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Clinical trials for DOTA-TATE

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   44343   clinical trials with a EudraCT protocol, of which   7372   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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    5 result(s) found for: DOTA-TATE. Displaying page 1 of 1.
    EudraCT Number: 2021-004155-16 Sponsor Protocol Number: CAAA601A42101 Start Date*: 2022-06-07
    Sponsor Name:Novartis Pharma AG
    Full Title: A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination with Carboplatin, Etoposide ...
    Medical condition: Extensive-Stage Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041068 Small cell lung cancer extensive stage PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-006068-99 Sponsor Protocol Number: DuoNen2020 Start Date*: 2021-09-20
    Sponsor Name:Narodowe Centrum Badań Jądrowych, Ośrodek Radioizotopów POLATOM
    Full Title: Tandem therapy LutaPol/ItraPol (177Lu / 90Y-DOTATATE) as an effective method in the treatment of neuroendocrine neoplasms, Acronym: DuoNen, 2019 / ABM / 01/00077
    Medical condition: Diagnosed and confirmed histopathologically disseminated or locally unresectable, well and moderately differentiated (G1 and G2) neuroendocrine neoplasms of the gastrointestinal tract (GEP-NET)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001306-30 Sponsor Protocol Number: PROICM2021-04REL Start Date*: 2021-09-13
    Sponsor Name:Institut Régional du Cancer de Montpellier
    Full Title: A prospective randomized phase II study to assess the schemas of retreatment with Lutathera® ([177Lu]Lu-DOTA-TATE) in patients with new progression of intestinal well-differentiated neuroendocrine ...
    Medical condition: Patients with new progression of intestinal well-differentiated neuroendocrine tumor.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10062476 Neuroendocrine tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001562-15 Sponsor Protocol Number: CAAA601A22301 Start Date*: 2019-11-15
    Sponsor Name:Advanced Accelerator Applications SA
    Full Title: This is a multicenter, stratified, randomized, open-label comparator-controlled, Phase III study in patients with somatostatin receptor positive, well-differentiated G2 and G3, advanced GEP NETs, d...
    Medical condition: Patients with somatostatin receptor positive, well-differentiated G2 and G3, advanced GEP NETs
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052399 Neuroendocrine tumour PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077559 Gastroenteropancreatic neuroendocrine tumour disease PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077560 Gastroenteropancreatic neuroendocrine tumor disease LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) DE (Ongoing) NL (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-001697-17 Sponsor Protocol Number: A-94-52030-268 Start Date*: 2014-05-23
    Sponsor Name:Ipsen Pharma GmbH
    Full Title: PHASE II, MULTICENTRE, OPEN LABEL STUDY TO EVALUATE THE EFFICACY OF THE COMBINATION OF LANREOTIDE AUTOGEL 120 MG AND TEMOZOLOMIDE IN PATIENTS WITH PROGRESSIVE GASTRO-ENTERO-PANCREATIC NEUROENDOCRIN...
    Medical condition: metastatic functioning and non-functioning entero-pancreatic tumours
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (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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