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Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL)
Phase 2 trial testing Buparlisib (BKM120) in Lymphoma in 4 participants. Completed in 11 October 2016.
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 20 November 2014 |
| Primary completion | 11 October 2016 |
| Estimated completion | 11 October 2016 |
| Sites | 4 locations across United States |
Memorial Sloan Kettering Cancer Center — full company profile →
18 and older, any sex, with Lymphoma or Primary Central Nervous System Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Buparlisib (BKM120) | 39 | 30 – 78 |
Adverse events be summarized based on the Common Toxicity Criteria version 4.0.
| Group | Value | 95% CI |
|---|---|---|
| Buparlisib (BKM120) | 4 |
Overall survival time is defined as the time from treatment start to the date of death due to any cause.
| Group | Value | 95% CI |
|---|---|---|
| Buparlisib (BKM120) | 196 | 54 – 284 |
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. P
| Group | Value | 95% CI |
|---|---|---|
| Buparlisib (BKM120) | 1 | |
| Buparlisib (BKM120) | 3 |
Time frame: Up to 30 days post treatment. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Buparlisib (BKM120) |
|---|---|---|
| Dysphasia | Nervous system disorders | — |
| Confusion | Psychiatric disorders | — |
| Death NOS | General disorders | — |
| Depression | Psychiatric disorders | — |
| Encephalopathy | Nervous system disorders | — |
| Hallucinations | Psychiatric disorders | — |
| Infections and infestations - Other, specify | Infections and infestations | — |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Seizure | Nervous system disorders | — |
| Reaction | System | Buparlisib (BKM120) |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Platelet count decreased | Investigations | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| INR increased | Investigations | — |
| Alanine aminotransferase increased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Cognitive disturbance | Nervous system disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| White blood cell decreased | Investigations | — |
| Alkaline phosphatase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Cholesterol high | Investigations | — |
| Confusion | Psychiatric disorders | — |
| Depression | Psychiatric disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Dysphasia | Nervous system disorders | — |
| Encephalopathy | Nervous system disorders | — |
| Fatigue | General disorders | — |
| Hallucinations | Psychiatric disorders | — |
| Hypernatremia | Metabolism and nutrition disorders | — |
| Hypoglycemia | Metabolism and nutrition disorders | — |
| Lethargy | Nervous system disorders | — |
| Memory impairment | Nervous system disorders | — |
| Neutrophil count decreased | Investigations | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Seizure | Nervous system disorders | — |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | — |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | — |
Most-reported serious reactions: Dysphasia, Confusion, Death NOS, Depression, Encephalopathy, Hallucinations, Infections and infestations - Other, specify, Muscle weakness right-sided.
Data from ClinicalTrials.gov NCT02301364 adverse events section.
The purpose of this study is to find out what effects, good and/or bad, Buparlisib (also known as BKM120) has on lymphoma and the central nervous system.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing