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Clinical trials for 2020-004246-11

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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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   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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    1 result(s) found for: 2020-004246-11. Displaying page 1 of 1.
    EudraCT Number: 2020-004246-11 Sponsor Protocol Number: EDO-S101-1002 Start Date*: 2021-09-30
    Sponsor Name:Mundipharma Research Limited
    Full Title: A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients with Ad...
    Medical condition: • Cohort 1: Relapsed/refractory Small Cell Lung Cancer • Cohort 2: Relapsed/refractory Soft Tissue Sarcoma • Cohort 3: Relapsed/refractory Triple-Negative Breast Cancer • Cohort 4: Relapsed/refr...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10041071 Small cell lung cancer stage unspecified LLT
    23.0 100000004864 10084066 Triple negative breast cancer metastatic LLT
    20.0 100000004864 10033130 Ovarian cancer NOS LLT
    21.0 100000004864 10014735 Endometrial cancer NOS LLT
    20.0 100000004864 10002479 Angiosarcoma NOS LLT
    21.1 100000004864 10057043 Dermatofibrosarcoma LLT
    21.1 100000004864 10015103 Epithelioid sarcoma NOS LLT
    20.0 100000004864 10024193 Leiomyosarcoma NOS LLT
    20.0 100000004864 10024631 Liposarcoma NOS LLT
    22.1 100000004864 10082807 Solitary fibrous tumor LLT
    20.0 100000004864 10042866 Synovial sarcoma NOS LLT
    21.1 100000004864 10025556 Malignant fibrous histiocytoma NOS LLT
    20.0 100000004864 10029276 Neurofibrosarcoma NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) IT (Completed)
    Trial results: View results
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    Query did not match any studies.
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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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