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    DRUG:

    buparlisib (AN2025)

    i
    Company:
    Adlai Nortye, Nippon Kayaku, Novartis
    Drug class:
    PI3K inhibitor
    Related drugs:
    Apply
    Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer (NCT01300962)
    Phase 1
    UNC Lineberger Comprehensive Cancer Center
    Completed
    Last update posted :
    12/04/2023
    Initiation :
    08/01/2011
    Primary completion :
    02/07/2017
    Completion :
    12/31/2018
    HER-2
    |
    Herceptin (trastuzumab) • lapatinib • capecitabine • Piqray (alpelisib) • buparlisib (AN2025)
    P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer. (NCT01591421)
    Phase 1/2
    Canadian Cancer Trials Group
    Completed
    Last update posted :
    08/04/2023
    Initiation :
    09/06/2012
    Primary completion :
    09/30/2015
    Completion :
    11/12/2019
    KRAS • RAS
    |
    KRAS mutation • RAS mutation • RAS wild-type
    |
    Vectibix (panitumumab) • buparlisib (AN2025)
    Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors (NCT01971489)
    Phase 1
    Roswell Park Cancer Institute
    Withdrawn
    Last update posted :
    04/27/2023
    Initiation :
    09/01/2015
    Primary completion :
    08/01/2016
    PIK3CA
    |
    PIK3CA mutation
    |
    cisplatin • gemcitabine • buparlisib (AN2025)
    Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma (NCT02049541)
    Phase 1
    Kami Maddocks, MD
    Completed
    Last update posted :
    06/30/2022
    Initiation :
    07/21/2014
    Primary completion :
    09/12/2018
    Completion :
    04/09/2019
    CCND1
    |
    CCND1 overexpression
    |
    Rituxan (rituximab) • buparlisib (AN2025)
    STAR Cape+BKM120 MBC With Brain Met (NCT02000882)
    Phase 2
    US Oncology Research
    Completed
    Last update posted :
    02/07/2022
    Initiation :
    05/29/2014
    Primary completion :
    03/29/2019
    Completion :
    03/29/2019
    HER-2 • ER • PGR
    |
    HER-2 positive • HER-2 negative • ER negative
    |
    Herceptin (trastuzumab) • capecitabine • buparlisib (AN2025)
    PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (NCT01816984)
    Phase 1/2
    University of Chicago
    Completed
    Last update posted :
    10/05/2021
    Initiation :
    05/01/2013
    Primary completion :
    04/01/2018
    Completion :
    09/01/2020
    EGFR
    |
    Erbitux (cetuximab) • cisplatin • buparlisib (AN2025)
    Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer (NCT01623349)
    Phase 1
    Dana-Farber Cancer Institute
    Completed
    Last update posted :
    02/10/2021
    Initiation :
    09/01/2012
    Primary completion :
    05/01/2019
    Completion :
    12/01/2020
    BRCA1 • BRCA
    |
    BRCA2 mutation • BRCA1 mutation • BRCA1 mutation + BRCA2 mutation
    |
    Lynparza (olaparib) • Piqray (alpelisib) • buparlisib (AN2025)
    Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer. (LeeBLet) (NCT02154776)
    Phase 1
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    12/19/2020
    Initiation :
    06/27/2014
    Primary completion :
    10/26/2016
    Completion :
    10/26/2016
    HER-2 • ER • PGR
    |
    ER positive • HER-2 negative • PGR positive
    |
    Kisqali (ribociclib) • letrozole • buparlisib (AN2025)
    Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors (NCT01576666)
    Phase 1
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    12/19/2020
    Initiation :
    07/01/2012
    Primary completion :
    04/01/2015
    Completion :
    04/01/2015
    HER-2 • PGR
    |
    HR positive
    |
    buparlisib (AN2025) • Odomzo (sonidegib)
    Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer (NCT02088684)
    Phase 1
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    12/17/2020
    Initiation :
    05/19/2014
    Primary completion :
    04/17/2018
