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Clinical trials for Amrubicin

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   44344   clinical trials with a EudraCT protocol, of which   7373   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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    4 result(s) found for: Amrubicin. Displaying page 1 of 1.
    EudraCT Number: 2007-003989-18 Sponsor Protocol Number: AMR PH GL 2007 CL 001 Start Date*: 2008-04-24
    Sponsor Name:Celgene Corporation
    Full Title: A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of ...
    Medical condition: Extensive or limited and sensitive or refractory SCLC after failure of first-line chemotherapy.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10041071 Small cell lung cancer stage unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed) DK (Completed) HU (Completed) NL (Completed) AT (Completed) CZ (Completed) IT (Completed) FR (Completed) ES (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2006-004785-14 Sponsor Protocol Number: CNF1340-SCLC-002 Start Date*: 2007-04-03
    Sponsor Name:Celgene Corporation
    Full Title: A Phase II Trial of Single-Agent Amrubicin in Patients with Extensive Disease Small Cell Lung Cancer that is Refractory or Progressive within 90 Days of Completion of First-Line Platinum-based Chem...
    Medical condition: Extensive Disease Small Cell Lung Cancer that is refractory or progressive
    Disease: Version SOC Term Classification Code Term Level
    8.1 10041068 Small cell lung cancer extensive stage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-001956-11 Sponsor Protocol Number: 08062 Start Date*: 2006-11-21
    Sponsor Name:Celgene International SARL
    Full Title: Randomized Phase II Study of Amrubicin as Single Agent or in Combination with Cisplatin versus Etoposide-Cisplatin as first-Line Treatment in Patients with Extensive Stage SCLC
    Medical condition: Small Cell Lung Cancer (extensive stage)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10041068 Small cell lung cancer extensive stage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-004793-26 Sponsor Protocol Number: TPU-TAS-102-201 Start Date*: 2013-02-18
    Sponsor Name:TAIHO PHARMA USA, INC
    Full Title: AN OPEN-LABEL, RANDOMIZED, PHASE 2 STUDY COMPARING TAS-102 VERSUS TOPOTECAN OR AMRUBICIN IN PATIENTS REQUIRING SECONDLINE CHEMOTHERAPY FOR SMALL CELL LUNG CANCER THAT IS REFRACTORY OR SENSITIVE TO ...
    Medical condition: Small Cell Lung Cancer that is refractory or sensitive to first-line platinum-based chemotherapy.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10041067 Small cell lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (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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