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Clinical trials for ERBB

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   44336   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    14 result(s) found for: ERBB. Displaying page 1 of 1.
    EudraCT Number: 2020-005492-12 Sponsor Protocol Number: BDTX-189-01 Start Date*: 2021-05-27
    Sponsor Name:Black Diamond Therapeutics, Inc.
    Full Title: MasterKey-01: A Phase 1/2, Open-label, Two-part, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB Mutation...
    Medical condition: NSCLC, breast cancer, biliary tract cancer, or cervical cancer, any other solid tumors with specific gene mutations
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) NL (Prematurely Ended) ES (Completed) IT (Prematurely Ended) PL (Completed)
    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: 2005-003944-68 Sponsor Protocol Number: EGF105084 Start Date*: 2006-02-15
    Sponsor Name:GlaxoSmithKline R&D Ltd
    Full Title: A Phase II Study of Lapatinib for Brain Metastases in Subjects with ErbB2-Positive Breast Cancer Following Trastuzumab based Systemic Therapy and Cranial Radiotherapy
    Medical condition: Progressive symptomatic or asymptomatic ErbB2 overexpressing breast cancer brain metastases.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) DE (Completed) GB (Completed) BE (Completed) ES (Completed) GR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-005427-10 Sponsor Protocol Number: 1200.261 Start Date*: 2016-04-29
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: Phase II open label single arm exploratory trial of oral afatinib monotherapy following platinum failure for patients with advanced/metastatic urothelial tract carcinoma with ERBB receptor deregula...
    Medical condition: patients with advanced/metastatic urothelial tract carcinoma with ERBB receptor deregulation
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2005-003767-23 Sponsor Protocol Number: EGF105884 Start Date*: 2006-07-13
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicentre, Phase II Study of Oral Lapatinib in combination with Concurrent Radiotherapy and Cisplatin versus Radiotherapy and Cisplatin alone, in S...
    Medical condition: Stage III, IVa, IVb Squamous Cell Carcinoma of the Head & Neck
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-005912-28 Sponsor Protocol Number: EGF107671 Start Date*: 2007-04-16
    Sponsor Name:GlaxoSmithKline Research & Development Ltd.
    Full Title: Study EGF107671 – a Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radi...
    Medical condition: Brain metastases from ErbB2-positive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    8.1 10006128 Brain metastases LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) ES (Completed) BE (Completed) AT (Completed) FR (Completed) GR (Completed) IT (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002872-42 Sponsor Protocol Number: PUMA-NER-5201 Start Date*: 2014-03-25
    Sponsor Name:Puma Biotechnology, Inc
    Full Title: An Open-Label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR gene amplification
    Medical condition: Cancer tumor with somatic human epidermal growth factor receptor mutation (EGFR, ERBB2 (HER2), ERBB3 (HER3) or EGFR gene amplification
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10065143 Malignant solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed) FI (Completed) GB (GB - no longer in EU/EEA) DK (Completed) BE (Completed) FR (Ongoing) IE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001983-36 Sponsor Protocol Number: AIO-TRK-0114 Start Date*: 2015-06-29
    Sponsor Name:AIO-Studien-gGmbH
    Full Title: Maintaining ERBB blockade in EGFR-mutated lung cancer (MARBLE) - A randomized, open-label, phase II study of maintaining pan-ERBB blockade following platinum-based induction chemotherapy in patient...
    Medical condition: Patients with stage IIIB or IV metastatic non-small-cell lung cancer with somatic EGFR mutation
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    19.0 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: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004063-77 Sponsor Protocol Number: ACCEPT Start Date*: 2013-01-17
    Sponsor Name:Klinikum der Universität München, Anstalt des öffentlichen Rechts
    Full Title: Gemcitabine in Combination with the Oral Irreversible ErbB Inhibitor Afatinib versus Gemcitabine Alone in Patients with Metastatic Pancreatic Cancer: an Explorative Randomized Phase II Trial
    Medical condition: histologically confirmed diagnosis of metastatic pancreatic adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10033575 Pancreas cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-004908-31 Sponsor Protocol Number: PM2734-B-001-08 Start Date*: 2008-11-18
    Sponsor Name:Pharma Mar S.A.
    Full Title: Ensayo clínico y farmacocinético de fase II de infusión de 30 minutos de PM02734 (Irvalec®) cada tres semanas en pacientes con cáncer no microcítico de pulmón (CNMP) epidermoide previamente tratado...
    Medical condition: Cáncer no microcítico de pulmón (CNMP) epidermoide
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029515 Non-small cell lung cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-005247-10 Sponsor Protocol Number: ITCC-003-Tarceva/Roche MO 18461 Start Date*: 2005-07-29
    Sponsor Name:The University Hospitals of Leicester NHS Trust
    Full Title: Phase I study of TARCEVA (Erlotinib Hydrochloride, OSI-774) as a single agent in children with refractory and relapsed malignant brain tumours and in combination with irradiation in newly diagnosed...
    Medical condition: Refractory and relapsed malignant brain tumours and newly diagnosed brain stem glioma.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016622-13 Sponsor Protocol Number: CA187-016 Start Date*: 2010-06-23
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole with Lapatinib + Letrozole in Recurrent or Metastatic Breast Cancer Patients Who Are Hormone Receptor Pos...
    Medical condition: Locally recurrent or metastatic hormone receptor positive (HR+) breast cancer and either: • HER2+ disease with progression while on adjuvant antiendocrine therapy or at any time after adjuvant anti...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-007803-10 Sponsor Protocol Number: 3144A2-3005 Start Date*: 2009-08-26
    Sponsor Name:Puma Biotechnology, Inc
    Full Title: A Randomized, Open-Label, Two-Arm Study of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel as First-Line Treatment for ErbB-2-Positive Locally Recurrent or Metastatic Breast Cancer
    Medical condition: ErbB2 Positive Locally Recurrent or Metastatic Breast Cancer
    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: HU (Completed) DE (Completed) IT (Completed) GB (Completed) ES (Completed) BE (Completed) LV (Completed) PT (Completed) LT (Completed) FR (Completed) GR (Completed) DK (Completed) MT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2006-005573-21 Sponsor Protocol Number: A4021004 Start Date*: 2007-01-26
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: A TWO-ARM RANDOMIZED OPEN LABEL PHASE 2 STUDY OF CP-751,871 IN COMBINATION WITH EXEMESTANE VERSUS EXEMESTANE ALONE AS FIRST LINE TREATMENT FOR POSTMENOPAUSAL PATIENTS WITH HORMONE RECEPTOR POSITIVE...
    Medical condition: Hormone receptor positive advanced breast cancer in postmenopausal women.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) NL (Temporarily Halted) GB (Completed) SE (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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