Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Plitidepsin

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    9 result(s) found for: Plitidepsin. Displaying page 1 of 1.
    EudraCT Number: 2005-001161-34 Sponsor Protocol Number: APL-B-016-05 Start Date*: 2005-10-03
    Sponsor Name:Pharma Mar SA
    Full Title: Phase I-II multicenter, randomized, open-label, clinical and pharmacokinetic study of plitidepsin, administered alone or in combination with dacarbazine, as front-line therapy to subjects with unre...
    Medical condition: unresectable advanced melanoma
    Disease: Version SOC Term Classification Code Term Level
    5.0 10027150 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2022-002489-34 Sponsor Protocol Number: AV-APL-B-002-22 Start Date*: 2023-02-09
    Sponsor Name:Pharma Mar, S.A.
    Full Title: A Multicentre, Open label, Randomised, Controlled, Basket, Pragmatic, Phase II, Clinical and Translational Study to Determine the Efficacy and Safety of Plitidepsin versus Control in Immunocompromi...
    Medical condition: Immunocompromised Adult Patients with Symptomatic COVID-19 requiring Hospital Care
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084272 SARS-CoV-2 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) HU (Prematurely Ended) PT (Prematurely Ended) PL (Completed) IT (Prematurely Ended) BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-005951-19 Sponsor Protocol Number: APL-D-003-20 Start Date*: 2021-06-08
    Sponsor Name:Pharma Mar, S.A.
    Full Title: A Phase 3, Multicentre, Randomised, Controlled Trial to Determine the Efficacy and Safety of Two Dose Levels of Plitidepsin Versus Control in Adult Patients Requiring Hospitalisation for Management...
    Medical condition: moderate COVID-19 infection
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084272 SARS-CoV-2 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BG (Prematurely Ended) GR (Prematurely Ended) PT (Prematurely Ended) ES (Prematurely Ended) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2009-016138-29 Sponsor Protocol Number: APL-C-001-09 Start Date*: 2010-05-06
    Sponsor Name:Pharma Mar, S.A.
    Full Title: “Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination with Dexamethasone vs. Dexamethasone Alone in Patients with Relapsed/Refractory Multiple Myeloma”.
    Medical condition: Relapsed/Refractory Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    12.1 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) ES (Completed) AT (Completed) NL (Completed) DE (Completed) BE (Completed) CZ (Completed) IT (Completed) GR (Completed) IE (Completed) PT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-001909-14 Sponsor Protocol Number: APL-B-021-13 Start Date*: 2016-03-14
    Sponsor Name:Pharma Mar, S.A.
    Full Title: A Phase II Study of Plitidepsin in Patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.
    Medical condition: Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10002453 Angioimmunoblastic T-cell lymphoma refractory PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) CZ (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010980-18 Sponsor Protocol Number: APL-B-019-08 Start Date*: 2009-06-29
    Sponsor Name:Pharma Mar, S.A.
    Full Title: Efficacité et Tolérance de la Plitidepsine chez les patients souffrant d’un liposarcome dédifférencié (DLPS) avancé, non opérable ou métastatique, en rechute/réfractaire : Une étude exploratoire mu...
    Medical condition: DEDIFFERENTIATED LIPOSARCOMA (DLPS)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10024627 Liposarcoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003486-29 Sponsor Protocol Number: APL-B-022-15 Start Date*: 2016-07-29
    Sponsor Name:Pharma Mar, S.A.
    Full Title: Phase II Trial of Plitidepsin (Aplidin®) in Combination with Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to bortezomib and lenalidomide .
    Medical condition: Multiple Myeloma Double Refractory.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-019790-15 Sponsor Protocol Number: APL-B-020-10 Start Date*: 2010-09-06
    Sponsor Name:PHARMA MAR
    Full Title: Open-label, Phase II Clinical Trial of Aplidin (Plitidepsin) in Patients with Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia (Post-PV/ET) Myelofibrosis
    Medical condition: - primary myelofibrosis (PMF), - post-polycythemia vera myelofibrosis (post-PV MF), or - post-essential thrombocythemia myelofibrosis (post-ET MF).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028537 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-001117-34 Sponsor Protocol Number: APL-B-013-02 Start Date*: 2004-10-13
    Sponsor Name:Pharma Mar S.A.
    Full Title: A Phase II Multicenter,Open-Label, Clinical And Pharmacokinetic Study Of Aplidin® As A 1-Hour Weekly IV Infusion, In Patients With Relapsed Or Refractory aggressive non-Hodgkin’s Lymphoma.
    Medical condition: Aggressive non-Hodgkin’s Lymphoma.For aggressive NHL patient cure is still the target of therapy and a CR is a prerequisite to achieve this goal. Salvage therapy needs more aggressive experimental ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed May 07 14:25:00 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA