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Last Updated: November 20, 2019

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CLINICAL TRIALS PROFILE FOR BUPARLISIB

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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 Active, not recruiting 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 Active, not recruiting 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 Recruiting 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 Recruiting 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.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Buparlisib

Condition Name

Condition Name for
Intervention Trials
Breast Cancer 3
Stage IV Non-Small Cell Lung Cancer 2
Lymphoma 2
Solid Tumors 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Carcinoma, Non-Small-Cell Lung 7
Lung Neoplasms 6
Breast Neoplasms 5
Carcinoma 4
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Clinical Trial Locations for Buparlisib

Trials by Country

Trials by Country for
Location Trials
United States 100
Italy 28
Spain 22
Canada 18
Germany 10
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Trials by US State

Trials by US State for
Location Trials
Texas 8
New York 7
Massachusetts 7
Arkansas 7
New Jersey 6
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Clinical Trial Progress for Buparlisib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 14
Phase 1/Phase 2 5
Phase 1 11
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Active, not recruiting 11
Recruiting 11
Completed 6
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Clinical Trial Sponsors for Buparlisib

Sponsor Name

Sponsor Name for
Sponsor Trials
Novartis Pharmaceuticals 17
Novartis 8
National Cancer Institute (NCI) 4
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 28
Other 24
NIH 4
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