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Clinical trials for Dacomitinib

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   44363   clinical trials with a EudraCT protocol, of which   7387   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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    18 result(s) found for: Dacomitinib. Displaying page 1 of 1.
    EudraCT Number: 2013-003299-10 Sponsor Protocol Number: M13DAP Start Date*: 2014-01-14
    Sponsor Name:The Netherlands Cancer Institute
    Full Title: Phase I/II study with the combination of dacomitinib and PD-0325901 in metastatic KRAS mutation positive non-small cell lung cancer
    Medical condition: non-small cell lung cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002869-35 Sponsor Protocol Number: CAPLAND Start Date*: 2020-03-10
    Sponsor Name:FONDAZIONE RICERCA TRASLAZIONALE (FORT)
    Full Title: A randomized, non-comparative, phase II study investigating the best epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) sequence in advanced or metastatic non-small-cell lung can...
    Medical condition: Advanced or metastatic untreated EGFR mutation positive NSCLC
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004977-23 Sponsor Protocol Number: DP312804 Start Date*: 2013-04-25
    Sponsor Name:SFJ LungCancer, Ltd.
    Full Title: ARCHER 1050: A RANDOMIZED, OPEN-LABEL, PHASE 3, EFFICACY AND SAFETY STUDY OF DACOMITINIB (PF 00299804) VERSUS GEFITINIB FOR THE FIRST LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON SMALL CELL...
    Medical condition: Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10029514 Non-small cell lung cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-022656-22 Sponsor Protocol Number: A7471009 Start Date*: 2011-09-13
    Sponsor Name:Pfizer, S.L.U.
    Full Title: A randomized double blind phase 3 efficacy and safety study of PF-00299804 versus erlotinib for the treatment of advanced non-small cell lung cancer following progression after, or intolerance to, ...
    Medical condition: Non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) SK (Completed) PL (Completed) HU (Completed) IE (Completed) FI (Completed) BE (Completed) GB (Completed) DE (Completed) AT (Completed) DK (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2014-002175-28 Sponsor Protocol Number: DACOMINT14 Start Date*: 2014-08-04
    Sponsor Name:Fondazione IRCCS Istituto Nazionale dei Tumori
    Full Title: Efficacy and safety of single agent pan-HER inhibitor Dacomitinib in the treatment of locally advanced unresectable or metastatic squamous cell cancer of the skin or with clinical contraindication...
    Medical condition: locally advanced unresectable or metastatic squamous cell cancer of the skin or with clinical contraindication to surgery
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10040808 Skin cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-003590-25 Sponsor Protocol Number: HER-URO01 Start Date*: 2012-12-24
    Sponsor Name:ISTITUTO NAZIONALE PER LA CURA TUMORI
    Full Title: Phase II study of the Pan-HER inhibitor Dacomitinib (PF-00299804) for patients with locally advanced or metastatic squamous cell carcinoma of the penis
    Medical condition: locally advanced/metastatic squamous cell carcinoma of the penis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004671-37 Sponsor Protocol Number: GEINO-11 Start Date*: 2011-12-19
    Sponsor Name:GRUPO ESPAÑOL DE INVESTIGACION EN NEUROONCOLOGIA
    Full Title: Phase II pilot, prospective, open label, multicenter Clinical Trial, to evaluate the safety and efficacy of PF299804, a pan-HER irreversible inhibitor, in patients with recurrent glioblastoma with ...
    Medical condition: Patients with recurrent glioblastoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-003755-41 Sponsor Protocol Number: ERIS Start Date*: 2021-10-12
    Sponsor Name:Region Skåne
    Full Title: ERIS- EGFR-Mutated Lung Cancer in Randomized Investigator-Initiated Study
    Medical condition: EGFR-mutated non-small cell lung cancer (NSCLC) not amenable for curative treatment intention and candidates for EGFR-inhibitor in first line.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-005215-86 Sponsor Protocol Number: CO-1686-008 Start Date*: 2013-05-17
    Sponsor Name:Clovis Oncology, Inc.
