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Showing 1–24 of 63 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: BKM120 Clear all
Completed Phase 3 Interventional Results available

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

NCT01610284
View directory record Official record
Conditions
Breast Cancer
Interventions
Fulvestrant, BKM120, BKM120 matching placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Female only
Enrollment
1,147 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2019
U.S. locations
61
States / cities
Mobile, Alabama • Phoenix, Arizona • Fayetteville, Arkansas + 51 more
Source: ClinicalTrials.gov public record
Updated Aug 24, 2020 · Synced Sep 3, 2026, 2:27 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer

NCT01132664
View directory record Official record
Conditions
Metastatic Breast Cancer, HER2+ Breast Cancer
Interventions
BKM120, Trastuzumab, Capecitabine
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
7
States / cities
Birmingham, Alabama • Fayetteville, Arkansas • Tampa, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Aug 16, 2016 · Synced Sep 3, 2026, 2:27 AM EDT
Terminated Phase 3 Interventional Results available

A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

NCT01633060
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Fulvestrant, BKM120, BKM120 matching placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Female only
Enrollment
432 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
37
States / cities
Mobile, Alabama • Chandler, Arizona • Fayetteville, Arkansas + 24 more
Source: ClinicalTrials.gov public record
Updated Jan 29, 2019 · Synced Sep 3, 2026, 2:27 AM EDT
Terminated Phase 2 Interventional Results available

LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma

NCT01820364
View directory record Official record
Conditions
Melanoma
Interventions
LGX818
Drug
Lead sponsor
Array BioPharma
Industry
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 8, 2017 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1 Interventional Results available

Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck

NCT02113878
View directory record Official record
Conditions
Carcinoma, Squamous Cell of Head and Neck, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Hypopharyngeal Cancer, Early Invasive Cervical Squamous Cell Carcinoma, Carcinoma of Larynx, Cancer of Nasopharynx
Interventions
BKM120, Cisplatin, Intensity-modulated radiotherapy (IMRT)
Drug · Radiation
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2022
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Nov 4, 2024 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1 Interventional

Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

NCT01068483
View directory record Official record
Conditions
Breast Cancer, Colon Cancer, Ovarian Cancer, Endometrium Cancer
Interventions
BKM120
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
107 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2012
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Dec 7, 2020 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 2 Interventional Results available

BKM120 for Patients With PI3K-activated Tumors

NCT01833169
View directory record Official record
Conditions
PI3K Pathway Activated Tumors
Interventions
BKM120
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
146 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
59
States / cities
Phoenix, Arizona • Sedona, Arizona • Fayetteville, Arkansas + 52 more
Source: ClinicalTrials.gov public record
Updated Oct 18, 2018 · Synced Sep 3, 2026, 2:27 AM EDT
Withdrawn Phase 1 Interventional

Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors

NCT01971489
View directory record Official record
Conditions
Adult Solid Neoplasm, Recurrent Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
Interventions
Buparlisib, Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Questionnaire Administration
Drug · Other
Lead sponsor
Roswell Park Cancer Institute
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2015
U.S. locations
1
States / cities
Buffalo, New York
Source: ClinicalTrials.gov public record
Updated Apr 26, 2023 · Synced Sep 3, 2026, 2:27 AM EDT
Terminated Phase 2 Interventional Results available

BKM120 in Metastatic Castration-resistant Prostate Cancer

NCT01385293
View directory record Official record
Conditions
Prostate Cancer, Metastatic (Spread to Other Areas of the Body)
Interventions
BKM120
Drug
Lead sponsor
Andrew J. Armstrong, MD
Other
Eligibility
18 Years and older · Male only
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
3
States / cities
Durham, North Carolina • Portland, Oregon • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated May 18, 2017 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1 Interventional

A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

NCT01473901
View directory record Official record
Conditions
Glioblastoma
Interventions
BKM120 + temozolomide, BKM120 +temozolomide with/without radiotherapy
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
3
States / cities
Fayetteville, Arkansas • Boston, Massachusetts • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Dec 8, 2020 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1 Interventional

Bevacizumab and BKM-120 in Patients With Metastatic Renal Cell Carcinoma

NCT01283048
View directory record Official record
Conditions
Renal Cell Carcinoma
Interventions
BKM-120 Bevacizumab
Drug
Lead sponsor
Toni Choueiri, MD
Other
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
3
States / cities
Boston, Massachusetts • Detroit, Michigan
Source: ClinicalTrials.gov public record
Updated Sep 20, 2016 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1Phase 2 Interventional Results available

BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma

NCT01512251
View directory record Official record
Conditions
BRAF Mutant Metastatic Melanoma
Interventions
BKM120 Combined with Vemurafenib (PLX4032)
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Aug 16, 2020 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1 Interventional

Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

NCT02088684
View directory record Official record
Conditions
Breast Cancer
Interventions
LEE011, BYL719, fulvestrant, BKM120
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Female only
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
3
States / cities
Birmingham, Alabama • Boston, Massachusetts • Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Dec 16, 2020 · Synced Sep 3, 2026, 2:27 AM EDT
Withdrawn Phase 2 Interventional

Cabazitaxel and BKM120 in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel

NCT02035124
View directory record Official record
Conditions
Advanced Prostate Cancer
Interventions
BKM 120, Cabazitaxel
Drug
Lead sponsor
SCRI Development Innovations, LLC
Other
Eligibility
18 Years and older · Male only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
3
States / cities
Fort Myers, Florida • Omaha, Nebraska • Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Feb 10, 2016 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1 Interventional

A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies

NCT01470209
View directory record Official record
Conditions
Solid Tumors, Lung Cancer
Interventions
BKM120, Everolimus
Drug
Lead sponsor
Emory University
Other
Eligibility
18 Years and older
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Mar 18, 2018 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1 Interventional

Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors

NCT01576666
View directory record Official record
Conditions
Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors, Metastatic Breast Cancer, Advanced Pancreatic Adenocarcinoma, Metastatic Colorectal Cancer, Recurrent Glioblastoma Multiforme, Gastric Cancer, Gastroesophageal Junction Cancer, Triple Negative Metastatic Breast Cancer, Hormone Receptor Positive (ER+/PR+, and Her2-) Metastatic Breast Cancer
Interventions
LDE225, BKM120
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
13
States / cities
Los Angeles, California • San Francisco, California • Tampa, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1 Interventional

PI3K Inhibitor BKM120 and Docetaxel in Treating Patients With Advanced Solid Tumor That is Locally Advanced, Cannot Be Removed By Surgery, or Metastatic

NCT01540253
View directory record Official record
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
PI3K inhibitor BKM120, docetaxel, pharmacological study, questionnaire administration, laboratory biomarker analysis
Drug · Other
Lead sponsor
Roswell Park Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
Buffalo, New York
Source: ClinicalTrials.gov public record
Updated Jul 21, 2022 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1 Interventional

A Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer

NCT01304602
View directory record Official record
Conditions
Colorectal Cancer
Interventions
Irinotecan, BKM120
Drug
Lead sponsor
University of Kansas Medical Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
1
States / cities
Kansas City, Kansas
Source: ClinicalTrials.gov public record
Updated Jan 5, 2017 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 1 Interventional

A Dose-finding Study of a Combination of Imatinib and BKM120 in the Treatment of 3rd Line GIST Patients

NCT01468688
View directory record Official record
Conditions
3rd Line GIST
Interventions
STI571, BKM120
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
2
States / cities
Boston, Massachusetts • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Dec 20, 2020 · Synced Sep 3, 2026, 2:27 AM EDT
Terminated Phase 1 Interventional

Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer

NCT01820325
View directory record Official record
Conditions
Non-Small Cell Lunch Cancer
Interventions
Buparlisib, Buparlisib placebo, Carboplatin, Paclitaxel
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Female only
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
2
States / cities
Fayetteville, Arkansas • Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Oct 10, 2018 · Synced Sep 3, 2026, 2:27 AM EDT
Terminated Phase 1 Interventional

Buparlisib and Ofatumumab or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT02614508
View directory record Official record
Conditions
Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma
Interventions
Buparlisib, Ibrutinib, Ofatumumab
Drug · Biological
Lead sponsor
Emory University
Other
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Sep 2, 2019 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Early Phase 1 Interventional

Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

NCT01719250
View directory record Official record
Conditions
Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma, Transformed Recurrent Non-Hodgkin Lymphoma
Interventions
Buparlisib, Laboratory Biomarker Analysis, Questionnaire Administration
Drug · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Oct 8, 2018 · Synced Sep 3, 2026, 2:27 AM EDT
Completed Phase 2 Interventional Results available

Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib

NCT01487265
View directory record Official record
Conditions
Non Small Cell Lung Cancer
Interventions
BKM120 and Erlotinib
Drug
Lead sponsor
SCRI Development Innovations, LLC
Other
Eligibility
18 Years and older
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
7
States / cities
Fort Myers, Florida • Orlando, Florida • St. Petersburg, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Mar 5, 2019 · Synced Sep 3, 2026, 2:27 AM EDT
Terminated Phase 2 Interventional Results available

Neoadjuvant BKM120 in High-risk Prostate Cancer

NCT01695473
View directory record Official record
Conditions
High Risk Prostate Cancer
Interventions
BKM120
Drug
Lead sponsor
Won Kim
Other
Eligibility
18 Years to 85 Years · Male only
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Jan 12, 2021 · Synced Sep 3, 2026, 2:27 AM EDT