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Clinical trials for Buparlisib

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 ).  
     
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    15 result(s) found for: Buparlisib. Displaying page 1 of 1.
    EudraCT Number: 2013-000699-14 Sponsor Protocol Number: CINC280X2204 Start Date*: 2014-02-26
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase Ib/II, open-label, multicenter study of INC280 in combination with buparlisib in adult patients with recurrent glioblastoma
    Medical condition: Glioblastoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) ES (Completed)
    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: 2013-003306-45 Sponsor Protocol Number: CBKM120ZDE01T Start Date*: 2015-03-24
    Sponsor Name:Universitätsklinikum Tübingen
    Full Title: An open-label, uncontrolled, single arm phase II trial of BKM120 (Buparlisib) in patients with metastatic melanoma with brain metastases not eligible for surgery or radiosurgery
    Medical condition: metastatic melanoma with brain metastases
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003103-27 Sponsor Protocol Number: UoL001152 Start Date*: 2017-01-19
    Sponsor Name:University of Liverpool
    Full Title: A proof of concept phase II study of Buparlisib in HER2 positive breast cancer with brain metastasis following HER2 directed monoclonal antibody therapy
    Medical condition: HER2-positive breast cancer with brain metastasis
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-000790-23 Sponsor Protocol Number: AN2025H0301 Start Date*: 2021-09-27
    Sponsor Name:Adlai Nortye USA Inc.
    Full Title: The BURAN Study of Buparlisib (AN2025) In Combination with Paclitaxel Compared to Paclitaxel Alone, in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
    Medical condition: Head and Neck Squamous Cell Carcinoma (HNSCC)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Ongoing) HU (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-000833-11 Sponsor Protocol Number: CBKM120D2205 Start Date*: 2013-07-11
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase Ib/II study of docetaxel with or without buparlisib as second line therapy for patients with advanced or metastatic squamous non-small cell lung cancer
    Medical condition: advanced/metastatic squamous non small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001254 Adenosquamous cell lung cancer stage IV PT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001253 Adenosquamous cell lung cancer stage IIIB LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) IT (Completed) DE (Completed) ES (Completed) GB (Completed) BE (Completed) HU (Prematurely Ended) NO (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-000744-26 Sponsor Protocol Number: CBKM120H2201 Start Date*: 2013-08-28
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Phase II multicenter randomized, double blind, placebo controlled study assessing the efficacy of buparlisib (BKM120) plus paclitaxel vs. placebo plus paclitaxel in patients with platinum pre-treat...
    Medical condition: recurrent or metastatic head and neck cancer squamous cell carcinoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067821 Head and neck cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) ES (Completed) IT (Prematurely Ended) GB (Prematurely Ended) DE (Prematurely Ended) IE (Prematurely Ended) PL (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001862-41 Sponsor Protocol Number: CBYL719A2201 Start Date*: 2013-11-26
    Sponsor Name:Novartis Farmacéutica , S.A.
    Full Title: A phase II randomized, double-blind placebo controlled, study of letrozole with or without BYL719 or buparlisib, for the neoadjuvant treatment of postmenopausal women with hormone receptor-positive...
    Medical condition: neoadjuvant hormone-receptor positive HER2-negative breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) IT (Completed) AT (Completed) BE (Completed) DE (Completed) NL (Completed) CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-005541-21 Sponsor Protocol Number: CBKM120D2204 Start Date*: 2013-06-20
    Sponsor Name:NOVARTIS FARMA
    Full Title: A dose-finding phase Ib study followed by a randomized, double-blind phase II study of carboplatin and paclitaxel with or without buparlisib in patients with previously untreated metastatic non-s...
    Medical condition: squamous non small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001254 Adenosquamous cell lung cancer stage IV PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001253 Adenosquamous cell lung cancer stage IIIB LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed) FR (Completed) ES (Completed) GB (Completed) CZ (Completed) BE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2014-000599-24 Sponsor Protocol Number: iOM-02282 Start Date*: 2014-12-18
    Sponsor Name:Universitätsklinikum Essen, Westdeutsches Tumorzentrum
    Full Title: Molecularly stratified parallel group phase II trial of the phosphoinositide 3-kinase (PI3K) inhibitor BKM120 in combination with tamoxifen in patients with hormone receptor-positive, HER2-negative...
    Medical condition: The study population includes patients with histologically, progressive, inoperable (locally advanced or metastatic) hormone receptor (HR)–positive, HER2-negative breast cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    19.0 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: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-000738-21 Sponsor Protocol Number: CBKM120F2203 Start Date*: 2013-07-05
    Sponsor Name:Novartis Pharma Services AG
    Full Title: NeoPHOEBE: Pi3k inhibition in Her2 OverExpressing Breast cancEr A phase II, randomized, parallel cohort, two stage, double-blind, placebo-controlled study of neoadjuvant trastuzumab versus trastuzu...
    Medical condition: HER2-positive, newly diagnosed, primary breast cancer
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-002208-41 Sponsor Protocol Number: CBKM120Z2402 Start Date*: 2013-03-07
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label phase II study of BKM120 in patients with relapsed and refractory diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012822 Diffuse large B-cell lymphoma refractory PT
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10026801 Mantle cell lymphoma refractory PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Completed) BE (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: 2013-004587-65 Sponsor Protocol Number: CLEE011X2108 Start Date*: 2014-04-17
    Sponsor Name:Novartis Farma
    Full Title: A phase Ib/II study of LEE011 in combination with fulvestrant and BYL719 or BKM120 in the treatment of postmenopausal women with hormone receptor positive, HER2 negative locally recurrent or advanc...
    Medical condition: Breast Cancer Hormone receptor positive, HER2 negative
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-004552-38 Sponsor Protocol Number: CLGX818X2109 Start Date*: 2014-07-10
    Sponsor Name:Array BioPharma Inc.
    Full Title: A Phase II, Multi-center, Open-label Study of sequential LGX818/MEK162 combination followed by a Rational Combination With targeted agents After Progression, to overcome resistance in Adult Patient...
    Medical condition: Locally Advanced or Metastatic BRAF V600 Melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (Completed) ES (Completed) IT (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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