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Clinical trials for Afatinib

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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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    67 result(s) found for: Afatinib. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2017-001284-20 Sponsor Protocol Number: BIOGIO Start Date*: 2017-07-05
    Sponsor Name:Erasmus MC Cancer Institute
    Full Title: The effects of the proton pump inhibitor esomeprazole on the bioavailability of afatinib (Giotrif®) in patients with non-small cell lung cancer (NSCLC) 'the BIO-GIO study'
    Medical condition: Non small cell lung cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003411-34 Sponsor Protocol Number: 1200.264 Start Date*: 2017-06-21
    Sponsor Name:BSMO
    Full Title: Precision 2: an open explorative phase II, open label study of afatinib in the treatment of advanced cancer carrying an EGFR, a HER2 or a HER3 mutation.
    Medical condition: cancers harbouring an EGFR mutation (excluding non-squamous non- small cell lung cancer, a registered indication), a HER2 mutation or a HER3 mutation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002766-31 Sponsor Protocol Number: 1200.277 Start Date*: 2018-11-23
    Sponsor Name:UCL
    Full Title: A phase 2, single arm, European multi-center trial evaluating the efficacy of afatinib as first line or later line treatment in advanced chordoma
    Medical condition: Chordoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008747 Chordoma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000392-14 Sponsor Protocol Number: 1200.131 Start Date*: 2011-07-27
    Sponsor Name:Boehringer Ingelheim Limited
    Full Title: LUX-Head & Neck 2 A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary...
    Medical condition: Loco-regionally advanced head and neck squamous cell carcinoma with no evidence of disease after chemo-radiotherapy
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Prematurely Ended) BE (Completed) FR (Prematurely Ended) NL (Prematurely Ended) DE (Completed) FI (Prematurely Ended) GR (Prematurely Ended) AT (Prematurely Ended) SE (Prematurely Ended) IT (Completed) CZ (Prematurely Ended) DK (Prematurely Ended) PT (Prematurely Ended) HU (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-002123-10 Sponsor Protocol Number: 1200.120 Start Date*: 2015-04-18
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: Phase I open label, dose escalation trial to determine the MTD, safety, PK and efficacy of afatinib monotherapy in children aged 2 years to <18 years with recurrent/refractory neuroectodermal tumou...
    Medical condition: Paediatric patients with recurrent//refractory high grade glioma (HGG), diffuse intrinsic pontine glioma (DIPG), low grade astrocytoma, neuroblastoma, ependymoma, medulloblastoma/primitive neuroect...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10029091 Neoplasm of unspecified nature of endocrine glands and other parts of nervous system LLT
    18.0 100000004864 10029006 Neoplasm of uncertain behavior of brain and spinal cord LLT
    18.0 100000004864 10029050 Neoplasm of uncertain behaviour of connective and other soft tissue LLT
    18.0 100000004864 10028992 Neoplasm CNS LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) DE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) FR (Completed) DK (Completed) IT (Completed) NL (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2020-003025-37 Sponsor Protocol Number: 2020AFA01 Start Date*: 2020-10-06
    Sponsor Name:VU University Medical Center
    Full Title: COMBINING AFATINIB AND CONCURRENT CHEMOTHERAPY, FOLLOWED BY OSIMERTINIB AND CONCURRENT CHEMOTHERAPY, IN UNTREATED EGFR POSITIVE NSCLC TUMORS
    Medical condition: non small cell lung cancer (NSCLC)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-024454-10 Sponsor Protocol Number: 1200.89 Start Date*: 2011-07-21
    Sponsor Name:Boehringer Ingelheim
    Full Title: An open label, phase II trial of afatinib with or without vinorelbine for the treatment of HER2-overexpressing Inflammatory Breast Cancer
    Medical condition: Locally advanced or metastic Inflammatory Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004864 10021974 Inflammatory breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-002197-31 Sponsor Protocol Number: AFAMOSI Start Date*: 2020-05-12
    Sponsor Name:Universitätsmedizin Mainz, Interdisziplinäres Zentrum klinische Studien
    Full Title: AFAMOSI: Prospective, randomized, multicenter Phase IV study to evaluate the efficacy and safety of afatinib followed by osimertinib compared to osimertinib in patients with EGFRmutated/T790M Mutat...
    Medical condition: EGFR mutated non-squamous NSCLC
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038666 Respiratory and mediastinal neoplasms malignant and unspecified HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2010-021415-16 Sponsor Protocol Number: 1200.67 Start Date*: 2011-09-14
    Sponsor Name:Boehringer Ingelheim
    Full Title: Randomised phase II study of afatinib alone or in combination with vinorelbine versus investigator’s choice of treatment in patients with HER2-positive breast cancer with progressive brain metastas...
    Medical condition: HER2 positive breast cancer with progressive brain metastases after trastuzumab or lapatinib based therapy
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006198 Breast cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FI (Completed) ES (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-005098-35 Sponsor Protocol Number: ETOP7-14NICHE Start Date*: 2015-05-18
    Sponsor Name:ETOP (European Thoracic Oncology Platform)
    Full Title: Afatinib in pretreated patients with advanced NSCLC harbouring HER2 exon 20 mutations
    Medical condition: Advanced stage NSCLC, harbouring HER2 exon 20 mutations
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2010-024164-18 Sponsor Protocol Number: 1200.138 Start Date*: 2011-06-20
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: Single-arm, open-label, monocentric Phase II study evaluating the efficacy and safety of BIBW 2992 (Afatinib) for the treatment of patients with HER2-positive, hormone-refractory prostate cancer af...
    Medical condition: Patients with HER2-positive, hormone-refractory prostate cancer after failure of treatment with docetaxel or ineligible for treatment with docetaxel.
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000391-34 Sponsor Protocol Number: 1200.43 Start Date*: 2011-10-25
    Sponsor Name:Boehringer Ingelheim
    Full Title: LUX-Head & Neck 1 A randomised, open-label, phase III study to evaluate the efficacy and safety of oral afatinib (BIBW 2992) versus intravenous methotrexate in patients with recurrent and/or metas...
    Medical condition: Recurrent and/or metastatic head and neck squamous cell carcinoma in patients who have progessed after platinum based therapy
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DK (Completed) FR (Completed) DE (Completed) GR (Completed) ES (Completed) AT (Completed) CZ (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-002380-24 Sponsor Protocol Number: 1200.125 Start Date*: 2012-02-22
    Sponsor Name:Boehringer Ingelheim España, S.A
    Full Title: LUX-Lung 8: A randomized, open-label Phase III trial of afatinib versus erlotinib in patients with advanced squamous cell carcinoma of the lung as second-line therapy following first-line platinum-...
    Medical condition: Squamous cell carcinoma of the lung requiring second-line therapy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025126 Lung squamous cell carcinoma stage unspecified PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) PT (Completed) GR (Completed) DK (Completed) HU (Completed) IE (Completed) GB (Completed) AT (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-002192-18 Sponsor Protocol Number: TRIO020 Start Date*: 2013-10-17
    Sponsor Name:Translational Research In Oncology
    Full Title: A randomized open-label Phase II study of letrozole plus afatinib (BIBW2992) versus letrozole alone in first-line treatment of advanced ER+, HER2- postmenopausal breast cancer with low ER expression
    Medical condition: Advanced ER+, HER2- postmenopausal breast cancer with low ER expression
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-004537-16 Sponsor Protocol Number: MO11/10085 Start Date*: 2013-01-25
    Sponsor Name:University of Leeds
    Full Title: An Open Label Multi-Centre Preoperative Window of Opportunity Study of Afatinib in Stage Ia to IIb Non-Small Cell Lung Cancer
    Medical condition: Non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10025051 Lung cancer non-small cell stage II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-006198-25 Sponsor Protocol Number: HE7/12 Start Date*: 2012-10-24
    Sponsor Name:Hellenic Cooperative Oncology Group
    Full Title: A Phase II, single-arm clinical trial of administration of cisplatin and 5-fluorouracil with afatinib as first-line therapy in patients with inoperable gastric or gastroesophageal junction cancer
    Medical condition: Inoperable gastric and gastroesophageal junction cancer
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017760 Gastric cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
    EudraCT Number: 2014-001855-22 Sponsor Protocol Number: M14AFS Start Date*: 2015-01-14
    Sponsor Name:Netherlands Cancer Institute- Antoni van Leeuwenhoek Hospital
    Full Title: Phase I/II study with the combination of afatinib and selumetinib in advanced KRAS mutant positive and PIK3CA wildtype non-small cell lung cancer and colorectal cancer
    Medical condition: Patients with histological or cytological proof of advanced KRAS mutant and PIK3CA wildtype non small cell lung cancer (NSCLC) and colorectal cancer (CRC). In part B: for which first-line treatment...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029520 Non-small cell lung cancer stage IIIA PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029515 Non-small cell lung cancer recurrent PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029518 Non-small cell lung cancer stage II PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029519 Non-small cell lung cancer stage III PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010023 Colorectal neoplasms malignant HLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010030 Colorectal cancer recurrent PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010034 Colorectal cancer stage III PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010035 Colorectal cancer stage IV PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010036 Colorectal carcinoma LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052360 Colorectal adenocarcinoma PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001477-41 Sponsor Protocol Number: 1373.1 Start Date*: 2015-11-19
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: A randomised, double blind phase I/II trial to investigate efficacy, immunogenicity and safety of intradermally administered BI 1361849 (CV9202) plus afatinib versus placebo plus afatinib as first-...
    Medical condition: Advanced non-small cell lung cancer (adenocarcinoma) stage IV.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025055 Lung cancer non-small cell stage IV LLT
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001765-41 Sponsor Protocol Number: 1200.137 Start Date*: 2012-02-13
    Sponsor Name:Medizinische Fakultät der Otto-von-Guericke Universität Magdeburg Universitätsklinikum Magdeburg A.ö.R.
    Full Title: Single-arm, open-label, multicentre phase II study evaluating the efficacy and safety of BIBW 2992 (Afatinib) in combination with vinorelbine for the treatment of patients with metastatic breast ca...
    Medical condition: Metastatic breast cancer patients with intermediate HER2 expression (IHC 2+, HER2 FISH-negative)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-024046-29 Sponsor Protocol Number: GEP 11/1010 Start Date*: 2013-05-28
    Sponsor Name:FNCLCC
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067821 Head and neck cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
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