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Clinical trials for Neratinib

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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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   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).

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    22 result(s) found for: Neratinib. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2019-001559-38 Sponsor Protocol Number: GEICAM/2018-06 Start Date*: 2022-01-20
    Sponsor Name:GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
    Full Title: A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Can...
    Medical condition: HER2+, HR+ Early stage Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER2 positive breast cancer PT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083234 Hormone receptor positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-004743-68 Sponsor Protocol Number: PUMA-NER-4201 Start Date*: 2014-05-06
    Sponsor Name:Puma Biotechnology, Inc.
    Full Title: A Phase 2 Study of Neratinib and Neratinib Plus Temsirolimus in Patients with Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations
    Medical condition: Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations
    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: FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-000710-11 Sponsor Protocol Number: SOLTI-1718 Start Date*: 2020-04-08
    Sponsor Name:SOLTI
    Full Title: Targeting EGFR/ERBB2 with Neratinib in Hormone Receptor (HR)-positive/HER2-negative HER2-enriched advanced/metastatic breast cancer (NEREA trial)
    Medical condition: Pre and post-menopausal women and men with locally advanced or metastatic HR+/HER2-negative endocrine resistant breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) PT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001896-35 Sponsor Protocol Number: PUMA-NER-6203 Start Date*: 2020-01-30
    Sponsor Name:Puma Biotechnology, Inc
    Full Title: An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib
    Medical condition: HER2 amplified (HER2+) stage 1 through stage 4 primary adenocarcinoma of the breast
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006199 Breast cancer stage I PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006200 Breast cancer stage II PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006201 Breast cancer stage III PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006202 Breast cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed)
    Trial results: View results
    EudraCT Number: 2012-004492-38 Sponsor Protocol Number: PUMA-NER-1301 Start Date*: 2013-07-30
    Sponsor Name:Puma Biotechnology, Inc.
    Full Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2-Directed Regimens in the Metastati...
    Medical condition: HER2+ Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) FI (Completed) IT (Completed) BE (Completed) CZ (Completed) ES (Completed) AT (Completed) SE (Completed) IE (Completed) DK (Prematurely Ended) PT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2008-001662-85 Sponsor Protocol Number: 3144A1-2206-WW Start Date*: 2008-11-24
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: Phase 1/2 Randomized, Open-label, Three Arm Study of Neratinib (HKI-272) vs. Neratinib + Capecitabine vs. Lapatinib + Capecitabine, in Subjects with Solid Tumors and ErbB-2 Positive Metastatic or l...
    Medical condition: Solid tumors (part 1) and metastatic breast cancer (part 2)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065252 Solid tumor LLT
    9.1 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) HU (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: 2015-004374-15 Sponsor Protocol Number: PUMA-NER-6201 Start Date*: 2018-04-13
    Sponsor Name:Puma Biotechnology, Inc.
    Full Title: An Open Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis
    Medical condition: Early Stage HER2+ Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2022-002582-15 Sponsor Protocol Number: NerHer-1 Start Date*: 2023-03-20
    Sponsor Name:Medical University Graz
    Full Title: Phase II Study of Neratinib and Trastuzumab +/- Vinorelbine p.o. in Pre-treated Metastatic HER2-positive Breast Cancer (Ner-Her-1)
    Medical condition: Patients with histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive metastatic breast cancer (mBC) pretreated with trastuzumab, pertuzumab, and/or trastuzumab emtansine...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-007345-31 Sponsor Protocol Number: 3144A2-3004-WW Start Date*: 2009-08-05
    Sponsor Name:Puma Biotechnology, Inc
    Full Title: A Randomized Double-blind Placebo-Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women With Early-Stage HER-2/neu Overexpressed/Amplified Breast Cancer.
