10 completed, 4 terminated, 1 withdrawn. 15 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 15 | Completed 10, Terminated 4, Withdrawn 1 |
| Phase 2 | 2 | Completed 1, Terminated 1 |
Follow Buparlisib: new trials by email Literature Review of Buparlisib trials Research Report on Buparlisib
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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Cisplatin, Gemcitabine Hydrochloride - Adult Solid Neoplasm, Recurrent Non-Small Cell Lung Carcinoma | Phase 1 | Withdrawn | Roswell Park Cancer Institute | 2015-09-01 | 2023-04-27 | |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 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 |
| 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 |
| Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment. Buparlisib - Renal Impairment | Phase 1 | Completed | Novartis Pharmaceuticals | 19 | 2014-03-01 | 2020-12-09 |
| Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme buparlisib, carboplatin, lomustine - Recurrent Glioblastoma Multiforme | Phase 1 | Completed | Novartis Pharmaceuticals | 35 | 2014-02-28 | 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 |
| Phase II Study of Buparlisib + Docetaxel in Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) Patients Buparlisib, Buparlisib matching placebo, Docetaxel - Squamous Non-small Cell Lung Cancer | Phase 1 | Terminated | Novartis Pharmaceuticals | 27 | 2013-10-01 | 2018-08-14 |
| Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer Buparlisib, Buparlisib placebo, Carboplatin - Non-Small Cell Lunch Cancer | Phase 1 | Terminated | Novartis Pharmaceuticals | 6 | 2013-09-09 | 2018-10-11 |
| PI3K Inhibitor BKM120, Carboplatin, and Pemetrexed Disodium in Treating Patients With Stage IV Non-Small Cell Lung Cancer PI3K inhibitor BKM120, pemetrexed disodium, carboplatin - Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer | Phase 1 | Completed | City of Hope Medical Center | 9 | 2013-07-01 | 2016-09-20 |
| Palliative Thoracic Radiotherapy Plus BKM120 BKM120 - Carcinoma, Non-Small-Cell Lung | Phase 1 | Completed | University of Oxford | 21 | 2013-04-01 | 2019-08-01 |
| BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer BKM120, mFOLFOX6 - Advanced Solid Tumors, Metastatic Colorectal Cancer | Phase 1 | Completed | UNC Lineberger Comprehensive Cancer Center | 17 | 2012-05-01 | 2017-04-26 |
| A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies BKM120, Everolimus - Solid Tumors, Lung Cancer | Phase 1 | Completed | Emory University | 43 | 2012-01-01 | 2018-03-19 |
| Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme Bevacizumab, BKM120 - Glioblastoma Multiforme | Phase 1 / Phase 2 | Completed | SCRI Development Innovations, LLC | 88 | 2011-12-01 | 2020-06-17 |
Carcinoma, Non-Small-Cell Lung (3) · Glioblastoma (3) · Lung Neoplasms (2) · Neoplasm Metastasis (2) · Brain Neoplasms (1) · Breast Neoplasms (1) · Colorectal Neoplasms (1) · Gliosarcoma (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Hypopharyngeal Neoplasms (1) · Hypoxia (1) · Laryngeal Neoplasms (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Lymphoma (1) · Lymphoma, Follicular (1)
Novartis Pharmaceuticals (6) · Emory University (2) · City of Hope Medical Center (1) · Dana-Farber Cancer Institute (1) · Memorial Sloan Kettering Cancer Center (1) · Roswell Park Cancer Institute (1) · SCRI Development Innovations, LLC (1) · UNC Lineberger Comprehensive Cancer Center (1) · University of Oxford (1)
United States (13) · Spain (5) · Germany (4) · Belgium (2) · Canada (2) · France (2) · Italy (2) · Australia (1) · Bulgaria (1) · Czechia (1) · Netherlands (1) · Romania (1) · South Korea (1) · Sweden (1) · Switzerland (1)
Alex Adjei (1) · Autumn McRee, MD (1) · Connie Batlevi, MD, PhD (1) · Geoff Higgins, MRCP, FRCR, D.Phil (1) · Glenn J. Hanna, MD (1) · Jonathon Cohen, MD, MS (1) · Karen Reckamp (1) · Kent Shih, MD (1) · Taofeek Owonikoko, MD, PhD (1)
PMID 26098748, PMID 31776899, PMID 32665311, PMID 33004905, PMID 34615723