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Clinical trials for Melphalan/HDS

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   44380   clinical trials with a EudraCT protocol, of which   7392   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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    3 result(s) found for: Melphalan/HDS. Displaying page 1 of 1.
    EudraCT Number: 2014-001585-98 Sponsor Protocol Number: PHP-HCC-202 Start Date*: 2014-06-27
    Sponsor Name:Delcath Systems, Inc
    Full Title: An International Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Melphalan/HDS Treatment in Patients with Unresectable Hepatocellular Carcinoma or Intra hepatic Cholangiocarcinoma.
    Medical condition: unresectable hepatocellular carcinoma (HCC) confined to the liver and Intra hepatic Cholangiocarcinoma confined to the liver.
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10019828 Hepatocellular carcinoma non-resectable LLT
    18.1 100000004864 10073077 Intrahepatic cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003812-10 Sponsor Protocol Number: PHP-ICC-203 Start Date*: 2017-08-29
    Sponsor Name:Delcath Systems Inc.
    Full Title: A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Stand...
    Medical condition: Intrahepatic cholangiocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10073077 Intrahepatic cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-000417-44 Sponsor Protocol Number: PHP-OCM-301A Start Date*: 2016-03-31
    Sponsor Name:Delcath Systems, Inc
    Full Title: A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma.
    Medical condition: Hepatic-Dominant Ocular Melanoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068117 Metastatic ocular melanoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Prematurely Ended) AT (Prematurely Ended) BE (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    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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