Serum triglyceride level =< 300 mg/dLXx_NEWLINE_xXSerum total cholesterol level =< 300 mg/dLXx_NEWLINE_xXRandom or fasting blood glucose =< the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then follow-up fasting blood glucose can be obtained and must be =< the upper normal limits for ageXx_NEWLINE_xXGlucose < 200 mg/dlXx_NEWLINE_xXUncontrolled diabetes (if non-fasting blood sugar > 200 mg/dl, perform a fasting blood sugar which must be =< 200 mg/dl)Xx_NEWLINE_xXFasting serum glucose =< 130 mg/dLXx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXFasting cholesterol =< 300 mg/dL and triglycerides =< 2.5 x IULN obtained within 28 days prior to registration; patients may be on lipid lowering agents to reach these valuesXx_NEWLINE_xXWithin less than or equal to 14 days prior to registration: Fasting serum glucose =< 130 mg/dLXx_NEWLINE_xXWithin less than or equal to 14 days prior to registration: Fasting triglycerides =< 300 mg/dLXx_NEWLINE_xXDiabetics are allowed if:\r\n* Fasting blood glucose (FBG) =< 130 mg/dL (mmol/L),\r\nOR\r\n* HbA1c =< 7%Xx_NEWLINE_xXPatients must have a normal blood sugar level for age to participate; if an initial random draw (ie. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting drawXx_NEWLINE_xXPatients must have a normal blood sugar level for age; if an initial random draw (i.e. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting drawXx_NEWLINE_xXPatients must have a serum triglyceride level =< 300 mg/dL and serum cholesterol level =< 300 mg/dL; if an initial random draw (i.e. non-fasting) is out of range, it is acceptable to repeat this test as a fasting drawXx_NEWLINE_xXFasting glucose =< 120 mg/dL and hemoglobin A1c (HbA1c) < 7%Xx_NEWLINE_xXFasting glucose =< 126 mg/dL (7.0 mmol/L)Xx_NEWLINE_xXFasting plasma glucose < 140 mg/dL/7.8 mmol/LXx_NEWLINE_xXFasting serum glucose (=< 130 mg/dL)Xx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXSerum triglyceride level =< 300 mg/dL and serum cholesterol =< 300 mg/dL; if these labs were drawn non-fasting and do not meet the eligibility criteria then it is suggested that they are repeated fasting, i.e. no food or drink other than water for 8 hours; the use of medication to achieve these parameters is not allowedXx_NEWLINE_xXRandom or fasting blood glucose within the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then a follow-up fasting (no food or drink other than water for 8 hours) blood glucose can be obtained and must be within the upper limits for ageXx_NEWLINE_xXUncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)Xx_NEWLINE_xXFasting glucose under control (< 150 mg/dL [8.3 mmol/L])Xx_NEWLINE_xXTotal cholesterol < 300 mg/dLXx_NEWLINE_xXTriglycerides < 250 mg/dLXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXUncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL); if a patient is excluded solely based upon a non-fasting triglyceride level, a fasting test should be performed to determine eligibilityXx_NEWLINE_xXPoorly-controlled diabetes mellitus, as defined as fasting serum glucose concentration over 200 mg/dl or glycated hemoglobin (A1C) over 7.5%.Xx_NEWLINE_xXPatients must have a fasting LDL cholesterol within the normal range per institutional guidelinesXx_NEWLINE_xX=< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXUncontrolled diabetes as defined by fasting serum glucose > 1.5x ULNXx_NEWLINE_xXFasting total cholesterol ?300 mg/dL (or ?7.75 millimoles [mmol]/L) and/or fasting triglycerides level ?2.5 × the ULN. Note: these participants can be included after initiation or adjustment of lipid-lowering medication.Xx_NEWLINE_xXUncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medication.Xx_NEWLINE_xXFasting plasma glucose < 140 mg/dL / 7.7 mmol/L and glycosylated hemoglobin (HbA1c) =< 8% (both criteria have to be met)Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dl or 7.75 mmol/L and fasting triglycerides =< 2.5 × ULN; in case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achievedXx_NEWLINE_xXNormal blood glucose for ageXx_NEWLINE_xXGlycated hemoglobin (Hb A1c) =< 5.7%, or 5.8-6.5% with a normal fasting glucoseXx_NEWLINE_xXPatients must have cholesterol level < 350 mg/dL and triglycerides < 400 mg/dL before starting therapy; in case one or both of these are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication and documentation of cholesterol < 350 mg/dL and triglycerides < 400 mg/dl before start of therapyXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dLXx_NEWLINE_xXFasting triglyceride =< 2.5 x ULNXx_NEWLINE_xXMetabolic status: HbA1c < 7.0%, fasting serum glucose ? 130 mg/dL, and fasting triglycerides ? 300 mg/dL.Xx_NEWLINE_xXGlucose, serum < 200 mg/dLXx_NEWLINE_xXFasting cholesterol =< 1.5 x ULNXx_NEWLINE_xXHyperglycemia (fasting) ? Grade 2Xx_NEWLINE_xXFasting plasma glucose (FPG) =< 160 mg/dL or 7.8 mmol/LXx_NEWLINE_xXDiagnosis of diabetes mellitus defined as\r\n* Fasting blood glucose > 126 mg/dl or\r\n* Random blood glucose > 200 mg/dl\r\n* Hemoglobin A1C > 6.5%Xx_NEWLINE_xXPatients with uncontrolled diabetes or fasting blood glucose > 200 mg/dL may enroll but will not be evaluable for PET imagingXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXFasting serum glucose (=< 130 mg/dL)Xx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXPoorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications; patients with diabetes will preferably be scheduled for PET/CT imaging in the morning, and instructions for fasting and use of medications will be provided in consultation with the patients’ primary physiciansXx_NEWLINE_xXDiabetes must be controlled prior to PET-CT scanning (blood glucose < 200 mg/dL)Xx_NEWLINE_xXFasting serum triglyceride level =< 500 mg/dLXx_NEWLINE_xXSerum cholesterol levels must be less than grade 2 (< 300 mg/dL), and serum triglyceride levels must be less than grade 2 (< 2.5 x ULN)Xx_NEWLINE_xXFasting glucose within normal limitsXx_NEWLINE_xXFasting plasma glucose =< 200 mg/dLXx_NEWLINE_xXObtained =< 14 days prior to registration: Fasting serum glucose =< 1.5 x ULNXx_NEWLINE_xXFasting serum glucose =< 130 mg/dL.Xx_NEWLINE_xXFasting triglycerides =< 300 mg/dL.Xx_NEWLINE_xXFasting blood glucose (FBG) < 130 mg/dLXx_NEWLINE_xXSevere and uncontrolled Cushing syndrome despite medical management (e.g., systolic blood pressure > 160 mmHg or hyperglycemia with fasting glucose above 300 mg/dL).Xx_NEWLINE_xXFasting or random blood glucose within the upper limits of normal for ageXx_NEWLINE_xXIf random blood glucose is above upper limits for age, a fasting blood glucose can be obtained and must be within normal limits for ageXx_NEWLINE_xXFasting or non-fasting serum triglyceride level =< 300 mg/dL and serum cholesterol level =< 300 mg/dLXx_NEWLINE_xXUncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL).Xx_NEWLINE_xXFasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)Xx_NEWLINE_xXOnly for subjects enrolled in Arm 1 - Neratinib and everolimus: fasting lipid profile: cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL.Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXCholesterol =< 300 mg/dLXx_NEWLINE_xXFasting serum glucose < 130 milligram per deciliter (mg/dL) and fasting triglycerides <= 300 mg/dL.Xx_NEWLINE_xXFasting serum glucose (=< 130 mg/dL)Xx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXFasting serum glucose =< 130 mg/dLXx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXFasting glucose =< 160 mg/dL (CTCAE grade 1 baseline)Xx_NEWLINE_xXHistory of Type 1 or 2 diabetes mellitus requiring regular medication (other than oral hypoglycemic agents) or fasting glucose ? 160 mg/dL at the Pre-Study visitXx_NEWLINE_xXFasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)Xx_NEWLINE_xXFasting serum glucose (=<130 mg/dL)Xx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXMetabolic: fasting serum glucose (=< 130 mg/dL)Xx_NEWLINE_xXMetabolic: fasting triglycerides =< 300 mg/dLXx_NEWLINE_xXGlycosylated hemoglobin (HbA1c) > 8.5% or fasting plasma glucose > 160 mg/dL at screeningXx_NEWLINE_xXFasting serum glucose (=< 130 mg/dL)Xx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXCERITINIB INCLUSION CRITERIA: Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXFasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)Xx_NEWLINE_xXSerum triglyceride level =< 300 mg/dL within 7 days prior to enrollmentXx_NEWLINE_xXSerum total cholesterol level =< 300 mg/dL within 7 days prior to enrollmentXx_NEWLINE_xXFasting serum glucose =< 130 mg/dLXx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXHistory of Type 1 or 2 diabetes mellitus requiring regular medication (other than oral hypoglycemic agents including metformin) or fasting glucose ? 160 mg/dLXx_NEWLINE_xXGlucose >= 80 mg/dLXx_NEWLINE_xXFor patients without known type II diabetes, the following is required at screening:\r\n* Fasting plasma glucose =< 160 mg/dL (7.49 mmol/L) and glycosylated hemoglobin (HbA1c) < 7.5 % or International Federation of Clinical Chemistry (IFCC) < 53 mmol/molXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L, AND fasting triglycerides =< 2.5 x\r\nULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXSerum cholesterol and serum triglyceride levels must be less than 300 mg/dlXx_NEWLINE_xXMagnesium < 1.4 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levelsXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR >= 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXFasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)Xx_NEWLINE_xXHave uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)Xx_NEWLINE_xXSerum triglycerides < 300mg/dL fasting or on a random plasma testXx_NEWLINE_xXFasting serum glucose =< 130 mg/dLXx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXFasting plasma glucose =< 120 mg/dL (6.7 mmol/L)Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; note: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication with confirmed reduction of lab values to within eligibility parametersXx_NEWLINE_xXSubjects unable to maintain blood glucose less than 200 mg/dl may not be suitable for the PET/MRI substudyXx_NEWLINE_xXGlucose < 200 mg/dLXx_NEWLINE_xXKnown diabetes (type 1 or 2), fasting glucose > or equal to 7.0 mmol/L (126 mg/dL), or HgbA1C > 6.5Xx_NEWLINE_xXFasting level of total cholesterol of no more than 350 mg/dLXx_NEWLINE_xXUncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)Xx_NEWLINE_xXPoorly controlled diabetes, fasting blood sugar (FBS) >= 200 mg/dLXx_NEWLINE_xXUncontrolled diabetes mellitus, or subjects with either of the following:\r\n* Fasting blood glucose (FBG defined as fasting for at least 8 hours) >= 200 mg/dL (7.0 mmol/L), or\r\n* Glycosylated hemoglobin measurement (HbA1c) >= 8%Xx_NEWLINE_xXWithin 