Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL)
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|ClinicalTrials.gov Identifier: NCT02301364|
Recruitment Status : Completed
First Posted : November 25, 2014
Results First Posted : October 19, 2017
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Primary Central Nervous System Lymphoma Recurrent/Refractory Secondary Central Nervous System Lymphoma||Drug: Buparlisib (BKM120)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Of Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL)|
|Study Start Date :||November 20, 2014|
|Actual Primary Completion Date :||October 11, 2016|
|Actual Study Completion Date :||October 11, 2016|
Experimental: Buparlisib (BKM120)
This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
Drug: Buparlisib (BKM120)
Buparlisib 100 mg once daily.
- Progression Free Survival [ Time Frame: 2 years ]Progression-free survival (PFS) is defined as the time from the date of treatment start to the date of the first documented PD or death due to any cause. PFS will be based on the investigator's assessment of MRI, CSF studies and clinical presentation.
- Number of Participants With Adverse Events [ Time Frame: 2 years ]Adverse events be summarized based on the Common Toxicity Criteria version 4.0.
- Overall Survival [ Time Frame: 2 years ]Overall survival time is defined as the time from treatment start to the date of death due to any cause.
- Overall Response Rate [ Time Frame: 2 years ]This study will use the Macdonald criteria. Specific lesions must be evaluated serially, and comparative analysis of changes in the area of contrast enhancement, as well as the non-enhancing component, should be performed. Complete Response: Complete disappearance of all measurable and non-measurable disease. No new lesions. Partial Response: Great than or equal to 50% decrease over the baseline in the sum of products of perpendicular diameters of all measurable lesions. no progression of non-measurable disease. No new lesions. Stable/No Response: Does not qualify for CT, PR, or progression. Progressive Disease: 25% increase in the sum of products of all measureable lesions over smallest sum observes (or baseline if no decrease), OR clear clinical worsening of any non-measurable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301364
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering West Harrison|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Christian Grommes, MD||Memorial Sloan Kettering Cancer Center|