1 |
NCT02301364 |
Completed Has Results |
Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) |
- Lymphoma
- Primary Central Nervous System Lymphoma
- Recurrent/Refractory Secondary Central Nervous System Lymphoma
|
- Drug: Buparlisib (BKM120)
|
Interventional |
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- Novartis
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival
- Number of Participants With Adverse Events
- Overall Survival
- Overall Response Rate
|
4 |
All |
18 Years and older (Adult, Senior) |
NCT02301364 |
14-177 |
|
November 20, 2014 |
October 11, 2016 |
October 11, 2016 |
November 25, 2014 |
October 19, 2017 |
October 19, 2017 |
- Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States - Memorial Sloan Kettering West Harrison
Harrison, New York, United States - Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
2 |
NCT02614508 |
Active, not recruiting |
Buparlisib and Ofatumumab or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia |
- Recurrent Chronic Lymphocytic Leukemia
- Recurrent Small Lymphocytic Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Small Lymphocytic Lymphoma
|
- Drug: Buparlisib
- Drug: Ibrutinib
- Biological: Ofatumumab
|
Interventional |
Phase 1 |
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD) of buparlisib when combined with ibrutinib in relapsed/refractory CLL for ibrutinib naive patients defined as the dose level at which no more than 1 of 6 patients experiences a dose-limiting toxicity
- MTD of buparlisib when combined with ofatumumab in relapsed/refractory CLL for ibrutinib pre-treated patients defined as the dose level at which no more than 1 of 6 patients experiences a dose-limiting toxicity
- Complete response rate
- (and 5 more...)
|
1 |
All |
18 Years and older (Adult, Senior) |
NCT02614508 |
IRB00071983 NCI-2015-00652 Winship2494-13/CBKM120ZUS36T |
|
January 2016 |
September 2018 |
September 2018 |
November 25, 2015 |
October 2, 2017 |
|
- Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
|
3 |
NCT02756247 |
Active, not recruiting |
A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma |
- Lymphoma
- Mantle Cell Lymphoma
- Follicular Lymphoma
- Diffuse Large B Cell Lymphoma
|
- Drug: Buparlisib
- Drug: Ibrutinib
|
Interventional |
Phase 1 |
- Memorial Sloan Kettering Cancer Center
- Janssen Scientific Affairs, LLC
- Novartis Pharmaceuticals
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD)
|
37 |
All |
18 Years and older (Adult, Senior) |
NCT02756247 |
16-009 |
|
May 2016 |
May 2019 |
May 2019 |
April 29, 2016 |
March 1, 2018 |
|
- Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States - Memorial Sloan Kettering Commack
Commack, New York, United States - (and 3 more...)
|
4 |
NCT02340780 |
Active, not recruiting |
Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia |
- Chronic Lymphocytic Leukemia
|
|
Interventional |
Phase 2 |
- Canadian Cancer Trials Group
- Novartis
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate
- Number of adverse events in patients
- Efficacy of buparlisib (duration of response rate and progression free survival); composite outcome measure.
|
14 |
All |
18 Years and older (Adult, Senior) |
NCT02340780 |
I216 |
|
January 30, 2015 |
June 2018 |
December 2018 |
January 19, 2015 |
February 1, 2018 |
|
- Tom Baker Cancer Centre
Calgary, Alberta, Canada - Cross Cancer Institute
Edmonton, Alberta, Canada - CancerCare Manitoba
Winnipeg, Manitoba, Canada - (and 3 more...)
|
5 |
NCT01719250 |
Completed |
Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma |
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- (and 2 more...)
|
- Drug: Buparlisib
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
|
Interventional |
Not Applicable |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical benefit defined as a PR or CR as the objective status at any time or an objective status of SD for a duration of greater than 6 months from registration
- Duration of response
- Overall response rate estimated by the number of confirmed responses (PR or CR) observed in the trial divided by the total number of evaluable patients
- (and 3 more...)
|
7 |
All |
18 Years and older (Adult, Senior) |
NCT01719250 |
MC1183 NCI-2012-01582 P30CA015083 |
|
December 2012 |
September 16, 2016 |
March 22, 2017 |
November 1, 2012 |
March 27, 2017 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
6 |
NCT01693614 |
Completed |
Safety and Efficacy of BKM120 in Relapsed and Refractory NHL |
- Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
|
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response rate
- Progression-free survival
- Duration of response
- (and 2 more...)
|
72 |
All |
18 Years and older (Adult, Senior) |
NCT01693614 |
CBKM120Z2402 2012-002208-41 |
|
February 28, 2013 |
July 21, 2017 |
July 21, 2017 |
September 26, 2012 |
September 18, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States - University of Nebraska Medical Center Univ Nebraska
Omaha, Nebraska, United States - Memorial Sloan Kettering Cancer Center Dept of Onc.
New York, New York, United States - (and 17 more...)
|
7 |
NCT02049541 |
Active, not recruiting |
Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma |
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Nodal Marginal Zone B-cell Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- (and 6 more...)
|
- Drug: PI3K inhibitor BKM120
- Biological: rituximab
- Other: Pharmacodynamics
- Other: Correlative studies
|
Interventional |
Phase 1 |
- Kami Maddocks
- Novartis
- Ohio State University Comprehensive Cancer Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- MTD defined as the dose level at which no more than one of 6 patients experiences a DLT summarized using the National Cancer Institute (NCI) CTCAE version 4.0
- Incidence of grade 3 or greater adverse events summarized using the NCI CTCAE version 4.0
- Overall response rate (ORR) evaluated by computed tomography (CT) or positron emission tomography (PET)/CT
- Change in correlative markers in blood, bone marrow and tumor tissue
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT02049541 |
OSU-13027 NCI-2014-00110 |
|
July 2014 |
June 1, 2018 |
June 1, 2018 |
January 30, 2014 |
September 14, 2017 |
|
- Emory University
Atlanta, Georgia, United States - Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
|