4 weeks of preregistration: Blood glucose =< 126 mg/dL fasting or =< 140 mg/dL nonfastingXx_NEWLINE_xXELIGIBILITY CRITERIA FOR REGISTRATION: blood glucose =< 126 mg/dL fasting or =< 140 mg/dL nonfasting (within one week of registration if patient postop, otherwise within two weeks of registration)Xx_NEWLINE_xXEXCLUSION CRITERIA FOR REGISTRATION: subjects with known diabetes, fasting glucose over 126 mg/dL or random glucose over 140 mg/dL and those taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason; either fasting OR random glucose may be used to determine eligibilityXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND\r\n* NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXFasting triglycerides =< 2.5 x ULN\r\n* NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXFasting serum cholesterol < 300 mg/dL and triglycerides < 2.5 x ULN; Note: in case one or both of these thresholds are exceeded, the patient can be included after initiation of appropriate lipid lowering medication if on repeat analysis, both levels fall within parametersXx_NEWLINE_xXFasting blood sugar =< 160 mg/dL; patient may be on diabetic medication to achieve glucose control\r\n* Documented fasting blood sugars =< 160 mg/dL\r\n* Diabetic subjects who have recently had their glycemic control regimens adjusted and have documented fasting blood glucose concentrations =< 160 mg/dL may be considered regardless of hemoglobin A1C (HgbA1c) value, if per investigator discretion the subject is considered to have adequate glycemic functionXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical, psychiatric or social conditions that could compromise the safety or compliance of treatment as so judged by treating physician\r\n* Examples include but are not limited to:\r\n** History of severely impaired lung function defined as spirometry and diffusion capacity of carbon monoxide (DLCO) that is =< 50% of the normal predicted value and/or 02 saturation that is =< 88% at rest on room air\r\n** Uncontrolled diabetes mellitus consistent fasting blood glucose readings > 160 mg/dL or < 50 mg/dL); use of diabetic medications is permitted\r\n** Hyperlipidemia (total cholesterol > 300-400; triglycerides > 300); use of lipid lower lowering agents is permitted\r\n** Other: e.g. severe infection, severe malnutrition, ventricular arrhythmias, known active vasculitis of any cause, tumor invasion of any major blood vessel, severe chronic liver or renal disease, active upper GI tract ulcerationXx_NEWLINE_xXFasting plasma glucose =< 120 mg/dL (6.7 mmol/L) (Gedatolisib can cause hyperglycemia)Xx_NEWLINE_xXFasting plasma glucose =< 120 mg/dLXx_NEWLINE_xXFasting plasma glucose (FPG) =< 140 mg/dL or =< 7.8 mmol/LXx_NEWLINE_xXFasting plasma glucose (FPG) =< 140mg/dL or =< 7.8 mmol/LXx_NEWLINE_xXPatient has fasting plasma glucose (FPG) ?140 mg/dL (7.7 mmol/L) and glycosylated hemoglobin (HbA1c) ? 6.4% (both criteria have to be met)Xx_NEWLINE_xXFasting triglyceride =< 200 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)Xx_NEWLINE_xXFasting cholesterol =< 240 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)Xx_NEWLINE_xXWithin 14 days of step 1 registration, unless corrected prior to step 1 registration: Fasting glucose < 40 mg/dl or > 400 mg/dlXx_NEWLINE_xXGlucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14mmol/L)Xx_NEWLINE_xXMagnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levelsXx_NEWLINE_xXTREATMENT: For patients on everolimus, fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x upper limit of normal (ULN); NOTE: in case one or both of these thresholds are exceeded, the patient can receive everolimus on study only after initiation of appropriate lipid lowering medication with follow up documentation of values below the above cut-offXx_NEWLINE_xXTREATMENT: Patients who have poorly controlled diabetes (defined as fasting blood glucose of > 160 mg/dL (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) and glycated hemoglobin (HgA1c) > 8% are ineligible to receive treatment with everolimus on study; patients with fasting blood glucose > 160 mg/dL may be eligible if the HgA1c < 8%, per PI discretionXx_NEWLINE_xXGlucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L)Xx_NEWLINE_xXMagnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levelsXx_NEWLINE_xXFasting cholesterol less than or equal to 300 mg/dl; fasting triglycerides less than or equal to 300 mg/dlXx_NEWLINE_xXPatients with uncontrolled diabetes mellitus (fasting blood glucose controlled by medication, =< 200 mg/dL allowed)Xx_NEWLINE_xXUncontrolled diabetes (if random blood sugar > 200 mg/dL, perform fasting blood sugar to ensure < 200 mg/dL)Xx_NEWLINE_xXSerum triglyceride =< 300 mg/dL (applicable only for dose levels that include isotretinoin) (note that a non-fasting triglyceride value could be obtained, if this is > 300 mg/dL then a fasting triglyceride should be obtained and patient will be eligible if the fasting level is =< 300 mg/dL)Xx_NEWLINE_xXSubjects with fasting plasma glucose ? 125 mg/dL and HbA1c < 6.5 % at screening\n             Subjects with fasting plasma glucose ?150 mg/dL and HbA1c ? 