Drugs / Buparlisib
last change Nov 2025 re-read 2 minutes ago

Buparlisib

Small molecule

Developed for
breast cancer · non-small cell lung carcinoma · colorectal cancer · endometrial cancer · glioblastoma · cancer · cancer of unknown primary site · mantle cell lymphoma
+64 more · melanoma · ovarian cancer · prostate cancer · diffuse large B-cell lymphoma · female breast carcinoma · head and neck squamous cell carcinoma · HER2 positive breast carcinoma · lung cancer · metastatic prostate carcinoma · oropharynx squamous cell carcinoma · B-cell chronic lymphocytic leukemia · B-cell non-Hodgkin lymphoma · basal cell carcinoma · breast carcinoma · breast neoplasm · castration-resistant prostate carcinoma · central nervous system non-hodgkin lymphoma · cervical squamous cell carcinoma · cholangiocarcinoma · chronic lymphocytic leukemia/small lymphocytic lymphoma · colon carcinoma · esophageal cancer · estrogen-receptor positive breast cancer · follicular lymphoma · gastric cancer · gastroesophageal cancer · gastrointestinal stromal tumor · head and neck neoplasm · high grade astrocytic tumor · hormone receptor-positive breast cancer · hypopharynx cancer · hypopharynx squamous cell carcinoma · laryngeal carcinoma · larynx verrucous carcinoma · leukemia · malignant pancreatic neoplasm · MALT lymphoma · metastatic malignant neoplasm · metastatic malignant neoplasm in the brain · metastatic neoplasm · metastatic squamous cell carcinoma · myelofibrosis · nasal cavity and paranasal sinus squamous cell carcinoma · nasopharyngeal carcinoma · nasopharyngeal squamous cell carcinoma · neoplasm · nodal marginal zone B-cell lymphoma · non-small cell squamous lung carcinoma · pancreatic adenocarcinoma · renal cell carcinoma · salivary gland squamous cell carcinoma · secondary malignant neoplasm · skin cancer · small cell lung carcinoma · splenic marginal zone lymphoma · squamous cell carcinoma · thymoma · thyroid cancer · tongue cancer · transitional cell carcinoma · triple-negative breast carcinoma · verrucous carcinoma of oral cavity · Waldenstrom macroglobulinemia · head and neck cancer
Investigated by
Novartis Pharmaceuticals · Novartis · Dana-Farber Cancer Institute · Memorial Sloan Kettering Cancer Center · National Cancer Institute (NCI) · SCRI Development Innovations, LLC
+56 more · Canadian Cancer Trials Group · Emory University · Institut Paoli-Calmettes · M.D. Anderson Cancer Center · Massachusetts General Hospital · Pfizer · Roswell Park Cancer Institute · SOLTI Breast Cancer Research Group · UNC Lineberger Comprehensive Cancer Center · University of California, San Francisco · University of Utah · Washington University School of Medicine · ARCAGY/ GINECO GROUP · Adlai Nortye Biopharma Co., Ltd. · Andrew J. Armstrong, MD · Anne Chang · Array BioPharma · AstraZeneca · Beth Israel Deaconess Medical Center · Breast International Group · Brigham and Women's Hospital · Cancer Research UK · Centre Leon Berard · City of Hope Medical Center · Fondation ARC · Fondazione Michelangelo · GBG Forschungs GmbH · Hospices Civils de Lyon · Incyte Corporation · Janssen Scientific Affairs, LLC · Kami Maddocks, MD · Mayo Clinic · National Cancer Centre, Singapore · National Cancer Institute, France · Patrick Joseph Loehrer Sr. · Patrick Y. Wen, MD · Prince of Songkla University · Rutgers Cancer Institute of New Jersey · Rutgers, The State University of New Jersey · Sai Life Sciences · Sofia Perea, Director Clinical Trials Unit. · Stand Up To Cancer · Toni Choueiri, MD · US Oncology Research · University Hospital Dresden · University Hospital Tuebingen · University Hospital, Essen · University of California, Davis · University of California, Los Angeles · University of Chicago · University of Kansas Medical Center · University of Oxford · Vanderbilt-Ingram Cancer Center · Won Kim · Yonsei University · iOMEDICO AG

Trials 88 · started per year

today
1
1
3
17
24
13
20
6
2
1
2009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT01719250 Dec 2012 → Sep 2016 diffuse large B-cell lymphoma, mantle cell lymphoma Mayo Clinic Completed No outcome recorded
Phase 0 NCT01513356 Oct 2012 → Feb 2014 breast cancer Sofia Perea, Director Clinical Trials Unit. Completed No outcome recorded
Phase 144 trials
Phase 1 NCT04975958 Sep 2021 → Jan 2025 Adlai Nortye Biopharma Co., Ltd. Completed No outcome recorded
Phase 1 NCT02756247 May 2016 → Oct 2022 diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1 NCT02614508 Jan 2016 → Aug 2019 chronic lymphocytic leukemia/small lymphocytic lymphoma Emory University Terminated No outcome recorded
Phase 1 NCT01971489 Sep 2015 → Aug 2016 non-small cell lung carcinoma Roswell Park Cancer Institute Withdrawn No outcome recorded
Phase 1 NCT02117817 Feb 2015 endometrial cancer, ovarian cancer Rutgers, The State University of New Jersey Withdrawn No outcome recorded
Phase 1 NCT02487823 Oct 2014 → Nov 2017 metastatic prostate carcinoma Institut Paoli-Calmettes Terminated No outcome recorded
Phase 1 NCT02113878 Sep 2014 → Dec 2019 cervical squamous cell carcinoma, hypopharynx cancer, laryngeal carcinoma, nasopharyngeal carcinoma +1 Dana-Farber Cancer Institute Completed No outcome recorded
Phase 1 NCT02049541 Jul 2014 → Sep 2018 MALT lymphoma, Waldenstrom macroglobulinemia, mantle cell lymphoma, nodal marginal zone B-cell lymphoma +1 Kami Maddocks, MD Completed No outcome recorded
Phase 1 NCT02194049 Jul 2014 → Apr 2016 small cell lung carcinoma University of California, Davis Completed No outcome recorded
Phase 1 NCT02154776 Jun 2014 → Oct 2016 breast cancer Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/27 trials
Phase 1/2 NCT01870726 Jan 2014 → Dec 2016 high grade astrocytic tumor Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1/2 NCT01816984 May 2013 → Apr 2018 cancer of unknown primary site, hypopharynx squamous cell carcinoma, larynx verrucous carcinoma, metastatic squamous cell carcinoma +6 University of Chicago Completed No outcome recorded
Phase 1/2 NCT01591421 Sep 2012 → Sep 2015 colorectal cancer Canadian Cancer Trials Group Completed No outcome recorded
Phase 1/2 NCT01512251 Jun 2012 → Dec 2013 melanoma University of California, San Francisco Completed No outcome recorded
Phase 1/2 NCT01349660 Dec 2011 → Dec 2016 glioblastoma SCRI Development Innovations, LLC Completed No outcome recorded
Phase 1/2 NCT01589861 Dec 2011 → Oct 2017 breast cancer Institut Paoli-Calmettes Terminated No outcome recorded
Phase 1/2 NCT01132664 May 2010 → Aug 2014 HER2 positive breast carcinoma, secondary malignant neoplasm Novartis Pharmaceuticals Terminated No outcome recorded
Phase 232 trials
Phase 2 NCT01613677 Nov 2015 → Sep 2017 Novartis Pharmaceuticals Withdrawn No outcome recorded
Phase 2 NCT02452294 Jul 2015 → Dec 2017 melanoma, metastatic neoplasm University Hospital Tuebingen Unknown No outcome recorded
Phase 2 NCT02340780 Apr 2015 → Nov 2018 B-cell chronic lymphocytic leukemia Canadian Cancer Trials Group Completed No outcome recorded
Phase 2 NCT02303041 Feb 2015 → Apr 2017 basal cell carcinoma, nevoid basal cell carcinoma syndrome, skin cancer Anne Chang Terminated No outcome recorded
Phase 2 NCT02404844 Dec 2014 → Sep 2017 breast cancer University Hospital, Essen Completed No outcome recorded
Phase 2 NCT02301364 Nov 2014 → Oct 2016 central nervous system non-hodgkin lymphoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2 NCT02220855 Oct 2014 → Mar 2017 thymoma Patrick Joseph Loehrer Sr. Completed No outcome recorded
Phase 2 NCT01953445 Aug 2014 → Jun 2015 breast neoplasm Washington University School of Medicine Withdrawn No outcome recorded
Phase 2 NCT02159066 Jul 2014 → Jan 2023 melanoma Pfizer Completed No outcome recorded
Phase 2 NCT02000882 May 2014 → Mar 2019 breast cancer, metastatic malignant neoplasm in the brain US Oncology Research Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01572727 Aug 2012 → Jun 2015 female breast carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 32 trials
Phase 3 NCT01633060 Oct 2012 → May 2016 breast cancer Novartis Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT01610284 Aug 2012 → Apr 2015 breast cancer Novartis Pharmaceuticals Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT04338399 Comparator Dec 2020 → Nov 2025 head and neck cancer Adlai Nortye Biopharma Co., Ltd. Completed No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 96 sources stand behind the page.

