61 completed, 15 terminated, 7 withdrawn, 3 unknown. 48 Phase 1, 39 Phase 2, 4 Phase 3, 2 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 48 | Completed 37, Terminated 9, Withdrawn 2 |
| Phase 2 | 39 | Completed 23, Terminated 8, Withdrawn 5, Unknown 3 |
| Phase 3 | 4 | Completed 3, Terminated 1 |
| Early Phase 1 | 2 | Completed 2 |
Follow NVP-BKM120: new trials by email Literature Review of NVP-BKM120 trials Research Report on NVP-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 |
| The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC Buparlisib & Paclitaxel - Head and Neck Cancer | Phase 3 | Completed | Adlai Nortye Biopharma Co., Ltd. | 487 | 2020-12-12 | 2025-11-17 |
| A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma Buparlisib, Ibrutinib - Lymphoma, Mantle Cell Lymphoma | Phase 1 | Completed | Memorial Sloan Kettering Cancer Center | 37 | 2016-05-09 | 2022-10-10 |
| 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or Locally Advanced Cervical Cancer BKM120 - Treatment for Metastatic or Locally Advanced Cervical Cancer | Phase 2 | Withdrawn | Novartis Pharmaceuticals | 2015-11-01 | 2017-04-20 | |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Cisplatin, Gemcitabine Hydrochloride - Adult Solid Neoplasm, Recurrent Non-Small Cell Lung Carcinoma | Phase 1 | Withdrawn | Roswell Park Cancer Institute | 2015-09-01 | 2023-04-27 | |
| Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER) Buparlisib - Malignant Melanoma, Metastases | Phase 2 | Unknown | University Hospital Tuebingen | 22 | 2015-07-01 | 2017-05-03 |
| Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia Buparlisib - Chronic Lymphocytic Leukemia | Phase 2 | Completed | Canadian Cancer Trials Group | 14 | 2015-04-27 | 2023-08-22 |
| 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 |
| Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) Buparlisib (BKM120) - Lymphoma, Primary Central Nervous System Lymphoma | Phase 2 | Completed | Memorial Sloan Kettering Cancer Center | 4 | 2014-11-20 | 2017-10-19 |
| 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 |
| Dose Finding Study of BKM 120 in Combination With LH-RH Agonists and Bicalutamide in Men With Non Castrate Metastatic Prostate Cancer BKM120 in combination with LH-RH agonists (suprefact) and bicalutamide - Non Castrate Metastatic Prostate Cancer | Phase 1 | Terminated | Institut Paoli-Calmettes | 6 | 2014-10-01 | 2017-11-17 |
| 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 | 2024-11-05 |
| 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 |
| Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer. LEE011, Buparlisib, Letrozole - Advanced or Metastatic Breast Cancer | Phase 1 | Completed | Novartis Pharmaceuticals | 13 | 2014-06-27 | 2020-12-19 |
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Breast Neoplasms (22) · Neoplasm Metastasis (15) · Carcinoma, Non-Small-Cell Lung (7) · Glioblastoma (6) · Colorectal Neoplasms (5) · Brain Neoplasms (4) · Endometrial Neoplasms (4) · Lymphoma, Follicular (4) · Lymphoma, Mantle-Cell (4) · Ovarian Neoplasms (4) · Recurrence (4) · Triple Negative Breast Neoplasms (4) · Head and Neck Neoplasms (3) · Hereditary Sensory and Autonomic Neuropathies (3) · Lung Neoplasms (3)
Novartis Pharmaceuticals (31) · Dana-Farber Cancer Institute (4) · Memorial Sloan Kettering Cancer Center (4) · SCRI Development Innovations, LLC (3) · Adlai Nortye Biopharma Co., Ltd. (2) · Canadian Cancer Trials Group (2) · Emory University (2) · Institut Paoli-Calmettes (2) · Roswell Park Cancer Institute (2) · Washington University School of Medicine (2) · ARCAGY/ GINECO GROUP (1) · Andrew J. Armstrong, MD (1) · Anne Chang (1) · Array Biopharma, now a wholly owned subsidiary of Pfizer (1) · Centre Leon Berard (1)
United States (59) · Spain (29) · Germany (22) · Canada (20) · France (20) · Italy (17) · Belgium (16) · United Kingdom (14) · Australia (12) · Netherlands (11) · South Korea (10) · Japan (9) · Singapore (8) · Switzerland (7) · Taiwan (7)
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) · Christian Grommes, MD (1) · Connie Batlevi, MD, PhD (1) · Cynthia Ma (1) · Daniel SW Tan, BSc, MRCP (1) · Darlene Gibbon, MD (1)
PMID 26098748, PMID 33138866, PMID 25672916, PMID 26766736, PMID 28131786, PMID 28281183, PMID 28576675, PMID 28923573, PMID 28950146, PMID 28971900, PMID 29175429, PMID 29223745, PMID 30105951, PMID 30241001, PMID 30715997, PMID 30723140, PMID 30880072, PMID 31395751, PMID 31506897, PMID 31776899, PMID 32147671, PMID 32154751, PMID 32164626, PMID 32661186, PMID 32665311, PMID 32718997, PMID 32887722, PMID 32963347, PMID 33004905, PMID 34376578, PMID 34615723, PMID 35110417, PMID 35149538, PMID 36330484, PMID 37317993, PMID 39808408, PMID 41914670
2009 (2), 2008 (1), 2014 (1), P30CA015083 (1)