7.0 % at screening for\n             the Diabetes Expansion Cohort.Xx_NEWLINE_xXFasting plasma glucose (FPG) =< 140 mg/dL (7.7 mmol/L) and glycosylated hemoglobin (HbA1c) =< 6.4% (both criteria have to be met)\r\n* For patients with FPG >= 100 mg/dL and/or HbA1c >= 5.7% (i.e. threshold for pre-diabetes) at screening, recommend lifestyle changes according to American Diabetes Association (ADA) guidelines, i.e. dietary advice (e.g. small frequent meals, low carbohydrate content, high fiber, balancing carbohydrate intake over the course of the day, three small meals and 2 small snacks rather than one large meal) and exercise; a consultation with a diabetologist is highly recommendedXx_NEWLINE_xXFasting glucose < 125 mg/dL obtained within 28 days prior to sub-study registrationXx_NEWLINE_xXFasting glucose < 125 mg/dL obtained within 28 days prior to Step 2 re-registrationXx_NEWLINE_xXFasting glucose =< 120 mg/dLXx_NEWLINE_xXWithin 14 days of subject registration: Fasting plasma glucose =< 140 mg/dL or 7.8 mmol/L\r\n* (NOTE: Fasting whole blood glucose testing is acceptable if fasting plasma glucose is not feasible)Xx_NEWLINE_xXSignificant electrolyte imbalance prior to enrollment:\r\n* Hypomagnesemia < 1.2 mg/dL or 0.5 mmol/L\r\n* Hypocalcemia < 8.0 mg/dL or 2.0 mmol/L\r\n* Hypokalemia < 3.0 mmol/LXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXUncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULNXx_NEWLINE_xXFasting blood glucose =< 125 mg/dL within 14 days prior to registrationXx_NEWLINE_xXFasting plasma glucose (FPG) =< 140 mg/dLXx_NEWLINE_xXMetabolic: fasting serum glucose (=< 130 mg/dL) and fasting triglycerides =< 300 mg/dLXx_NEWLINE_xXFasting serum glucose < 126 mg/dl (7 mmol/l)Xx_NEWLINE_xXFasting glucose < 160 mg/dLXx_NEWLINE_xXPatients with abnormal fasting glucose values at screening will be excluded (fasting glucose >= 160); in addition, patients with type 1 diabetes will also be excluded; however, patients with type 2 diabetes will be allowed if diagnosed >= 6 months prior to enrollment, and if presenting with hemoglobin A1C (HbA1C) =< 8% at screeningXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXBaseline cholesterol must be < 350 mg/dL and triglycerides < 300 mg/dL (with or without the use of antihyperlipidemic medications)Xx_NEWLINE_xXBaseline fasting blood glucose must be =< 140 mg/dL and hemoglobin A1c less than 7.5% (with or without the use of anti-diabetic medications)Xx_NEWLINE_xXPoorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medicationsXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXPatient has uncontrolled diabetes, defined as a fasting serum glucose > 150 mg/dl or glycosylated hemoglobin (hemoglobin A1c [HbA1c]) > 7% at screeningXx_NEWLINE_xXFasting plasma glucose =< 120 mg/dL (6.7 mmol/L)Xx_NEWLINE_xXNormal fasting glucoseXx_NEWLINE_xXDiabetes or elevated fasting blood sugar either by history or by hemoglobin A1c (HgbA1c) greater than 6.5% or fasting serum glucose greater than 100 mg/dL on screening labs; if fasting serum glucose is greater than 100mg/dL on screening labs, this test will be repeated to confirm the resultsXx_NEWLINE_xXAdequate cardiac function (left ventricular ejection fraction >= 50% as measured by echocardiogram or multigated acquisition [MUGA] scan)\r\n* Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient may be included after initiation of appropriate lipid lowering medication with approval from the principal investigatorXx_NEWLINE_xXUncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULNXx_NEWLINE_xXFasting plasma glucose < 140 mg/dl (may be on antiglycemic agents other than insulin); fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intakeXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/LXx_NEWLINE_xXFasting triglycerides =< 300 mg/dL or =< 1.71 mmol/LXx_NEWLINE_xXFasting glucose value ? 160 mg/dL (CTCAE Grade 1 baseline)Xx_NEWLINE_xXPatients must not have uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 x ULN) obtained within 28 days prior to registration; optimal lipid control must be achieved before registration and monitored during protocol treatmentXx_NEWLINE_xXPatients must not have uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 x ULN) obtained within 28 days prior to registration; optimal glucose control must be achieved before registration and monitored during protocol treatmentXx_NEWLINE_xXUncontrolled diabetes, as evidenced by fasting serum glucose level >200 mg/dLXx_NEWLINE_xXFasting serum triglyceride level =< 500 mg/dLXx_NEWLINE_xXFasting serum cholesterol ? 300 mg/dl or 7.75 mmol/L and fasting triglycerides ? 2.5 × ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achievedXx_NEWLINE_xXGlucose =< 2 x ULNXx_NEWLINE_xXScreening fasting lipid panel: LDL cholesterol < 190 mg/dL, triglycerides < 300 mg/dLXx_NEWLINE_xXGlycosylated hemoglobin (HbA1c) less than (<) 7.0%, fasting serum glucose <=130 milligram per deciliter (mg/dL), and fasting triglycerides <=300 mg/dL.Xx_NEWLINE_xXFasting serum cholesterol less than or equal to 300 mg/dLXx_NEWLINE_xXFasting triglycerides less than or equal to 300 mg/Xx_NEWLINE_xXFasting plasma glucose < 8.9 mmol/L (< 160 mg/dL) and HbA1c < 8.0%. Inclusion criteria only for patients entering phase Ib escalation and phase II:Xx_NEWLINE_xXHave plasma total cholesterol < 300 mg/dLXx_NEWLINE_xXHave plasma total cholesterol > 300 mg/dLXx_NEWLINE_xXSerum triglyceride level =< 300 mg/dL (=< 3.42 mmol/L)Xx_NEWLINE_xXSerum cholesterol level =< 300 mg/dL (7.75 mmol/L)Xx_NEWLINE_xXRandom or fasting blood glucose within the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then a follow-up fasting blood glucose can be obtained and must be within the upper normal limits for ageXx_NEWLINE_xXGrade ?2 hypercholesterolemia (TC >300 mg/dL or >7.75 mmol/L) and/or hypertriglyceridemia (TG >300 mg/dL or >3.42 mmol/L) in the fasting state.Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXFasting serum cholesterol =< 240 mg/dL or =< 7.75 mmol/L and fasting triglycerides =< 2.5 x ULN. \r\n* NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.Xx_NEWLINE_xXPatients with uncontrolled type II (hemoglobin A1C [HbA1c] > 8% assessed locally) as judged by the investigator or abnormal fasting glucose value defined as > 126 mg/dL (> 7 mmol/L)Xx_NEWLINE_xXFasting plasma glucose (FPG) =< 120 mg/dL or =< 6.7 mmol/LXx_NEWLINE_xXFasting serum glucose =< 130 mg/dLXx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXFasting cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x IULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXPatient has: random glucose > 200 mg/dl or is taking an oral hypoglycemic agent or insulin at the time of study entryXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL or =< 7.75 mmol/L and fasting triglycerides =< 2.5 x ULN; in case of any of these thresholds be exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationsXx_NEWLINE_xXFasting glucose < 140 mg/dLXx_NEWLINE_xXBaseline fasting glucose of < 126 mg/dl (7 mmol/L)Xx_NEWLINE_xXKnown diabetes (type 1 or 2) or baseline fasting glucose >= 126 mg/dl (7 mmol/L)Xx_NEWLINE_xXFasting plasma glucose (FPG) < 140 mg/dL/7.8 mmol/L, where fasting is defined as no food intake for 8 hours prior to measurementXx_NEWLINE_xXType I diabetes mellitus (DM), type II DM patients requiring insulin for chronic blood glucose control, and any patients with a fasting blood glucose > 140 mg/dL (7.8 mmol/L) at screening will be excludedXx_NEWLINE_xXCholesterol level =< 350 mg/dl; fasting is not required before testing, but if elevated without fasting, repetition with fasting can be performed to determine eligibilityXx_NEWLINE_xXTriglycerides level =< 400 mg/dl; fasting is not required before testing, but if elevated without fasting, repetition with fasting can be performed to determine eligibilityXx_NEWLINE_xXPatients must have a fasting cholesterol =< 300 mg/dl OR =< 7.75 mmol/L and triglycerides =< 2.5 x IULN obtained within 28 days prior to registration; patients may be on lipid lowering agents to reach these valuesXx_NEWLINE_xXFasting plasma glucose =< 120 mg/dL (6.7 mmol/L)Xx_NEWLINE_xXFasting serum cholesterol less than or equal to 300 mg/dL OR less than or equal to 7.75 mmol/L AND fasting triglycerides less than or equal to 2.5 x ULNXx_NEWLINE_xXDiabetes mellitus on active treatment, or subjects with either of the following:\r\n* Fasting blood glucose (FBG) >= 126 mg/dL (7.0 mmol/L), or \r\n* Hemoglobin A1C (HbA1c) >= 6.5%Xx_NEWLINE_xXFasting glucose < 120 mg/dLXx_NEWLINE_xXPatients with a fasting blood glucose >= 120 mg/dL (6.7 mmol/L); patients with diabetes mellitus are eligible if they require oral agents only and have a fasting blood glucose =< 120 mg/dL; patients with a history of diabetes mellitus who require daily long-acting or mealtime insulin are not eligible; patients who have previously required treatment for hyperglycemia due to steroids or other medications are eligible as long as they have not required insulin or any other oral agent within 2 months prior to study enrollmentXx_NEWLINE_xXAt least 4 weeks (28 days) prior to registration: Fasting plasma glucose (FPG) < 140 mg/dL/7.8 mmol/LXx_NEWLINE_xXNormal fasting cholesterol and triglyceridesXx_NEWLINE_xXFasting glucose < 250 mg/dL; patients with diabetes are allowed to participate, provided that their blood glucose is < 250 mg/dL upon enrollmentXx_NEWLINE_xXFasting blood glucose within institutional normal limitsXx_NEWLINE_xXAdditional criteria for Group B participants who will receive upfront window therapy (does not apply to participants who opt out of window therapy):\r\n* Cytochrome P450 3A4 (CYP3A4) active agents: must not be taking any of the following potent CYP3A4 inducers or inhibitors within 1 week prior to study entry: azole antifungals (such as fluconazole, voriconazole, itraconazole, ketoconazole), rifampin, phenytoin, phenobarbital, carbamazepine, grapefruit juice and St. John’s wort\r\n* Must have measurable disease\r\n* Must not have received emergent radiation therapy\r\n* Serum triglyceride level =< 300 mg/dL and serum cholesterol =< 300 mg/dL\r\n* Random or fasting glucose within the upper limits of normal for age; if random glucose is elevated, fasting glucose must be within normal rangeXx_NEWLINE_xXPART B: Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dl OR =< 7.75 mmol/l AND fasting triglycerides =< 2.5 times ULN*Xx_NEWLINE_xXUncontrolled diabetes, as defined by fasting serum glucose > 1.5 times ULN*Xx_NEWLINE_xXFasting plasma glucose < 140 mg/dl (may be on antiglycemic agents other than insulin); fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intakeXx_NEWLINE_xXUncontrolled diabetes (as defined by fasting glucose >= 140 mg/dL) and/or insulin-dependent diabetes; fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intake; patients currently requiring the use of antiglycemic agents (other than insulin) may be enrolled if