    Completion :
    04/17/2018
    HER-2
    |
    HR positive • HER-2 negative
    |
    Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • buparlisib (AN2025)
    A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients (NCT01155453)
    Phase 1
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    12/09/2020
    Initiation :
    04/01/2010
    Primary completion :
    11/01/2014
    Completion :
    11/01/2014
    BRAF
    |
    Mekinist (trametinib) • buparlisib (AN2025)
    A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab (NCT01285466)
    Phase 1
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    12/09/2020
    Initiation :
    01/01/2011
    Primary completion :
    10/01/2014
    Completion :
    10/01/2014
    HER-2
    |
    Herceptin (trastuzumab) • paclitaxel • dactolisib (RTB101) • buparlisib (AN2025)
    A Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer (SOLTI-1103) (NCT01629615)
    Phase 2
    SOLTI Breast Cancer Research Group
    Completed
    Last update posted :
    10/28/2020
    Initiation :
    06/01/2012
    Primary completion :
    10/01/2015
    Completion :
    10/01/2015
    HER-2 • ER • PGR
    |
    HER-2 negative • ER negative
    |
    buparlisib (AN2025)
    Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients (NCT01363232)
    Phase 1
    Array Biopharma, now a wholly owned subsidiary ...
    Completed
    Last update posted :
    10/05/2020
    Initiation :
    08/01/2011
    Primary completion :
    03/01/2014
    Completion :
    12/18/2017
    BRAF
    |
    Mektovi (binimetinib) • buparlisib (AN2025)
    Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor (BELLE-2) (NCT01610284)
    Phase 3
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    08/25/2020
    Initiation :
    08/07/2012
    Primary completion :
    04/29/2015
    Completion :
    04/19/2019
    HER-2 • PI3K
    |
    HR positive • HER-2 negative
    |
    fulvestrant • buparlisib (AN2025)
    BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma (NCT01512251)
    Phase 1/2
    University of California, San Francisco
    Completed
    Last update posted :
    08/17/2020
    Initiation :
    06/09/2012
    Primary completion :
    12/13/2013
    Completion :
    03/21/2017
    PTEN
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    Zelboraf (vemurafenib) • buparlisib (AN2025)
    A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer (B-YOND) (NCT02058381)
    Phase 1
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    03/09/2020
    Initiation :
    05/06/2014
    Primary completion :
    06/19/2018
    Completion :
    06/19/2018
    HER-2 • ER • PGR
    |
    ER positive • HR positive • HER-2 negative • PGR positive
    |
    tamoxifen • Piqray (alpelisib) • buparlisib (AN2025) • goserelin acetate
    NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer (NCT01816594)
    Phase 2
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    11/14/2019
    Initiation :
    09/03/2013
    Primary completion :
    02/18/2015
    Completion :
    02/18/2015
    HER-2 • ER • PIK3CA
    |
    HER-2 positive • PIK3CA mutation • ER negative • PIK3CA wild-type
    |
    Herceptin (trastuzumab) • paclitaxel • buparlisib (AN2025)
    Activity and Safety Study of BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive (PIK-ORL) (NCT01737450)
    Phase 2
    Centre Leon Berard
    Completed
    Last update posted :
    06/24/2019
    Initiation :
    01/01/2013
    Primary completion :
    09/01/2018
    Completion :
    03/01/2019
    PIK3CA
    |
    PIK3CA mutation
    |
    Erbitux (cetuximab) • buparlisib (AN2025)
    Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma (NCT01339052)
    Phase 2
    Patrick Y. Wen, MD
    Completed
    Last update posted :
    03/19/2019
    Initiation :
    09/01/2011
    Primary completion :
    10/01/2016
    Completion :
