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Clinical trials for Orteronel

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 ).  
     
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    9 result(s) found for: Orteronel. Displaying page 1 of 1.
    EudraCT Number: 2012-001539-30 Sponsor Protocol Number: C21013 Start Date*: 2012-09-27
    Sponsor Name:Millennium Pharmaceuticals, Inc.
    Full Title: A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naïve Patients with Castration-Resistant Prostate Cancer
    Medical condition: progressive castration-resistant prostate cancer.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IE (Completed) GR (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2010-018661-35 Sponsor Protocol Number: C21004 Start Date*: 2010-10-14
    Sponsor Name:Millennium Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant...
    Medical condition: Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    12.1 10036909 Prostate cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Completed) HU (Completed) EE (Completed) BE (Completed) SK (Completed) LV (Completed) FI (Completed) NL (Completed) ES (Completed) LT (Completed) CZ (Completed) AT (Completed) GB (Completed) PT (Completed) SE (Completed) IE (Completed) DE (Completed) PL (Completed) IT (Completed) BG (Completed) GR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2012-000136-26 Sponsor Protocol Number: C21012 Start Date*: 2012-05-07
    Sponsor Name:Millennium Pharmaceuticals, Inc.
    Full Title: A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
    Medical condition: metastatic castration-resistant prostate cancer (mCRPC)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GR (Completed) IE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-003128-35 Sponsor Protocol Number: GETHI-2013-01 Start Date*: 2014-06-05
    Sponsor Name:Grupo Español de Tumores Huérfanos e Infrecuentes (GETHI)
    Full Title: Open label phase II clinical trial of Orteronel (TAK-700) in metastatic or advanced non-resectable granulosa cell ovarian tumors. The Greko II study.
    Medical condition: Metastatic or advanced non-resectable granulosa cell ovarian tumors
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057376 Ovarian granulosa-theca cell tumour PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-018662-23 Sponsor Protocol Number: C21005 Start Date*: 2010-10-14
    Sponsor Name:Millennium Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK 700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Th...
    Medical condition: Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy
    Disease: Version SOC Term Classification Code Term Level
    12.1 10060862 Prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Completed) EE (Completed) BE (Completed) SK (Completed) SE (Completed) FI (Completed) LT (Completed) NL (Completed) CZ (Completed) ES (Completed) AT (Completed) GB (Completed) PT (Completed) IE (Completed) GR (Completed) DE (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-002122-67 Sponsor Protocol Number: 1211 Start Date*: 2013-12-05
    Sponsor Name:EORTC
    Full Title: Phase II randomized comparative trial of TAK-700 (Orteronel) versus bicalutamide in metastatic prostate cancer patients failing 1st line treatment with LHRH analogs or surgical castration.
    Medical condition: metastatic prostate cancer patients failing 1st line treatment with LHRH analogs or surgical castration
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Prematurely Ended) IT (Prematurely Ended) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-002965-39 Sponsor Protocol Number: RHMCAN0890 Start Date*: 2013-04-29
    Sponsor Name:Swiss Group for Clinical Cancer Research (SAKK)
    Full Title: Orteronel maintenance therapy in patients with metastatic castration resistant prostate cancer and non-progressive disease after first-line docetaxel therapy: A multicenter randomized double-blind ...
    Medical condition: Castration Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-000478-42 Sponsor Protocol Number: 008285QM Start Date*: 2013-02-18
    Sponsor Name:Queen Mary, University of London
    Full Title: NEPTUNE: A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate Cancer
    Medical condition: High or Intermediate Risk, Untreated, Clinically Localised Prostate Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004103-20 Sponsor Protocol Number: INO-VT-464-CL-001 Start Date*: 2011-10-13
    Sponsor Name:Innocrin Pharmaceuticals, Inc.
    Full Title: A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Seviteronel in Subjects with Castration-Resistant Prostate Cancer
    Medical condition: Castration-resistant prostate cancer (CRPC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) GR (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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