CLINICAL TRIALS PROFILE FOR BUPARLISIB

Clinical Trials for Buparlisib

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01289041 ↗	BKM120 as Second-line Therapy for Advanced Endometrial Cancer	Completed	Novartis Pharmaceuticals	Phase 2	This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.
NCT01297491 ↗	Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer	Completed	Novartis Pharmaceuticals	Phase 2	The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.
NCT01349660 ↗	Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme	Completed	Novartis	Phase 1/Phase 2	In this phase I/II study,investigators are evaluating the feasibility and efficacy of the combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120 dose to be administered with a standard dose of bevacizumab will be determined in patients with refractory solid tumors. Although it is unlikely that the concurrent administration of bevacizumab will alter the pharmacokinetics of BKM120, limited pharmacokinetic sampling will be performed on all patients treated during the Phase II portion of the study. Assuming this combination is feasible, the Phase II portion of the study will proceed, using the doses determined in the Phase I portion. In the phase II portion, eligible patients will be limited to those with recurrent/progressive GBM following 1st line combined modality therapy.
NCT01349660 ↗	Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme	Completed	SCRI Development Innovations, LLC	Phase 1/Phase 2	In this phase I/II study,investigators are evaluating the feasibility and efficacy of the combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120 dose to be administered with a standard dose of bevacizumab will be determined in patients with refractory solid tumors. Although it is unlikely that the concurrent administration of bevacizumab will alter the pharmacokinetics of BKM120, limited pharmacokinetic sampling will be performed on all patients treated during the Phase II portion of the study. Assuming this combination is feasible, the Phase II portion of the study will proceed, using the doses determined in the Phase I portion. In the phase II portion, eligible patients will be limited to those with recurrent/progressive GBM following 1st line combined modality therapy.
NCT01470209 ↗	A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies	Completed	Novartis Pharmaceuticals	Phase 1	This study will assess the safety of combining two agents (everolimus and BKM120) for the treatment of advanced cancer arising from solid organ in patients who are no longer benefiting from or unable to withstand standard treatment of these conditions.
NCT01470209 ↗	A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies	Completed	Emory University	Phase 1	This study will assess the safety of combining two agents (everolimus and BKM120) for the treatment of advanced cancer arising from solid organ in patients who are no longer benefiting from or unable to withstand standard treatment of these conditions.

Clinical Trial Conditions for Buparlisib

Condition Name

Condition Name for
Intervention	Trials
Breast Cancer	6
Metastatic Breast Cancer	2
Solid Tumors	2
Stage IV Non-Small Cell Lung Cancer	2

Condition MeSH

Condition MeSH for
Intervention	Trials
Breast Neoplasms	9
Lung Neoplasms	7
Carcinoma, Non-Small-Cell Lung	7
Lymphoma	5

Clinical Trial Locations for Buparlisib

Trials by Country

Trials by Country for
Location	Trials
United States	172
Italy	82
Spain	50
Japan	29
Canada	27

Trials by US State

Trials by US State for
Location	Trials
Texas	12
New York	11
Massachusetts	10
Arkansas	10
California	9

Clinical Trial Progress for Buparlisib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	3
Phase 2/Phase 3	1
Phase 2	18

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	25
Terminated	8
Active, not recruiting	2

Clinical Trial Sponsors for Buparlisib

Sponsor Name

Sponsor Name for
Sponsor	Trials
Novartis Pharmaceuticals	22
Novartis	9
National Cancer Institute (NCI)	4

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	35
Other	28
NIH	4