
    Full Title: A double-blind, randomised, placebo controlled Phase III study of nintedanib plus best supportive care (BSC) versus placebo plus BSC in patients with colorectal cancer refractory to standard therap...
    Medical condition: Patients with metastatic colorectal cancer refractory to standards therapies
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LU (Completed) IT (Completed) SE (Completed) AT (Completed) DK (Completed) BE (Completed) DE (Completed) PT (Completed) NL (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-002109-73 Sponsor Protocol Number: NiCCC2013 Start Date*: 2013-11-14
    Sponsor Name:Greater Glasgow Health Board
    Full Title: A Randomised Phase II Study of Nintedanib (BIBF1120) Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium
    Medical condition: Recurrent clear cell carcinoma of the ovary or endometrium
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009252 Clear cell endometrial carcinoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed) FR (Completed) NL (Completed) DK (Prematurely Ended) FI (Prematurely Ended) NO (Completed)
    Trial results: View results
    EudraCT Number: 2016-003403-66 Sponsor Protocol Number: 1199.225 Start Date*: 2017-11-06
    Sponsor Name:Boehringer Ingelheim bv
    Full Title: An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD)
    Medical condition: Systemic Sclerosis associated Interstitial Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10012977 Diffuse systemic sclerosis LLT
    21.0 100000004859 10036814 Progressive systemic sclerosis LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10042954 Systemic sclerosis pulmonary PT
    21.0 10038738 - Respiratory, thoracic and mediastinal disorders 10025109 Lung involvement in systemic sclerosis LLT
    21.0 100000004859 10042953 Systemic sclerosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) ES (Completed) PT (Ongoing) GB (GB - no longer in EU/EEA) FR (Completed) DK (Completed) BE (Completed) AT (Completed) CZ (Completed) GR (Ongoing) SE (Completed) NO (Completed) FI (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2015-000640-42 Sponsor Protocol Number: 1199.222 Start Date*: 2015-08-26
    Sponsor Name:Boehringer Ingelheim France
    Full Title: A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment ...
    Medical condition: Idiopathic Pulmonary Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001747-31 Sponsor Protocol Number: P160907 Start Date*: 2019-04-09
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Tranplant (LTx) recipients with bronchiolitis obliterans sydrome (BOS) grade 1-2
    Medical condition: Bronchiolitis Obliterating Syndrome (SBO) grade 1 or 2 in patients with pulmonary transplantation.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10029888 Obliterative bronchiolitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004895-21 Sponsor Protocol Number: NEO-BLADE Start Date*: 2014-01-17
    Sponsor Name:The Clatterbridge Cancer Centre NHS Foundation Trust
    Full Title: Phase II randomised placebo controlled NEOadjuvant chemotherapy study of Nintedanib with Gemcitabine and Cisplatin in locally advanced muscle invasive BLADder cancEr
    Medical condition: Muscle invasive bladder cancer - localised muscle invasive carcinoma (T2-T4a N0 M0)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10022877 Invasive bladder cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-003280-11 Sponsor Protocol Number: MA29895 Start Date*: 2016-02-25
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
    Medical condition: Idiopathic Pulmonary Fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) DK (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-002619-14 Sponsor Protocol Number: 1199.36 Start Date*: 2016-07-21
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: INSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with ninteda...
    Medical condition: patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) BE (Completed) GB (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-005814-12 Sponsor Protocol Number: UCL10/0470 Start Date*: 2013-08-19
    Sponsor Name:University College London
    Full Title: Phase II, randomised, placebo controlled, multicentre, feasibility study of low dose (metronomic) cyclophosphamide with or without nintedanib (BIBF 1120) in advanced ovarian cancer (METRO-BIBF)
    Medical condition: Advanced ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-004458-34 Sponsor Protocol Number: Nipawilma_2013 Start Date*: 2014-11-12
    Sponsor Name:University of Essen
    Full Title: A Phase I/II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Nintedanib/Vargatef in Combination With Paclitaxel Chemotherapy for Treatment of ...
    Medical condition: Advanced (unresectable stage III or IV) BRAF V600 wildtype cutaneous malignant melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004919-20 Sponsor Protocol Number: StudioLAM Start Date*: 2016-03-09
    Sponsor Name:MULTIMEDICA S.P.A.
    Full Title: A pilot study of nintedanib for lymphangioleiomyomatosis (LAM)
    Medical condition: Female subjects affected by Llymphangioleiomyomatosis (LAM)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10049459 Lymphangioleiomyomatosis PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
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