fasting glucose < 140 mg/dLXx_NEWLINE_xXFasting plasma glucose =< 120 mg/dL (6.7 mmol/L), if not consider initiation of metformin treatment prior to study treatmentXx_NEWLINE_xXFasting serum cholesterol =< 240 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXObtained within 2 weeks from study entry: Fasting plasma glucose =< 140 mg/dLXx_NEWLINE_xXPatients with fasting serum cholesterol > 300 mg/dL OR > 7.75 mmol/L AND fasting triglycerides > 2.5 x upper limit of normal (ULN) should initiate lipid lowering medicationsXx_NEWLINE_xXPatients with fasting serum cholesterol > 300 mg/dL OR > 7.75 mmol/L AND fasting triglycerides > 2.5 x ULN who would need to initiate lipid lowering medicationsXx_NEWLINE_xXCholesterol > 300 mg/dl or triglycerides > 400 mg/dl despite treatmentXx_NEWLINE_xXType I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at screening.Xx_NEWLINE_xXPatients with diabetes, OR fasting blood glucose level >= 126 mg/dl\r\n* NOTE: patients with drug induced diabetes are eligible if the offending drug has been stopped and the patient’s fasting blood glucose level has recovered to < 126 mg/dlXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR ? 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL or =< 7.75 mmol/L AND fasting triglycerides =< 300 mg/dL or 3.42 mmol/L\r\n* NOTE: non-fasting cholesterol/triglyceride levels that meet these criteria are acceptable; if these thresholds are exceeded in non-fasting samples, then fasting samples should be obtained\r\n* NOTE: if one or both of these thresholds are exceeded in fasting samples, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXIndividuals with severe and/or uncontrolled intercurrent illness including, but not limited to:\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n* Unstable angina pectoris, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia or other clinically significant cardiac disease\r\n* Uncontrolled diabetes as defined by fasting serum glucose >= 200 mg/dL (note: participants with history of hyperglycemia receiving medical management whose fasting serum glucose is < 200 mg/dL with that management are eligible for enrollment)\r\n* Psychiatric illness/social situations that would limit compliance with study requirementsXx_NEWLINE_xXKnown uncontrolled hyperlipidemia defined as LDL-C >= 190 mg/dL or triglycerides >= 500 mg/dLXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN\r\n* NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXHistory of diabetes requiring treatment, glucose >126 mg/dL, Glycated hemoglobin (HbA1c) ?6.5%Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x upper limit of normal (ULN); NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXARM A: Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L); ARM B: Fasting plasma glucose =< 140 mg/dL (7.8 mmol/L); hemoglobin A1c (HbA1c) =< 8%; ARMS C and D: Fasting plasma glucose =< 150 mg/dLXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXCholesterol =< 350 mg/dLXx_NEWLINE_xXHave uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)Xx_NEWLINE_xXTotal cholesterol =< 300 mg/dL AND fasting triglycerides =< 2.5 x institutional ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXEXPANSION COHORT ONLY: Total cholesterol =< 300 mg/dL AND fasting triglycerides =< 2.5 x institutional ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXf. Poorly controlled diabetes (fasting blood glucose > 180 mg/dL)Xx_NEWLINE_xXFasting total cholesterol >300 milligram per deciliter (mg/dL) (or ?7.75 millimole per liter (mmol/L)) and/or fasting triglycerides level ?2.5 x upper limit of normal (ULN). Note: these subjects can be included after initiation or adjustment of lipid-lowering medicationXx_NEWLINE_xXUncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medicationXx_NEWLINE_xXFasting level of total cholesterol of no more than 350 mg/dLXx_NEWLINE_xXFasting serum glucose =< 150 mg/dl (fasting is defined as at least 8 hours without oral intake)Xx_NEWLINE_xXFasting blood glucose of ? 140 mg/dL (7.8 mmol/L).Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L ANDXx_NEWLINE_xXFasting triglycerides =< 2.5 x ULNXx_NEWLINE_xXNOTE: In case one or both of these thresholds (for fasting serum cholesterol or triglyceride) are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXFasting blood glucose of ? 140 mg/dL (7.8 mmol/L).Xx_NEWLINE_xXFasting plasma glucose =< 120 mg/dL (6.7 mmol/L)Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXPatients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with Fasting Plasma Glucose (FPG) ? 140 mg/dL / 7.8 mmol/LXx_NEWLINE_xXUncontrolled (? Grade 2) hypertriglyceridemia (fasting triglycerides > 300 mg/dL (3.42 mmol/L))Xx_NEWLINE_xXFasting plasma glucose > 120mg/dL or > 6.7 mmol/LXx_NEWLINE_xXPatient does not have uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL)Xx_NEWLINE_xXPatient with diabetes mellitus: fasting glucose =< 120 mg/dL and hemoglobin A1c (HbA1c) =< 8%Xx_NEWLINE_xXFasting glucose of ?126 mg/dL (7.0 mmol/L).Xx_NEWLINE_xXHyperglycemia (fasting) >= Grade 2Xx_NEWLINE_xXFasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)Xx_NEWLINE_xXFor all patients (regardless of known diabetes) the following is required at screening: fasting blood glucose =< 135 mg/dL (7.49 mmol/L) and glycosylated hemoglobin (HbA1c) =< 7.0%Xx_NEWLINE_xXFasting serum glucose =< 130 mg/dLXx_NEWLINE_xXUncontrolled diabetes mellitus (fasting plasma glucose > 130 mg/dL)Xx_NEWLINE_xXFasting serum cholesterol > 300 mg/dL OR > 7.75 mmol/L or fasting triglycerides > 2.5 x ULN; NOTE: in case of one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXGlycated hemoglobin (HgbA1c) ? 