    Full Title: A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-small Cell Lung Cancer (NSCLC)
    Medical condition: Previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as erlotinib or gefitinib
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10029514 Non-small cell lung cancer NOS LLT
    19.0 100000004864 10025048 Lung cancer non-small cell recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001687-30 Sponsor Protocol Number: ETOP_15-19 Start Date*: 2020-04-23
    Sponsor Name:European Thoracic Oncology Platform (ETOP)
    Full Title: A randomised non-comparative open label phase II trial of atezolizumab plus bevacizumab, with carboplatin-paclitaxel or pemetrexed, in EGFR mutant non-small cell lung carcinoma with acquired resist...
    Medical condition: Chemotherapy naïve, EGFR mutant non-squamous NSCLC, stage IIIB/C (not amenable to radical therapy) or IV.
    Disease: Version SOC Term Classification Code Term Level
    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
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-005532-23 Sponsor Protocol Number: CO-1686-019 Start Date*: Information not available in EudraCT
    Sponsor Name:Clovis Oncology, Inc.
    Full Title: TIGER-2: A Phase 2, Open-Label, Multicenter, Safety and Efficacy Study of Oral CO 1686 as 2nd Line EGFR-Directed TKI in Patients with Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)
    Medical condition: Previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10029514 Non-small cell lung cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-003296-19 Sponsor Protocol Number: AFM24-101 Start Date*: 2020-03-27
    Sponsor Name:Affimed GmbH
    Full Title: A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients with Advanced Solid Cancers
    Medical condition: Advanced solid malignancies in patients whose disease has progressed after treatment with previous anticancer therapies.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-000730-17 Sponsor Protocol Number: U31402-A-U201 Start Date*: 2021-02-26
    Sponsor Name:DAIICHI SANKYO, INC
    Full Title: HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer(...
    Medical condition: Metastatic or Locally Advanced EGFR mutated Non-Small Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10080083 Advanced lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) AT (Completed) BE (Trial now transitioned) IT (Trial now transitioned) BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-002029-12 Sponsor Protocol Number: ETOP10-16 Start Date*: 2017-04-24
    Sponsor Name:ETOP IBCSG Partners Foundation
    Full Title: A randomised phase II trial of osimertinib and bevacizumab versus osimertinib alone as second-line treatment in stage IIIb-IVb NSCLC with confirmed EGFRm and T790M
    Medical condition: Patients with locally advanced or metastatic (stage IIIb-IVb) EGFRm (exon 19 deletion or exon 21 L858R) NSCLC with T790M resistance mutation at progression on prior EGFR TKI therapy
    Disease: Version SOC Term Classification Code Term Level
    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) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) ES (Ongoing) NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-000707-20 Sponsor Protocol Number: AFM24-102 Start Date*: 2021-09-07
    Sponsor Name:Affimed GmbH
    Full Title: A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination with Atezolizumab in Patients with Selected Advanced/Metastatic...
    Medical condition: Advanced/Metastatic EGFR-expressing Cancers
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2014-000370-19 Sponsor Protocol Number: CO-1686-022 Start Date*: 2015-01-14
    Sponsor Name:Clovis Oncology, Inc.
    Full Title: TIGER-1: A Randomized, Open-Label, Phase 2/3 Study of CO-1686 or Erlotinib as First-Line Treatment of Patients with EGFR-Mutant Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
    Medical condition: First-Line Treatment of Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10029514 Non-small cell lung cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002646-31 Sponsor Protocol Number: CL1-49076-003 Start Date*: 2015-12-10
    Sponsor Name:Laboratorios Servier S. L.
    Full Title: Phase I/II study of oral administration of S 49076 given in combination with gefitinib in patients with EGFR mutated advanced non-small-cell lung cancer who have progressed after treatment with EGF...
    Medical condition: Locally advanced or metastatic non-small-cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10025054 Lung cancer non-small cell stage IIIB LLT
    18.0 100000004864 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004482-14 Sponsor Protocol Number: CEGF816X2101 Start Date*: 2014-08-15
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase I/II, multicenter, open-label study of EGFRmut–TKI EGF816,administered orally in adult patients with EGFRmut solid malignancies
    Medical condition: Solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10049280 Solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Temporarily Halted) FR (Completed) NL (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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