FieldValueCited text
Known as buparlisib Buparlisib, a pan-phosphatidylinositol 3-kinase (PI3K) inhibitor, plus fulvestrant in the BELLE-2 study significantly improved progression-free survival (PFS) in patients with...” PMID 30241001 Sep 2018
28

“PURPOSE: Phosphatidylinositol 3-kinase (PI3K) signaling is highly active in glioblastomas. We assessed pharmacokinetics, pharmacodynamics, and efficacy of the pan-PI3K...” PMID 30715997 Feb 2019

“This study evaluated the combination of buparlisib, an oral phosphoinositide 3-kinase (PI3K) inhibitor, with imatinib in patients with advanced GIST, who have failed prior...” PMID 32147671 Mar 2020

“A phase 1b dose expansion study of the pan-class I PI3K inhibitor buparlisib (BKM120) plus carboplatin and paclitaxel in PTEN deficient tumors and with dose intensified...” PMID 28281183 Mar 2017

“Mouse-human co-clinical trials demonstrate superior anti-tumour effects of buparlisib (BKM120) and cetuximab combination in squamous cell carcinoma of head and neck.” PMID 32963347 Sep 2020

“PIKHER2: A phase IB study evaluating buparlisib in combination with lapatinib in trastuzumab-resistant HER2-positive advanced breast cancer.” PMID 28950146 Sep 2017

“Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer.” PMID 33138866 Nov 2020

Buparlisib (BKM120) is the investigational drug.” NCT01132664

“ribociclib plus buparlisib plus fulvestrant” PMID 32887722 Sep 2020

NCT01870726

NCT02340780

NCT02048787

NCT02756247

NCT01551030

NCT04338399

NCT02614508

NCT02058381

NCT01934361

NCT02154776

NCT02303041

NCT01719250

NCT01852292

NCT01693614

NCT02452294

NCT01923168

NCT01911325

NCT02301364

NCT01820325

NCT01971489

Known as AN2025 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04975958
Known as BKM 120 (Buparlisib) BKM 120 (Buparlisib)NCT02035124
Known as BKM-120AAA ChEMBL registry synonym — accepted as the source's own label CHEMBL2017974
Known as BKM-120NX ChEMBL registry synonym — accepted as the source's own label CHEMBL2017974
Known as BKM120 “Buparlisib (BKM120) oral once daily: 80 mg and 100 mg dose levels to be tested in the dose escalation part of the trial in combination with docetaxel every three week...” NCT01911325
71

BKM120 PO 50, 80 or 100mg every day for each day of each 21 day cycle. Number of cycles: until progression of disease; unacceptable toxicity, withdrawal or death.” NCT01300962

“The purpose of this study is to find out what effects, good and/or bad, Buparlisib (also known as BKM120) has on lymphoma and the central nervous system.” NCT02301364

“A Phase Ib, Multi-center, Open Label, Dose Escalation Study of Oral LDE225 in Combination With BKM 120 in Patients With Advanced Solid Tumors” NCT01576666

“BKM-120 is a pan-PI3K inhibitor currently tested in clinical trials.” NCT01806649

“Buparlisib (BKM120) is the investigational drug.” NCT01132664

BKM120, 100 mg PO daily” NCT01248494

“buparlisib (BKM120)” NCT02058381

“Drug: BKM 120” NCT01248494

NCT01540253

NCT01634061

NCT01512251

NCT01723800

NCT02117817

NCT02220855

NCT01591421

NCT01626209

NCT02049541

NCT01385293

NCT01339442

NCT01816984

NCT01830504

NCT01741753

NCT01513356

NCT02487823

NCT01737450

NCT02194049

NCT01727128

NCT01468688

NCT01816594

NCT01572727

NCT01397877

NCT01068483

NCT01304602

NCT01571024

NCT01613677

NCT02404844

NCT01473901

NCT01297452

NCT01695473

NCT01527877

NCT01155453

NCT01790932

NCT01363232

NCT01806649

NCT01629615

NCT01576666

NCT01833169

NCT01470209

NCT01730248

NCT01289041

NCT01339052

NCT01633060

NCT01953445

NCT01623349

NCT02035124

NCT02439489

NCT02113878

NCT01589861

NCT02128724

NCT01550380

NCT02159066

NCT01349660

NCT01487265

NCT01570296

NCT01285466

NCT01297491

NCT02000882

NCT01283503

NCT01501604

NCT01283048

NCT01396499

Known as BKM120 (IND 102823) BKM120 (IND 102823)NCT01623349
Known as Buparlisib (BKM120) Buparlisib (BKM120)NCT02439489
Known as BUPARLISIB HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL2017974
Known as NVP-BKM120 NVP-BKM120 (BKM120) is an oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor belonging to the 2,6-dimorpholino pyrimidine derivative family.” NCT01550380
Action Inhibit “clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor.” NCT01068483
Modality Small molecule “2,6-dimorpholino pyrimidine derivative family” NCT01550380
Route Oral “BKM120, Administered Orally” NCT01068483