45 completed, 13 terminated, 6 withdrawn, 2 unknown. 35 Phase 1, 32 Phase 2, 3 Phase 3, 2 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 35 | Completed 26, Terminated 7, Withdrawn 2 |
| Phase 2 | 32 | Completed 19, Terminated 7, Withdrawn 4, Unknown 2 |
| Phase 3 | 3 | Completed 2, Terminated 1 |
| Early Phase 1 | 2 | Completed 2 |
Follow BKM120: new trials by email Literature Review of BKM120 trials Research Report on BKM120
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors AN2025, AN0025, Atezolizumab 1200 mg in 20 ML Injection - Locally Advanced Solid Tumor | Phase 1 | Completed | Adlai Nortye Biopharma Co., Ltd. | 47 | 2021-09-07 | 2025-06-22 |
| Buparlisib and Ofatumumab or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Buparlisib, Ibrutinib, Ofatumumab - Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma | Phase 1 | Terminated | Emory University | 1 | 2016-01-01 | 2019-09-03 |
| Phase II, Open Label, Non-randomized, Trial of BKM120 for Metastatic or Locally Advanced Cervical Cancer BKM120 - Treatment for Metastatic or Locally Advanced Cervical Cancer | Phase 2 | Withdrawn | Novartis Pharmaceuticals | 2015-11-01 | 2017-04-20 | |
| Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors Buparlisib, Cisplatin, Gemcitabine Hydrochloride - Adult Solid Neoplasm, Recurrent Non-Small Cell Lung Carcinoma | Phase 1 | Withdrawn | Roswell Park Cancer Institute | 2015-09-01 | 2023-04-27 | |
| Phase I BKM120/Abraxane in Solid Tumors, Expansion Phase Recurrent Endometrial or Ovarian Cancer BKM120, Nabpaclitaxel - Ovarian Cancer, Endometrial Cancer | Phase 1 | Withdrawn | Rutgers, The State University of New Jersey | 2015-02-01 | 2022-07-28 | |
| Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma Buparlisib, Sonidegib - Carcinoma, Basal Cell, Recurrent Skin Cancer | Phase 2 | Terminated | Anne Chang | 10 | 2015-02-01 | 2019-01-29 |
| Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer BKM120, Tamoxifen - Breast Cancer | Phase 2 | Completed | University Hospital, Essen | 48 | 2014-12-01 | 2018-04-20 |
| A Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas BKM120 - Thymoma | Phase 2 | Completed | Patrick Joseph Loehrer Sr. | 14 | 2014-10-01 | 2022-04-11 |
| Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck BKM120, Cisplatin, Intensity-modulated radiotherapy (IMRT) - Carcinoma, Squamous Cell of Head and Neck, HPV Positive Oropharyngeal Squamous Cell Carcinoma | Phase 1 | Completed | Dana-Farber Cancer Institute | 23 | 2014-09-29 | 2026-11-05 |
| Paclitaxel and BKM120 Before Surgery in Treating Patients With Stage II or III Estrogen Receptor-Positive and HER2-Negative Breast Cancer paclitaxel, BKM120 - Breast Neoplasms | Phase 2 | Withdrawn | Washington University School of Medicine | 2014-08-01 | 2014-12-08 | |
| LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma LGX818, MEK162, LEE011 - Melanoma | Phase 2 | Completed | Pfizer | 158 | 2014-07-23 | 2024-03-05 |
| Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma PI3K inhibitor BKM120, rituximab, Pharmacodynamics - Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma | Phase 1 | Completed | Kami Maddocks, MD | 18 | 2014-07-21 | 2022-06-30 |
| Cisplatin, Etoposide and PI3K Inhibitor BKM120 in Treating Patients With Advanced Solid Tumors or Small Cell Lung Cancer BKM120, cisplatin, etoposide - Extensive Stage Small Cell Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific | Phase 1 | Completed | University of California, Davis | 3 | 2014-07-01 | 2018-01-09 |
