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Clinical trials for PI3K

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
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    • 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   44335   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 ).  
     
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    103 result(s) found for: PI3K. Displaying page 1 of 6.
    1  2  3  4  5  6  Next»
    EudraCT Number: 2015-002900-10 Sponsor Protocol Number: APD001 Start Date*: 2016-01-29
    Sponsor Name:UCB Celltech, UK Registered Branch of UCB Pharma SA
    Full Title: AN OPEN-LABEL EXPLORATORY STUDY OF UCB5857 IN SUBJECTS WITH ACTIVATED PHOSPHOINOSITIDE 3 KINASE (PI3K) DELTA SYNDROME (APDS)
    Medical condition: Activated PI3K delta Syndrome (APDS)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-002209-20 Sponsor Protocol Number: 2015/222/HP Start Date*: 2016-08-19
    Sponsor Name:CHU-Hôpitaux de Rouen
    Full Title: PRODIGE 50 - ASPIK : French prospective randomised double blind study on aspirin versus placebo in resected colon cancer with PI3K mutation stage III or II high risk
    Medical condition: Mutated PI3K colonic adenocarcinoma patients with surgical resection R0
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-003062-32 Sponsor Protocol Number: B1271004 Start Date*: 2011-12-20
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF THE EFFICACY OF PF-04691502 AND PF-05212384 IN PATIENTS WITH RECURRENT ENDOMETRIAL CANCER
    Medical condition: RECURRENT ENDOMETRIAL CANCER
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014736 Endometrial cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SK (Prematurely Ended) ES (Completed) PL (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-002571-34 Sponsor Protocol Number: CBKM120F2303 Start Date*: 2012-08-10
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase III randomized, double blind, placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced or metas...
    Medical condition: This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive HER2 negative locally advanced or metastatic b...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Prematurely Ended) GB (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) NO (Prematurely Ended) IT (Prematurely Ended) SE (Temporarily Halted) NL (Prematurely Ended) GR (Temporarily Halted) FI (Prematurely Ended) HU (Prematurely Ended) PL (Prematurely Ended) BE (Completed) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-004120-11 Sponsor Protocol Number: BOOG2013-06 Start Date*: 2014-03-17
    Sponsor Name:VU University Medical Center
    Full Title: PI3K pathway analysis in tumor tissue and circulating DNA to obtain further insight in the efficacy of everolimus when combined with exemestane. A side-study protocol attached to standard treatmen...
    Medical condition: Hormone receptor-positive advanced metastatic breast cancer in postmenopausal patients who have progressed on anastrozole or letrozole.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003947-51 Sponsor Protocol Number: M14POS Start Date*: 2014-10-06
    Sponsor Name:NKI-AVL
    Full Title: Phase I/prospective randomized phase II trial Of the Safety and Efficacy of tamoxifen in combination with the Isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alONe in hormone rece...
    Medical condition: Hormone receptor positive metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Temporarily Halted) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001088-38 Sponsor Protocol Number: BAY80-6946/17833 Start Date*: 2015-12-09
    Sponsor Name:Bayer AG
    Full Title: A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in p...
    Medical condition: Patients with relapsed indolent non-Hodgkin's lymphoma
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) DE (Prematurely Ended) BE (Completed) CZ (Completed) DK (Prematurely Ended) ES (Prematurely Ended) GB (Completed) FR (Completed) PL (Prematurely Ended) IE (Prematurely Ended) AT (Prematurely Ended) PT (Prematurely Ended) HU (Completed) SK (Prematurely Ended) GR (Completed) BG (Prematurely Ended) IT (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003129-27 Sponsor Protocol Number: CBKM120E2102 Start Date*: 2014-02-25
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Phase Ib/II multicenter study of buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma multiforme (GBM)
    Medical condition: recurrent glioblastoma multiform
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018337 Glioblastoma multiforme PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-005541-30 Sponsor Protocol Number: APD003 Start Date*: 2016-08-23
    Sponsor Name:UCB BioPharma SPRL
    Full Title: AN OPEN-LABEL, EXPLORATORY, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF UCB5857 IN SUBJECTS WITH ACTIVATED PHOSPHOINOSITIDE 3 KINAS...
    Medical condition: Activated PI3K delta Syndrome (APDS)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-022015-19 Sponsor Protocol Number: CBKM120C2201 Start Date*: 2011-04-26
    Sponsor Name:Novartis Farmacéutica, S.A
    Full Title: Estudio de fase II, de una sola rama, de BKM120 administrado por vía oral como tratamiento de segunda línea en pacientes con carcinoma endometrial avanzado
    Medical condition: Mujeres adultas con carcinoma endometrial avanzado cuya enfermedad ha progresado durante o después del tratamiento antineoplásico de primera línea para la enfermedad avanzada.
