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Clinical trials for Companion diagnostics

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   44336   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.
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    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.
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    5 result(s) found for: Companion diagnostics. Displaying page 1 of 1.
    EudraCT Number: 2013-001966-40 Sponsor Protocol Number: CD001 Start Date*: 2014-01-27
    Sponsor Name:Companion Diagnostics BV
    Full Title: A double blind, randomized, placebo controlled, cross-over, Lybridos dose finding study to validate the predictive power of the diagnostic model for Lybrido and Lybridos efficacy and to identify an...
    Medical condition: Hypoactive Sexual Desire Disorder/SSRI-induced sexual dysfunction
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10040470 Sexual desire disorders HLT
    14.1 100000004873 10020933 Hypoactive sexual desire disorder LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001966-39 Sponsor Protocol Number: CBYL719C2303 Start Date*: 2021-09-27
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-B5: A Phase III, randomized, double-blind, placebo-controlled study of alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with HR-positive, HER2-negative advan...
    Medical condition: Hormone receptor positive, HER2-negative advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) IE (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) FI (Trial now transitioned) DK (Trial now transitioned) PT (Trial now transitioned) BG (Trial now transitioned) PL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003126-25 Sponsor Protocol Number: DZ2019E0001 Start Date*: 2022-02-14
    Sponsor Name:Dizal (Jiangsu) Pharmaceutical Co., Ltd
    Full Title: A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with...
    Medical condition: Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000603-91 Sponsor Protocol Number: CA013-004 Start Date*: 2016-08-30
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 1/2a Study of BMS-986179 Administered in Combination with Nivolumab (BMS- 936558) in Subjects with Advanced Solid Tumors
    Medical condition: Solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001578-31 Sponsor Protocol Number: CINC280A2301 Start Date*: 2020-08-26
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase III, randomized, controlled, open-label, multicenter, global study of capmatinib versus SoC docetaxel chemotherapy in previously treated patients with EGFR wt, ALK negative, locally advance...
    Medical condition: cMET mutated NSCLC
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) NL (Completed) DE (Completed) PT (Completed) FR (Completed) LT (Completed) BE (Completed) IT (Prematurely Ended) BG (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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