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Clinical trials for Tucatinib

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   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).

    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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    14 result(s) found for: Tucatinib. Displaying page 1 of 1.
    EudraCT Number: 2021-002491-39 Sponsor Protocol Number: SGNTUC-028 Start Date*: 2022-02-11
    Sponsor Name:Seagen Inc.
    Full Title: A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05)
    Medical condition: Unresectable locally-advanced or metastatic HER2+ 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
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) PT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) IT (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) CZ (Trial now transitioned) FI (Trial now transitioned) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002801-12 Sponsor Protocol Number: ONT-380-206 Start Date*: 2017-08-07
    Sponsor Name:Seagen Inc.
    Full Title: Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastati...
    Medical condition: Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
    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
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) CZ (Completed) BE (Completed) DK (Completed) FR (Completed) PT (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002672-40 Sponsor Protocol Number: SGNTUC-029 Start Date*: 2022-09-20
    Sponsor Name:Seagen Inc.
    Full Title: An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Su...
    Medical condition: unresectable or metastatic HER2+ colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    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) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) SK (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) FR (Trial now transitioned) HU (Trial now transitioned) IE (Trial now transitioned) PT (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) AT (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000540-60 Sponsor Protocol Number: SGNTUC-017 Start Date*: 2020-08-10
    Sponsor Name:Seattle Genetics, Inc.
    Full Title: MOUNTAINEER: A Phase 2, Open Label Study of Tucatinib Combined with Trastuzumab in Patients with HER2+ Metastatic Colorectal Cancer
    Medical condition: HER2+ Metastatic Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-005017-39 Sponsor Protocol Number: SGNTUC-016 Start Date*: 2021-01-08
    Sponsor Name:Seagen Inc.
    Full Title: Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast canc...
    Medical condition: Unresectable locally-advanced or metastatic HER2+ breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) DK (Trial now transitioned) FR (Trial now transitioned) AT (Completed) BE (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-002561-18 Sponsor Protocol Number: GEICAM/2020-08 Start Date*: 2022-11-04
    Sponsor Name:GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
    Full Title: Single arm phase II study of the efficacy and safety of the combination of Trastuzumab plus TUCAtinib plus viNorelbine in patients with HER2-positive non-resectable locally advanced or metastatic b...
    Medical condition: Non-resectable locally advanced or metastatic HER2-positive breast cancer.
    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: 2020-002512-49 Sponsor Protocol Number: PRS-343-PCS_09_20 Start Date*: 2022-06-13
    Sponsor Name:Pieris Pharmaceuticals, Inc.
    Full Title: A Phase 2, Multi-Center, Open-Label Study of Cinrebafusp Alfa (PRS-343) in Combination with Ramucirumab and Paclitaxel in Patients with HER2-Positive Gastric or Gastroesophageal Junction (GEJ) Aden...
    Medical condition: HER2-Positive Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-004873-29 Sponsor Protocol Number: SGNTUC-019 Start Date*: 2021-05-31
    Sponsor Name:Seagen Inc.
    Full Title: A Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations
    Medical condition: Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations
    Disease: Version SOC Term Classification Code Term Level
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008593 Cholangiocarcinoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017614 Gallbladder cancer PT
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025697 Malignant neoplasm of ampulla of Vater PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10064467 Urothelial carcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008342 Cervix carcinoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10046766 Uterine cancer 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: BE (Trial now transitioned) NL (Ongoing) DE (Trial now transitioned) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005735-79 Sponsor Protocol Number: UC-BCG-2011 Start Date*: 2021-09-02
    Sponsor Name:UNICANCER
    Full Title: Treatment with Tucatinib in addition to Pertuzumab and Trastuzumab in patients with HER2-positive metastatic breast cancer after local therapy of isolated brain progression
    Medical condition: HER2-positive metastatic breast cancer with isolated brain progression (defined as new or progressive brain metastases with stable or responding systemic disease) after complete local treatment.
    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
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006128 Brain metastases LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    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: 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)
    EudraCT Number: 2019-004531-22 Sponsor Protocol Number: D967JC00001 Start Date*: 2021-05-17
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination w...
    Medical condition: HER2-positive Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 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, Female
    Trial protocol: DE (Trial now transitioned) FR (Completed) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    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: 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
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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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