| STAR Cape+BKM120 MBC With Brain Met BKM120, capecitabine, Trastuzumab - Brain Metastases, Breast Cancer | Phase 2 | Completed | US Oncology Research | 10 | 2014-05-29 | 2022-02-07 |
| Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer LEE011, BYL719, fulvestrant - Breast Cancer | Phase 1 | Completed | Novartis Pharmaceuticals | 70 | 2014-05-19 | 2020-12-17 |
| BKM120 in Advanced, Metastatic, or Recurrent Endometrial Cancers BKM120 - Endometrial Cancer | Phase 2 | Withdrawn | University of Utah | 2014-05-01 | 2014-07-29 | |
| Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women alpelisib, buparlisib, Placebo - Breast Cancer | Phase 2 | Completed | Novartis Pharmaceuticals | 340 | 2014-03-11 | 2018-09-14 |
| Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment. Buparlisib - Renal Impairment | Phase 1 | Completed | Novartis Pharmaceuticals | 19 | 2014-03-01 | 2020-12-09 |
| Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Glioblastoma INC280, Buparlisib - c-MET Inhibitor; PI3K Inhibitor, PTEN Mutations, Homozygous Del. of PTEN or PTEN Neg. by IHC, c-Met Ampli. by FISH, INC280, BKM120, Buparlisib; Recurrent GBM | Phase 1 / Phase 2 | Terminated | Novartis Pharmaceuticals | 43 | 2014-01-09 | 2018-05-30 |
| Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy Buparlisib, Buparlisib matching Placebo, Paclitaxel - Head and Neck Squamous Cell Carcinoma | Phase 2 | Terminated | Novartis Pharmaceuticals | 157 | 2013-10-01 | 2018-07-24 |
Showing 20 of 66. Sign in to see all of them.
Breast Neoplasms (19) · Neoplasm Metastasis (12) · Carcinoma, Non-Small-Cell Lung (5) · Colorectal Neoplasms (5) · Brain Neoplasms (4) · Endometrial Neoplasms (4) · Glioblastoma (4) · Hereditary Sensory and Autonomic Neuropathies (3) · Lung Neoplasms (3) · Lymphoma, Follicular (3) · Lymphoma, Mantle-Cell (3) · Prostatic Neoplasms (3) · Squamous Cell Carcinoma of Head and Neck (3) · Triple Negative Breast Neoplasms (3) · Esophageal Neoplasms (2)
Novartis Pharmaceuticals (26) · Dana-Farber Cancer Institute (3) · Emory University (2) · Roswell Park Cancer Institute (2) · Washington University School of Medicine (2) · ARCAGY/ GINECO GROUP (1) · Adlai Nortye Biopharma Co., Ltd. (1) · Andrew J. Armstrong, MD (1) · Anne Chang (1) · Canadian Cancer Trials Group (1) · Centre Leon Berard (1) · City of Hope Medical Center (1) · Hospices Civils de Lyon (1) · Kami Maddocks, MD (1) · L. Nicolas Gonzalez Castro, MD, PhD (1)
United States (47) · Spain (23) · Germany (18) · France (16) · Canada (15) · Italy (15) · Belgium (13) · United Kingdom (13) · Australia (9) · Netherlands (9) · Japan (8) · South Korea (8) · Austria (6) · Brazil (6) · Singapore (6)
Alex Adjei (2) · Andrew Armstrong, MD, ScM (1) · Anja Welt, MD (1) · Anne Lynn Chang, MD (1) · Arunee Dechaphunkul, MD (1) · Autumn McRee, MD (1) · Byoung Chul Cho, M.D., Ph.D. (1) · Cynthia Ma (1) · Darlene Gibbon, MD (1) · Derek Jonker (1) · Eric Winer, MD (1) · Foluso Ademuyiwa, M.D., M.P.H. (1) · Geoff Higgins, MRCP, FRCR, D.Phil (1)
PMID 26098748, PMID 33138866, PMID 26766736, PMID 28131786, PMID 28576675, PMID 28923573, PMID 28971900, PMID 29175429, PMID 29223745, PMID 30105951, PMID 30241001, PMID 30715997, PMID 30723140, PMID 31506897, PMID 31776899, PMID 32147671, PMID 32887722, PMID 32963347, PMID 33004905, PMID 34376578, PMID 36330484, PMID 39808408, PMID 41914670
2009 (2), 2008 (1), 2014 (1), P30CA015083 (1)