    02/01/2019
    PIK3CA • PTEN • PIK3R1
    |
    PIK3CA mutation • PTEN deletion • PTEN mutation
    |
    buparlisib (AN2025)
    Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women (NCT01923168)
    Phase 2
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    09/14/2018
    Initiation :
    03/11/2014
    Primary completion :
    07/07/2017
    Completion :
    07/08/2017
    HER-2 • ER • PIK3CA
    |
    HER-2 negative • PIK3CA mutation • PIK3CA wild-type
    |
    Piqray (alpelisib) • letrozole • buparlisib (AN2025)
    Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer (PIKTAM) (NCT02404844)
    Phase 2
    University Hospital, Essen
    Completed
    Last update posted :
    04/20/2018
    Initiation :
    12/01/2014
    Primary completion :
    09/19/2017
    Completion :
    10/19/2017
    HER-2 • ER • PGR
    |
    HR positive • HER-2 negative • PGR positive
    |
    tamoxifen • buparlisib (AN2025)
    BKM120 + Carboplatin + Paclitaxel for Patients With Advanced Solid Tumors (NCT01297452)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Completed
    Last update posted :
    03/31/2017
    Initiation :
    02/15/2011
    Primary completion :
    03/29/2017
    Completion :
    03/29/2017
    PTEN
    |
    PTEN deletion • PTEN mutation
    |
    carboplatin • paclitaxel • buparlisib (AN2025)
    Safety and Efficacy of BKM120 and Lapatinib in HER2+/PI3K-activated, Trastuzumab-resistant Advanced Breast Cancer (PIKHER2) (NCT01589861)
    Phase 1/2
    Institut Paoli-Calmettes
    Suspended
    Last update posted :
    03/28/2017
    Initiation :
    12/01/2011
    Primary completion :
    01/01/2018
    Completion :
    01/01/2018
    HER-2 • PIK3CA • PTEN
    |
    HER-2 positive • PIK3CA mutation • PTEN mutation • AKT1 overexpression • PIK3CA expression • PIK3CA overexpression • PTEN negative
    |
    Herceptin (trastuzumab) • lapatinib • buparlisib (AN2025)
    A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation (BELLE-4) (NCT01572727)
    Phase 2/3
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    03/09/2017
    Initiation :
    08/01/2012
    Primary completion :
    06/01/2015
    Completion :
    06/01/2015
    HER-2 • PI3K
    |
    HER-2 negative
    |
    paclitaxel • buparlisib (AN2025)
    BKM120 and Fulvestrant for Treating Postmenopausal Patients With Estrogen Receptor-Positive Stage IV Breast Cancer (NCT01339442)
    Phase 1
    Washington University School of Medicine
    Completed
    Last update posted :
    01/25/2017
    Initiation :
    11/14/2011
    Primary completion :
    12/21/2016
    Completion :
    12/28/2016
    ER • PIK3CA • CCND1 • CASP3 • FOXO3
    |
    PIK3CA mutation
    |
    fulvestrant • buparlisib (AN2025)
    PI3K Inhibitor BKM120, Carboplatin, and Pemetrexed Disodium in Treating Patients With Stage IV Non-Small Cell Lung Cancer (NCT01723800)
    Phase 1
    City of Hope Medical Center
    Completed
    Last update posted :
    09/20/2016
    Initiation :
    07/01/2013
    Primary completion :
    09/01/2016
    Completion :
    09/01/2016
    ALK
    |
    carboplatin • pemetrexed • buparlisib (AN2025)
    PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer (NCT01248494)
    Phase 1
    Vanderbilt-Ingram Cancer Center
    Completed
    Last update posted :
    07/25/2016
    Initiation :
    11/01/2010
    Primary completion :
    12/01/2012
    Completion :
    05/01/2016
    HER-2 • ER • PGR
    |
    ER positive • HER-2 overexpression
    |
    dactolisib (RTB101) • letrozole • buparlisib (AN2025)
    BKM120 in Cancers With PIK3CA Activating Mutations (NCT01501604)
    Phase 2
    Massachusetts General Hospital
    Withdrawn
    Last update posted :
    09/17/2015
    Initiation :
    01/01/2012
    Primary completion :
    08/01/2013
    Completion :
    08/01/2013
    PIK3CA
    |
    PIK3CA mutation
    |
    buparlisib (AN2025)