12 completed, 4 terminated, 1 unknown. 17 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 17 | Completed 12, Terminated 4, Unknown 1 |
| Phase 1 | 2 | Completed 1, Terminated 1 |
| Phase 3 | 1 | Completed 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 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 |
| 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 |
| Neoadjuvant BKM120 in High-risk Prostate Cancer BKM120 - High Risk Prostate Cancer | Phase 2 | Terminated | Won Kim | 11 | 2013-04-23 | 2021-01-13 |
| Safety and Efficacy of BKM120 in Relapsed and Refractory NHL Buparlisib - Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma | Phase 2 | Completed | Novartis Pharmaceuticals | 72 | 2013-02-28 | 2018-09-28 |
| Activity and Safety Study of BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive BKM120 - Head and Neck Neoplasms, Neoplasm Metastasis | Phase 2 | Completed | Centre Leon Berard | 58 | 2013-01-01 | 2019-06-24 |
| A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation Paclitaxel, BKM120 matching placebo, BKM120 - Breast Cancer | Phase 2 / Phase 3 | Completed | Novartis Pharmaceuticals | 416 | 2012-08-01 | 2017-03-09 |
| BKM120 For Triple Negative Breast Cancer BKM120 - Breast Cancer | Phase 2 | Completed | Dana-Farber Cancer Institute | 50 | 2012-06-01 | 2019-01-23 |
| Buparlisib in Metastatic Transitional Cell Carcinoma of the Urothelium Buparlisib - Metastatic Transitional Cell Carcinoma of the Urothelium | Phase 2 | Completed | Memorial Sloan Kettering Cancer Center | 19 | 2012-03-01 | 2021-06-21 |
| 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 |
| Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer BKM120 - Non-small Cell Lung Cancer | Phase 2 | Completed | Novartis Pharmaceuticals | 63 | 2011-05-01 | 2016-03-11 |
| BKM120 as Second-line Therapy for Advanced Endometrial Cancer BKM120 - Advanced Endometrial Cancer | Phase 2 | Completed | Novartis Pharmaceuticals | 70 | 2011-02-01 | 2019-05-30 |
Breast Neoplasms (5) · Neoplasm Metastasis (5) · Brain Neoplasms (2) · Glioblastoma (2) · Recurrence (2) · Basal Cell Nevus Syndrome (1) · Carcinoma, Basal Cell (1) · Carcinoma, Non-Small-Cell Lung (1) · Disease Progression (1) · Gliosarcoma (1) · Head and Neck Neoplasms (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Lymphoma, Follicular (1) · Lymphoma, Large B-Cell, Diffuse (1)
Novartis Pharmaceuticals (7) · Anne Chang (1) · Canadian Cancer Trials Group (1) · Centre Leon Berard (1) · Dana-Farber Cancer Institute (1) · Memorial Sloan Kettering Cancer Center (1) · SCRI Development Innovations, LLC (1) · US Oncology Research (1) · University Hospital Tuebingen (1) · University Hospital, Essen (1) · Won Kim (1)
United States (13) · Germany (9) · Spain (7) · Canada (6) · France (6) · Italy (6) · Belgium (5) · Japan (5) · Australia (4) · Brazil (4) · Netherlands (4) · Hong Kong (3) · Hungary (3) · Russia (3) · Singapore (3)
Anja Welt, MD (1) · Anne Lynn Chang, MD (1) · Dean Bajorin, MD (1) · Joyce A. O'Shaughnessy, MD (1) · Kent Shih, MD (1) · Morris D. Groves, MD, JD (1) · Nancy Lin, MD (1) · Sarit Assouline (1) · Won Kim, MD (1)
PMID 26098748, PMID 28131786, PMID 28971900, PMID 29175429, PMID 30723140, PMID 31776899, PMID 32154751, PMID 33138866, PMID 39808408
2014 (1)