    Medical condition: Her2 overexpressed, early stage breast cancer (adjuvant treatment stage)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10006173 Breast adenocarcinoma LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Completed) DE (Completed) IT (Completed) SK (Completed) CZ (Completed) ES (Completed) BE (Completed) GB (Completed) LT (Completed) NL (Completed) FR (Completed) DK (Completed) SE (Completed) GR (Completed) MT (Completed) BG (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2012-005037-37 Sponsor Protocol Number: 10-005 Start Date*: 2013-10-02
    Sponsor Name:Puma Biotechnology, Inc.
    Full Title: A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients with Metastatic HER2-Amplified or Triple-Negative Breast Cancer
    Medical condition: advanced breast carcinoma in patients with trastuzumab-refractory HER2-amplified disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072737 Advanced breast cancer LLT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2008-005425-11 Sponsor Protocol Number: 3144A2-3003/B1891003 Start Date*: 2009-01-14
    Sponsor Name:Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA
    Full Title: A Phase 2 Randomized Open Label Study of Neratinib versus Lapatinib plus Capecitabine for the Treatment of ErbB-2 Positive Locally Advanced or Metastatic Breast Cancer
    Medical condition: Locally advanced or metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    14.0 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) SI (Completed) BE (Completed) DE (Completed) ES (Completed) CZ (Completed) IT (Prematurely Ended) GR (Completed) FR (Completed) AT (Completed) GB (Completed) BG (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-000824-21 Sponsor Protocol Number: IJB-NERABRAIN-ODN-007 Start Date*: 2021-10-05
    Sponsor Name:Institut Jules Bordet
    Full Title: An open label phase II study to evaluate neratinib for treatment and prevention of subsequent CNS event(s) in patients with brain metastasis of advanced HER2 positive breast cancer
    Medical condition: HER2 positive breast cancer patients with brain metastases
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004391-35 Sponsor Protocol Number: NSABP-FB7 Start Date*: 2014-02-18
    Sponsor Name:Puma Biotechnology Inc.
    Full Title: A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens with Weekly Paclitaxel plus Neratinib or Trastuzumab or Neratinib and Trastuzumab Followed by Doxorubicin and Cyclophosp...
    Medical condition: Locally advanced HER2-positive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed) ES (Completed) PT (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: 2007-007885-39 Sponsor Protocol Number: 3144A1-2204-WW Start Date*: 2008-05-27
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: A Phase I/II Study of HKI-272 in Combination With Vinorelbine in Subjects With Solid Tumors and Metastatic Breast Cancer.
    Medical condition: Solid tumors (part 1) and metastatic breast cancer (part 2).
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) PL (Completed) FR (Completed) NL (Completed) GB (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2014-005006-38 Sponsor Protocol Number: SOLTI-1303 Start Date*: 2015-03-30
    Sponsor Name:SOLTI
    Full Title: PATRICIA: A Phase II clinical trial of palbociclib and trastuzumab with or without letrozole in postmenopausal pretreated HER2-positive locally advanced or metastatic breast cancer patients
    Medical condition: Postmenopausal pretreated HER2-positive locally advanced or metastatic breast cáncer patients
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Restarted)
    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: 2020-000245-13 Sponsor Protocol Number: SOLTI-1907 Start Date*: 2021-03-04
    Sponsor Name:SOLTI
    Full Title: A Phase II with 2 parallel cohorts clinical trial targeting estrogen receptor negative or PAM50 non-luminal disease with Atezolizumab in combination with Trastuzumab and Vinorelbine in HER2-positiv...
    Medical condition: Pre- and post-menopausal women with locally advanced or metastatic HER2-positive breast cancer who have progressed to trastuzumab/pertuzumab and T-DM1.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001246-36 Sponsor Protocol Number: ACE-Breast-03 Start Date*: 2022-02-22
    Sponsor Name:Ambrx, Inc.
    Full Title: A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM1, and/or T-DXd, and/or Tucatinib-containing Regimens
    Medical condition: Metastatic Breast Cancer Resistant or Refractory
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) ES (Prematurely Ended) IT (Prematurely Ended) DE (Completed)
    Trial results: (No results available)
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