    Disease: Version SOC Term Classification Code Term Level
    13 10007063 Cáncer de endometrio LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Prematurely Ended) BE (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-005524-17 Sponsor Protocol Number: CBKM120F2302 Start Date*: 2012-09-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase III randomized, double-blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast ...
    Medical condition: This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive HER2 negative locally advanced or metastatic b...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Prematurely Ended) BE (Completed) DE (Prematurely Ended) AT (Prematurely Ended) NL (Completed) IT (Prematurely Ended) HU (Completed) FR (Completed) GR (Completed) CZ (Prematurely Ended) SK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-024396-12 Sponsor Protocol Number: CBEZ235C2201 Start Date*: 2011-06-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase II, single-arm study of orally administered BEZ235 as second-line therapy in patients with advanced endometrial carcinoma
    Medical condition: Patients who have experienced progression of disease after first-line antineoplasic treatment of advanced endometrial carcinoma
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014745 Endometrial carcinoma metastatic LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: CZ (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-002602-52 Sponsor Protocol Number: BAY80-6946/16349 Start Date*: 2012-10-19
    Sponsor Name:Bayer AG
    Full Title: Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY 80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas
    Medical condition: Patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas or patients with follicular lymphoma relapsed after or refractory to standard therapy.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    20.0 100000004851 10029621 Non-Hodgkin's lymphomas unspecified histology indolent HLT
    20.0 100000004851 10029608 Non-Hodgkin's lymphomas unspecified histology aggressive HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FI (Completed) DE (Completed) BE (Completed) ES (Completed) IT (Completed) SE (Completed) PL (Completed) AT (Completed) PT (Completed) HU (Completed) DK (Prematurely Ended) IE (Completed) GR (Completed) LU (Completed)
    Trial results: View results
    EudraCT Number: 2011-005932-24 Sponsor Protocol Number: CBKM120F2202 Start Date*: 2012-07-24
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, placebo controlled, phase II/III study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without ...
    Medical condition: This study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Completed) CZ (Completed) ES (Temporarily Halted) NL (Completed) GB (Completed) BE (Completed) HU (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-016862-10 Sponsor Protocol Number: XL147-203 Start Date*: 2010-06-22
    Sponsor Name:Exelixis INC.
    Full Title: A Phase 1/2 Study of XL147 Administered in Combination with Trastuzumab or Paclitaxel and Trastuzumab in Subjects with Metastatic Breast Cancer who have Progressed on a Previous Trastuzumab- Based ...
    Medical condition: Subjects with Metastatic Breast Cancer who have Progressed on a Previous Trastuzumab-Based Regimen
    Disease: Version SOC Term Classification Code Term Level
    12.1 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-002403-18 Sponsor Protocol Number: ET12-034 Start Date*: 2013-01-17
    Sponsor Name:Centre Léon Berard
    Full Title: PIK-ORL: A Phase II, multicenter trial aiming to evaluate BKM120 in monotherapy in patients with metastatic head and neck cancer recurrent or progressive under platin and cetuximab-based chemotherapy
    Medical condition: Patients with metastatic or relapsed head and neck cancer and documented progression or relapse after platin and cetuximab-based chemotherapy (combination or sequential treatment)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067821 Head and neck cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-004340-19 Sponsor Protocol Number: UC-0130/1507 Start Date*: 2016-03-01
    Sponsor Name:UNICANCER
    Full Title: Phase Ib/II trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) harboring...
    Medical condition: Recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) harboring a PI3KCA mutation/amplification and/or a PTEN loss
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-024394-39 Sponsor Protocol Number: CBEZ235B2201 Start Date*: 2011-05-06
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase II study of orally administered BEZ235 monotherapy in patients with hormone receptor positive, HER2 negative, metastatic breast cancer, with or without PI3K activated pathway
    Medical condition: Patients who have experienced progression of disease after first-line antineoplasic treatment of advanced endometrial carcinoma
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: CZ (Prematurely Ended) GB (Prematurely Ended) BE (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-024011-14 Sponsor Protocol Number: CBKM120D2201 Start Date*: 2011-06-22
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open label two-stage study of orally administered BKM120 in patients with metastatic non-small cell lung cancer with activated PI3K pathway
    Medical condition: Adult patients with metastatic NSCLC with activated PI3Kpathway.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) HU (Completed) DE (Completed) NL (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-000468-41 Sponsor Protocol Number: CCDZ173X2201E1 Start Date*: 2016-07-19
    Sponsor Name:Pharming Technologies B.V.
    Full Title: An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinos...
    Medical condition: APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) NL (Prematurely Ended) IE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) IT (Prematurely Ended)
    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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