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Clinical trials for Cyclin Dependent Kinase 5

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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

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    12 result(s) found for: Cyclin Dependent Kinase 5. Displaying page 1 of 1.
    EudraCT Number: 2018-001180-23 Sponsor Protocol Number: 1042-CDD-3001 Start Date*: 2018-12-06
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults with Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed b...
    Medical condition: Treatment of seizures in children and young adults with genetically confirmed cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032062 Other forms of epilepsy, with intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Ongoing) FR (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-001315-44 Sponsor Protocol Number: TAK-935-18-002(OV935) Start Date*: 2022-05-24
    Sponsor Name:Takeda Development Center America, Inc.
    Full Title: A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Patients With 15Q Duplication Syndrome or CDKL5 Deficiency Disorder (ARCADE Study)
    Medical condition: Epileptic Encephalopathies: Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10073682 Dravet syndrome LLT
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    22.1 10010331 - Congenital, familial and genetic disorders 10083005 CDKL5 deficiency disorder PT
    23.0 10010331 - Congenital, familial and genetic disorders 10083952 Dup15q syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001722-42 Sponsor Protocol Number: GEINO-13 Start Date*: 2015-07-22
    Sponsor Name:GRUPO ESPAÑOL DE INVESTIGACIÓN EN NEUROONCOLOGGÍA (GEINO)
    Full Title: Phase II, pilot, open label, multicenter and prospective clinical trial to evaluate the safety and activity of Palbociclib (PD0332991), a cyclin-dependent kinase 4/6 (CDK4 and CDK6) inhibitor, in p...
    Medical condition: Recurrent anaplasic oligodendroglioma or oligoastrocytome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001040-62 Sponsor Protocol Number: GBG78/BIG1-13 Start Date*: 2013-11-14
    Sponsor Name:GBG Forschungs GmbH
    Full Title: Phase III study evaluating palbociclib (PD-0332991), a cyclin-dependent kinase (CDK) 4/6 inhibitor, in patients with hormone-receptor positive, HER2 normal primary breast cancer with high relapse r...
    Medical condition: About one-third of patient with hormone-receptor positive, HER2 negative breast cancer and residual disease after standard of care - including adequate surgery - have a substantial risk of relapse ...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006200 Breast cancer stage II PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006202 Breast cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006201 Breast cancer stage III PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071113 Node-positive breast cancer LLT
    21.1 100000004865 10025025 Lumpectomy (breast cancer) LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073289 Premenopausal breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070575 Estrogen receptor positive breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) ES (Completed) AT (Completed) IE (Completed) FR (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2018-000157-41 Sponsor Protocol Number: UoL001343 Start Date*: 2019-06-07
    Sponsor Name:The University of Liverpool
    Full Title: NEO21-RS: A phase II randomised study of the cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with oestrogen suppression therapy versus oestrogen suppression therapy alone as neoadj...
    Medical condition: ER-positive, HER2-negative breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-002821-39 Sponsor Protocol Number: MCLA-128-CL02 Start Date*: 2017-11-13
    Sponsor Name:Merus N.V.
    Full Title: Phase 2 study of MCLA-128-based combinations in metastatic breast cancer (MBC): MCLA-128/trastuzumab/chemotherapy in HER2-positive MBC and MCLA-128/endocrine therapy in estrogen receptor positive a...
    Medical condition: Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) PT (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004201-33 Sponsor Protocol Number: IMMU-132-09 Start Date*: 2019-08-16
    Sponsor Name:Immunomedics, Inc.
    Full Title: Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Nega...
    Medical condition: Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006198 Breast cancer recurrent PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) NL (Completed) ES (Ongoing) BE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003896-37 Sponsor Protocol Number: ODO-TE-B201 Start Date*: 2019-06-18
    Sponsor Name:Odonate Therapeutics, Inc.
    Full Title: A Multinational, Multicenter, Phase 2 Study of Tesetaxel plus a Reduced Dose of Capecitabine in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer ...
    Medical condition: breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061020 Breast cancer male PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006201 Breast cancer stage III PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006202 Breast cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-004715-41 Sponsor Protocol Number: ODO-TE-B202 Start Date*: 2019-12-24
    Sponsor Name:Odonate Therapeutics, Inc.
    Full Title: A Multicenter, Phase 2 Study of Tesetaxel plus Three Different PD-(L)1 Inhibitors in Patients with Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly...
    Medical condition: Breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061020 Breast cancer male PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006201 Breast cancer stage III PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006202 Breast cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) BE (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-000199-20 Sponsor Protocol Number: ML43171 Start Date*: 2022-07-27
    Sponsor Name:Genentech, Inc.
    Full Title: A PHASE III RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT PLUS EVEROLIMUS COMPARED WITH EXEMESTANE PLUS EVEROLIMUS IN PATIENTS WITH ESTROGEN RECEPTOR-...
    Medical condition: Estrogen Receptor (ER)-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer previously treated with a CDK4/6 inhibitor and endocrine therapy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070575 Estrogen receptor positive breast cancer LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083232 HER2 negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-001087-10 Sponsor Protocol Number: ELA-0121 Start Date*: 2022-11-21
    Sponsor Name:Stemline Therapeutics, Inc
    Full Title: An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative B...
    Medical condition: Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-001648-24 Sponsor Protocol Number: MedOPP321_ABIGAIL Start Date*: 2021-06-23
    Sponsor Name:MEDICA SCIENTIA INNOVATION RESEARCH S.L.
    Full Title: randomized, 2-arm, open-label, phase II study of abemaciclib combined with endocrine therapy (letrozole or fulvestrant) with or without a short course of induction chemotherapy with paclitaxel as f...
    Medical condition: Previously untreated unresectable locally advanced or metastatic hormone receptor (HR)-positive/ human epidermal growth factor receptor 2 (HER2)-negative breast cancer with aggressive disease crite...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072740 Locally advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing) PT (Ongoing)
    Trial results: (No results available)
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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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