Trial Outcomes & Findings for Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) (NCT NCT02301364)
NCT ID: NCT02301364
Last Updated: 2017-10-19
Results Overview
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.
COMPLETED
PHASE2
4 participants
2 years
2017-10-19
Participant Flow
Protocol Open to Accrual 11/20/2014 Protocol Closed to Accrual 03/22/2/016 Primary Completion Date 10/11/2016 Recruitment Location is the medical clinic
Participant milestones
| Measure |
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).
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|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL)
Baseline characteristics by cohort
| Measure |
Buparlisib (BKM120)
n=4 Participants
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).
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsProgression-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.
Outcome measures
| Measure |
Buparlisib (BKM120)
n=4 Participants
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).
|
|---|---|
|
Progression Free Survival
|
39 days
Interval 30.0 to 78.0
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SECONDARY outcome
Timeframe: 2 yearsAdverse events be summarized based on the Common Toxicity Criteria version 4.0.
Outcome measures
| Measure |
Buparlisib (BKM120)
n=4 Participants
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).
|
|---|---|
|
Number of Participants With Adverse Events
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOverall survival time is defined as the time from treatment start to the date of death due to any cause.
Outcome measures
| Measure |
Buparlisib (BKM120)
n=4 Participants
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).
|
|---|---|
|
Overall Survival
|
196 days
Interval 54.0 to 284.0
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SECONDARY outcome
Timeframe: 2 yearsThis 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).
Outcome measures
| Measure |
Buparlisib (BKM120)
n=4 Participants
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).
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|---|---|
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Overall Response Rate
Partial Response
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1 Participants
|
|
Overall Response Rate
Progressive Disease
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3 Participants
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Adverse Events
Buparlisib (BKM120)
Serious adverse events
| Measure |
Buparlisib (BKM120)
n=4 participants at risk
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).
|
|---|---|
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Psychiatric disorders
Confusion
|
25.0%
1/4 • Up to 30 days post treatment
|
|
General disorders
Death NOS
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Nervous system disorders
Dysphasia
|
50.0%
2/4 • Up to 30 days post treatment
|
|
Nervous system disorders
Encephalopathy
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Psychiatric disorders
Hallucinations
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
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25.0%
1/4 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Nervous system disorders
Seizure
|
25.0%
1/4 • Up to 30 days post treatment
|
Other adverse events
| Measure |
Buparlisib (BKM120)
n=4 participants at risk
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).
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
100.0%
4/4 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
4/4 • Up to 30 days post treatment
|
|
Investigations
Platelet count decreased
|
100.0%
4/4 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
75.0%
3/4 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
75.0%
3/4 • Up to 30 days post treatment
|
|
Investigations
INR increased
|
75.0%
3/4 • Up to 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Up to 30 days post treatment
|
|
Investigations
Blood bilirubin increased
|
50.0%
2/4 • Up to 30 days post treatment
|
|
Nervous system disorders
Cognitive disturbance
|
50.0%
2/4 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
2/4 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
2/4 • Up to 30 days post treatment
|
|
Investigations
Lymphocyte count decreased
|
50.0%
2/4 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
2/4 • Up to 30 days post treatment
|
|
Investigations
White blood cell decreased
|
50.0%
2/4 • Up to 30 days post treatment
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Investigations
Cholesterol high
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Psychiatric disorders
Confusion
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Nervous system disorders
Dysphasia
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Nervous system disorders
Encephalopathy
|
25.0%
1/4 • Up to 30 days post treatment
|
|
General disorders
Fatigue
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Psychiatric disorders
Hallucinations
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Nervous system disorders
Lethargy
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Nervous system disorders
Memory impairment
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Nervous system disorders
Seizure
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
25.0%
1/4 • Up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
25.0%
1/4 • Up to 30 days post treatment
|
Additional Information
Christian Grommes, MD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place