|Exclusion Criteria:||1) Participants who have received prior treatment with a P13K inhibitor, AKT inhibitor, mTOR inhibitor (e.g. rapamycin, MK2206, perifosine etc.).|
2) Participants who have received anti-VEGF targeted agents (e.g. bevacizumab, cediranib, aflibercept, vandetanib, XL184, sunitinib etc).
3) Participants taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate. Participant must be off any EIAEDs for at least two weeks prior to starting study drug.
4) Participants taking a drug known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A. Participant must be off CYP3A inhibitors and inducers for at least two weeks prior to starting study drug. NOTE: participants must avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to the first dose of study drug and during the entire study treatment period due to potential CYP3A4 interaction.
5) Requirement of more than 8mg of dexamethasone daily.
6) Participants taking drugs with known risk to promote QT prolongation and Torsades de Pointes.
7) Participants receiving any other investigational agents.
8) Current use of herbal preparations/medications, including but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, ginseng. Participants should stop using these herbal medications 7 days prior to first dose of study drug.
9) Current use of warfarin sodium or any other coumadin-derivative anticoagulant. Participant must be off Coumadin-derivative anticoagulants for at least seven days prior to starting study drug. Low molecular weight heparin is allowed.
10) History of allergic reactions attributed to compounds of similar chemical or biologic composition to BKM120.
11) History of intratumoral or peritumoral hemorrhage if deemed significant by the treating physician. If there are questions, the treating physician should contact the study Overall principal investigator.
12) Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), chronic renal disease, pancreatitis, chronic pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects must be free of any clinically relevant disease (other than glioma) that would, in the Investigator's opinion, interfere with the conduct of the study or study evaluations.
13) Individuals with a history of a different malignancy except for the following circumstances: if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
14) Known diagnosis of human immunodeficiency virus (HIV) infection
15) Participants with the following mood disorders as judged by the Investigator or a psychiatrist, or as result of participant's mood assessment questionnaire: a. Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) b. Score of >/= 12 in the PHQ-9 c. Selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) d. Score of >/= 15 in the GAD-7 mood scale e. >/= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety. Note: If participant is ineligible due to PHQ-9 or GAD-7 scores including Q9 on PHQ-9, treating investigator is to be informed immediately and will determine appropriate actions regarding referrals.
16) Participants with diarrhea >/= CTCAE grade 2
17) Participant has active cardiac disease including any of the following: Angina pectoris that requires the use of anti-anginal medications; Ventricular arrhythmias except for benign premature ventricular contractions; Supraventricular and nodal arrythmias requiring a pacemaker or not controlled with medication; Conduction abnormality requiring a pacemaker; Valvular disease with document compromise in cardiac function; Symptomatic pericarditis.
18) Participant has a history of cardiac dysfunction including any of the following: Myocardial infraction within the last 6 months, documents by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of Left Ventricular Ejection fraction(LVEF) function; History of documents congestive heart failure (New York Heart Association functional classification III-IV); Documented cardiomyopathy; Congenital long QT syndrome.
19) Participants with poorly controlled diabetes mellitus (glycosolated hemoglobin > 8%) or poorly controlled steroid-induced diabetes mellitus (glycosolated hemoglobin > 8%)
20) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive small bowel resection). Participants with unresolved diarrhea will be excluded as previously indicated.
21) Participants who have undergone major systemic surgery </= 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.