7 %; Fasting Plasma Glucose (FPG) ? 7.0 mmol/L (125 mg/dL).Xx_NEWLINE_xXFasting glucose > 7.0 mmol/L (126 mg/dL). or HbA1c > 6.4%.Xx_NEWLINE_xXActive brain metastasis or treatment for brain metastasis within 1 month of scheduled dosing day 1. a. Dose of corticosteroid, if any, for brain metastasis must be tolerated in terms of glucose tolerance ? Grade 2 (symptomatic; dietary modification or oral agent indicated) and hyperglycemia ? Grade 2 (fasting glucose value >160 - 250 mg/dL [> 8.9Xx_NEWLINE_xXFasting glucose less than or equal to (</=) 125 milligrams per deciliter (mg/dL)Xx_NEWLINE_xXSerum fasting triglyceride level =< 300 mg/dL (=< 3.42 mmol/L) and serum cholesterol level =< 300 mg/dL (=< 7.75 mmol/L)Xx_NEWLINE_xXFasting glucose < 140 mg/dL (7.8 mmol/L).Xx_NEWLINE_xXFasting plasma glucose < 8.9 mmol/L (< 160mg/dL) and HbA1C < 8%Xx_NEWLINE_xXPatients with abnormal fasting glucose values (values > upper limit of normal [ULN] or < LLN) at screening will be excluded; in addition, patients with type 1 diabetes will also be excluded; however, patients with type 2 diabetes will be allowed if diagnosed >= 6 months prior to enrollment, and if presenting with a normal fasting glucose value and a regular hemoglobin A1C (HbA1C) =< 8% at screeningXx_NEWLINE_xXFasting plasma glucose (FPG) ? 120 mg/dL or ? 6.7 mmol/LXx_NEWLINE_xXSubjects with fasting glucose >125 mg/dL in 2 independent measurements or glycated hemoglobin (HbA1c) ? 7%Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXFasting serum glucose < 1.5 x ULN obtained =< 7 days prior to registrationXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN obtained =< 90 days prior to registration; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXPoorly controlled diabetes as defined by a fasting serum glucose > 2.0 x ULN.Xx_NEWLINE_xXfasting serum cholesterol ?300 mg/dL OR ?7.75 mmol/L AND fasting triglycerides ?2.5 x ULN.Xx_NEWLINE_xXUncontrolled diabetes as defined by fasting serum glucose >1.5 x ULNXx_NEWLINE_xXFasting plasma glucose =< 120 mg/dL (6.7 mmol/L)Xx_NEWLINE_xXFasting glucose =< 150 mg/dLXx_NEWLINE_xXFasting cholesterol level < 350 mg/dlXx_NEWLINE_xXFasting triglycerides =< 300 mg/dlXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXIf diabetic and taking insulin or oral anti-diabetic therapy, must have hemoglobin A1c (HbA1c) =< 8%, or a fasting serum glucose =< 110% ULNXx_NEWLINE_xXFasting plasma glucose (FPG) =< 120 mg/dL or 6.7 mmol/LXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x upper limit of normal (ULN); NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXPatients with a fasting plasma glucose > 1.5 ULN; Note: at the principle investigator’s discretion, non-eligible patients can be re-screened after adequate medical therapy has been institutedXx_NEWLINE_xXThe participant has fasting serum glucose less than or equal to 125 mg/dL, and hemoglobin A1C less than or equal to 6%.Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x upper limit of normal (ULN); NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXCurrent diagnosis of type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, or HbA1c 7%Xx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXUncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULNXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXThe participant has fasting serum glucose < 160 milligram/deciliter (mg/dL) and hemoglobin A1c (HgbA1c)? 7. If baseline nonfasting glucose is < 160 mg/dL, fasting glucose measurement is not requiredXx_NEWLINE_xXFasting serum glucose (=< 130 mg/dL)Xx_NEWLINE_xXFasting triglycerides =< 300 mg/dLXx_NEWLINE_xXFasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L) - if glucose is checked in the non fasting state and it is =< 175 mg/dL then this will be acceptableXx_NEWLINE_xXFasting plasma glucose < 120 mg/dLXx_NEWLINE_xXFasting total cholesterol ?300 milligrams (mg)/dL (or ?7.75 millimoles [mmol]/L) or fasting triglycerides level ?2.5 × ULN. Note: these participants can be included after initiation or adjustment of lipid-lowering medication.Xx_NEWLINE_xXUncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: In case this threshold is exceeded, these participants can only be included after initiation or adjustment of glucose-lowering medication.Xx_NEWLINE_xXFasting glucose < grade 2 (=< 160 mg/dL or =< 8.9 mmol/L) without the use of antihyperglycemic agentsXx_NEWLINE_xXFree from history of chronic disease including uncontrolled diabetes (fasting blood glucose > 125 mg/dL), hypertension (blood pressure > 130/90 mmHg) or thyroid disease (< 0.4 or > 4.0 mIU/L); this will be determined by review of medical records and/or physician clearanceXx_NEWLINE_xXUncontrolled diabetes mellitus (fasting blood sugar > 200 mg/dl) at screeningXx_NEWLINE_xXDiabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dLXx_NEWLINE_xXNON-CANCER PATIENT GROUP: Metabolically unhealthy: abdominal obesity + (at least one of the following: resting blood pressure above 140 systolic or 90 diastolic or anti-hypertensive medication use or fasting glucose above 100 mg/dL or type II diabetes mellitus)Xx_NEWLINE_xXFasting plasma glucose =< 130 mg/dL (or 7.2 mmol/L)Xx_NEWLINE_xXFasting triglycerides =< 300 mg/dL (3.42 mmol/L)Xx_NEWLINE_xXCholesterol =< 300 mg/dL (7.75 mmol/L)Xx_NEWLINE_xXPatients with poorly controlled diabetes mellitus with fasting serum glucose concentration over 200 mg/dl or a hemoglobin A1C over 7.5%.Xx_NEWLINE_xXUncontrolled hyperglycemia as defined by any blood glucose of > 300 mg/dl in the past two weeksXx_NEWLINE_xXRandom glucose < 160 mg/dL or fasting glucose < 126 mg/dL (other values require workup to rule out undiagnosed diabetes that may require treatment)Xx_NEWLINE_xXCurrently on medications for diabetes treatment (patients with hyperglycemia [random glucose < 160 mg/dL or fasting glucose < 126 mg/dl] but who are not on any drug treatment are eligible)Xx_NEWLINE_xXPatients with a history of or known diagnosis of diabetes according to national guidelines (fasting plasma glucose >= 126 mg/dL or random plasma glucose >= 200 mg/dL), as evidenced in laboratory values =< 3 months oldXx_NEWLINE_xXPatients with fasting capillary blood glucose of > 140 on the day of surgeryXx_NEWLINE_xXFasting blood glucose =< 120 mg/dLXx_NEWLINE_xXFasting blood glucose level > 126 and glycosylated hemoglobin (HbA1c) > 7%.Xx_NEWLINE_xXTriglycerides =< 150 mg/dlXx_NEWLINE_xXTotal cholesterol =< 200 mg/dlXx_NEWLINE_xXFasting cholesterol > 300 mg/dl or triglycerides > 300 while on lipid lowering agentsXx_NEWLINE_xXNon-fasting blood glucose >= 200 mg/dL, or hemoglobin A1C (HbA1C) >= 7%Xx_NEWLINE_xXFasting blood glucose =< 115 mg/dLXx_NEWLINE_xXIt is recommended the lipid profile be drawn fasting >= 8 hrs; serum lipid profile: total cholesterol/high-density lipoprotein (HDL)/low-density lipoprotein (LDL)/triglycerides (LDL levels prior to chemotherapy must be =< 190 mg/dl), within 30 days prior to enrollment\r\n* If labs are drawn non-fasting and LDL levels are >= 190 mg/dl the lipid profile should be repeated fasting to determine eligibilityXx_NEWLINE_xXIt is recommended glucose be drawn fasting >= 8 hrs; glucose < 126 (diabetics 40–75 years of age are not eligible), within 30 days prior to enrollment\r\n* If glucose is >= 126 the glucose should be repeated fasting to determine eligibilityXx_NEWLINE_xXFasting serum cholesterol =< 300 mg/dL or =< 7.75 mmol/L and fasting triglycerides =< 2.5 x ULN; Note: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medicationXx_NEWLINE_xXFasting serum glucose =< 130 MG/DLXx_NEWLINE_xXFasting plasma glucose < 140 mg/dL/7.7 mmol/LXx_NEWLINE_xX12 hour fasting glucose level < 7.0 mmol/LXx_NEWLINE_xXNo known diabetes (type 1 or 2) or baseline fasting glucose >= 7.0 mmol/LXx_NEWLINE_xXNot frankly diabetic, as measured by a fasting blood glucose =< 126 mg/dLXx_NEWLINE_xXTriglycerides (fasting) >= 400Xx_NEWLINE_xXType I or II diabetes; documented fasting plasma glucose > 125 mg/dL, current exposure to antidiabetic medications, including insulinXx_NEWLINE_xXFasting cholesterol =< 1.5 x ULNXx_NEWLINE_xXGlucose within 2 x ULNXx_NEWLINE_xXPlasma glucose =< 200 mg/dLXx_NEWLINE_xXPlasma glucose > 200 mg/dLXx_NEWLINE_xXBlood glucose > 200Xx_NEWLINE_xXHave plasma total cholesterol < 200 mg/dLXx_NEWLINE_xXHave plasma triglycerides < 200 mg/dLXx_NEWLINE_xXHave plasma total cholesterol > 200 mg/dL or plasma triglycerides > 200 mg/dLXx_NEWLINE_xXPatients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)Xx_NEWLINE_xXUncontrolled diabetes or blood glucose > 175 mg/dl on the day of the FDG-PET scanXx_NEWLINE_xXPatients with diabetes mellitus, with uncontrolled fasting blood glucose level (above 200 mg/dl)Xx_NEWLINE_xXSevere diabetes (fasting blood glucose > 200 mg/dl)Xx_NEWLINE_xXUncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)Xx_NEWLINE_xXUncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)Xx_NEWLINE_xXPatients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)Xx_NEWLINE_xXPatient with poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL; optimally participants will have glucose < 150 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medicationsXx_NEWLINE_xXBlood glucose >= 200 mg/dL at the time of PET-MRI (or if diabetic, uncontrolled blood glucose); at the discretion of the principal investigator (PI) and the authorized user and with their approval prior to FDG injection, patients with blood glucose >= 200 mg/dL may participate in the studyXx_NEWLINE_xXPatient must not be an uncontrolled diabetic with a glucose of >= 200 mg/dl at the time of PET imagingXx_NEWLINE_xXPatients with uncontrolled type II (glycosylated hemoglobin [HbA1c] > 8% assessed locally) as judged by the investigator or abnormal fasting glucose value defined as > 126 mg/dL (> 7 mmol/L)Xx_NEWLINE_xXUncontrolled diabetes or blood glucose > 180 mg/dl on the day of the fludeoxyglucose F 18 ([18F]FDG)-PET scanXx_NEWLINE_xXUncontrolled hyperglycemia (defined as inability to achieve a glucose of < 250 mg/dL at time of FDG injection)Xx_NEWLINE_xXBlood glucose of < 80 mg/dL or > 150 mg/dLXx_NEWLINE_xXUncontrolled diabetes with a fasting glucose >= 200 mg/dl at the time of PET/MRI imagingXx_NEWLINE_xXSerum glucose > 200 mg/dLXx_NEWLINE_xXFasting glucose > 200 mg/dL orXx_NEWLINE_xXFasting triglycerides > 300 mg/dLXx_NEWLINE_xXFasting serum glucose ?130 mg/dL and fasting triglycerides ?300 mg/dL.Xx_NEWLINE_xX