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Clinical trials for CDK4

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.
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    16 result(s) found for: CDK4. Displaying page 1 of 1.
    EudraCT Number: 2016-004039-19 Sponsor Protocol Number: GEIS-51 Start Date*: 2017-03-23
    Sponsor Name:Grupo Español de Investigación en Sarcomas (GEIS)
    Full Title: Phase II multicenter trial of palbociclib in second line of advanced sarcomas with CDK4 overexpression.
    Medical condition: Patients with advanced soft tissue sarcomas and osteosarcomas
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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: 2021-002301-10 Sponsor Protocol Number: I3Y-MC-JPEF Start Date*: 2022-02-15
    Sponsor Name:Eli Lilly and Company
    Full Title: postMONARCH: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib plus Fulvestrant to Placebo plus Fulvestrant in Participants with HR+, HER2-, Advan...
    Medical condition: HR+, HER2-, Advanced or Metastatic 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: FR (Trial now transitioned) BE (Trial now transitioned) DK (Trial now transitioned) CZ (Trial now transitioned) ES (Ongoing) HU (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-005637-38 Sponsor Protocol Number: TREnd_trial Start Date*: 2012-09-07
    Sponsor Name:FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI-ONLUS
    Full Title: PHASE 2, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF PD 0332991 (ORAL CDK 4/6 INHIBITOR) MONOTHERAPY AND PD 0332991 IN COMBINATION WITH THE ENDOCRINE THERAPY TO WHICH THE PATIENT HAS PROGRESSED IN...
    Medical condition: ADVANCED BREAST CANCER
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-003672-39 Sponsor Protocol Number: 1202-STBSG Start Date*: 2014-06-30
    Sponsor Name:European Organisation for Research and Treatment of Cancer (EORTC)
    Full Title: Phase II trial of cabazitaxel in metastatic or inoperable locally advanced dedifferentiated liposarcoma
    Medical condition: Locally advanced dedifferentiated liposarcoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073135 Dedifferentiated liposarcoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-001853-28 Sponsor Protocol Number: I3Y-MC-JPCP Start Date*: 2018-10-31
    Sponsor Name:Lilly S.A.
    Full Title: An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability when Receiving Abemaciclib for Patients with Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Br...
    Medical condition: Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003924-34 Sponsor Protocol Number: GETNE-1407 Start Date*: 2015-02-13
    Sponsor Name:Grupo Español de Tumores Neuroendocrinos (GETNE)
    Full Title: A phase II trial to assess the activity and safety of Palbociclib in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET).
    Medical condition: Patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068916 Pancreatic neuroendocrine tumor metastatic LLT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068909 Pancreatic neuroendocrine tumour metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003892-31 Sponsor Protocol Number: MedOPP089 Start Date*: 2017-03-23
    Sponsor Name:Medica Scientia Innovation Research (MedSIR)
    Full Title: A multicenter, international, non-controlled, phase II trial to identify the molecular mechanisms of resistance and sensitivity to palbociclib re-challenge upon progression to a palbociclib combina...
    Medical condition: Patients with hormone receptor (HR)-positive/HER2-negative locally advanced or metastatic breast cancer (mBC). Second/third-line of endocrine treatment.
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-001494-88 Sponsor Protocol Number: ET19-073 Start Date*: 2019-08-03
    Sponsor Name:Centre Léon Bérard
    Full Title: MegaMOST - A multicenter, open-label, biology driven, Phase II study evaluating the activity of anti-cancer treatments targeting tumor molecular alterations/characteristics in advanced / metastatic...
    Medical condition: all histological types of advanced / metastatic tumors with alterations molecular identified
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003543-30 Sponsor Protocol Number: EORTC-1809-STBSG Start Date*: 2020-12-16
    Sponsor Name:European Organisation for Research and Treatment of Cancer
    Full Title: A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma
    Medical condition: Primary high risk leiomyosarcoma or Liposarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073135 Dedifferentiated liposarcoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024189 Leiomyosarcoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) SK (Trial now transitioned) PL (Trial now transitioned) CZ (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) DE (Trial now transitioned) CY (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-004601-27 Sponsor Protocol Number: A5481008 Start Date*: 2013-07-17
    Sponsor Name:Pfizer Inc
    Full Title: A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2...
    Medical condition: "Estrogen receptor-positive (ER+), HER2 negative (HER2-) Advanced Breast Cancer (ABC)"
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) BE (Completed) IE (Completed) FR (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) HU (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-002392-27 Sponsor Protocol Number: A5481003 Start Date*: 2009-04-06
    Sponsor Name:Pfizer Inc.
    Full Title: PHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMEN...
    Medical condition: Advanced Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000020826 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IE (Completed) HU (Completed) DE (Completed) FR (Completed) IT (Completed) ES (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002580-26 Sponsor Protocol Number: A5481023 Start Date*: 2014-01-02
    Sponsor Name:Pfizer Inc.
    Full Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (FASLODEX) with or without PD-0332991 (PALBOCICLIB) ± Goserelin in Women with Hormone Receptor-Positive, Her2...
    Medical condition: HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE 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) NL (Completed) IE (Completed) IT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) PT (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-003353-41 Sponsor Protocol Number: 0627 Start Date*: 2018-07-05
    Sponsor Name:University of Leicester
    Full Title: Mesothelioma Stratified Therapy (MiST): A stratified multi-arm phase IIa clinical trial to enable accelerated evaluation of targeted therapies for relapsed malignant mesothelioma.
    Medical condition: Malignant Mesothelioma (MM) - pleural and peritoneal
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-003601-21 Sponsor Protocol Number: ZX-2021-FES-ESTROTIMP-4. Start Date*: 2021-09-22
    Sponsor Name:Zionexa
    Full Title: Impact of 18F-FES TEP on therapeutical management in patients with metastatic breast cancer, ER positive and HER2 negative, in relapse after a first line of treatment combining hormonal therapy
    Medical condition: Patients with metastatic breast cancer initially presenting with overexpression of estrogen receptors (ERs) and absence of overexpression of HER2, relapsing after a first therapeutic line combining...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002752-27 Sponsor Protocol Number: NCT-2014-0235/N2M2 Start Date*: 2018-04-04
    Sponsor Name:University Hospital Heidelberg
    Full Title: Umbrella protocol for phase I/IIa trials of molecularly matched targeted therapies plus radiotherapy in patients with newly diagnosed glioblastoma without MGMT promoter methylation: NCT Neuro Maste...
    Medical condition: Patient with newly diagnosed glioblastoma with unmethylated MGMT promoter
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (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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