Random 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 age

Glucose < 200 mg/dl

Uncontrolled diabetes (if non-fasting blood sugar > 200 mg/dl, perform a fasting blood sugar which must be =< 200 mg/dl)

Fasting serum glucose =< 130 mg/dL

Fasting triglycerides =< 300 mg/dL

Fasting 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 values

Within less than or equal to 14 days prior to registration: Fasting serum glucose =< 130 mg/dL

Within less than or equal to 14 days prior to registration: Fasting triglycerides =< 300 mg/dL

Diabetics are allowed if:\r\n* Fasting blood glucose (FBG) =< 130 mg/dL (mmol/L),\r\nOR\r\n* HbA1c =< 7%

Patients 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 draw

Patients 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 draw

Patients 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 draw

Fasting glucose =< 120 mg/dL and hemoglobin A1c (HbA1c) < 7%

Fasting plasma glucose [fasting is defined as no calorific intake for at least 8 hours]:\r\n* >= 126 mg/dL for those patients without a pre-existing diagnosis of type 2 diabetes mellitus\r\n* >= 167mg/dL for those patients with a pre-existing diagnosis of type 2 diabetes mellitus

Fasting glucose =< 126 mg/dL (7.0 mmol/L)

Fasting plasma glucose < 140 mg/dL/7.8 mmol/L

Fasting serum glucose (=< 130 mg/dL)

Fasting triglycerides =< 300 mg/dL

Serum 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 allowed

Random 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 age

Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)

Fasting glucose under control (< 150 mg/dL [8.3 mmol/L])

Triglycerides < 250 mg/dL

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 can only be included after initiation of appropriate lipid lowering medication

Uncontrolled 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 eligibility

Poorly-controlled diabetes mellitus, as defined as fasting serum glucose concentration over 200 mg/dl or glycated hemoglobin (A1C) over 7.5%.

=< 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 medication

Uncontrolled diabetes as defined by fasting serum glucose > 1.5x ULN

Fasting 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.

Uncontrolled 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.

Fasting plasma glucose < 140 mg/dL / 7.7 mmol/L and glycosylated hemoglobin (HbA1c) =< 8% (both criteria have to be met)

Fasting 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 achieved

Normal blood glucose for age

Glycated hemoglobin (Hb A1c) =< 5.7%, or 5.8-6.5% with a normal fasting glucose

Patients 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 therapy

Fasting serum cholesterol =< 300 mg/dL

Fasting triglyceride =< 2.5 x ULN

Metabolic status: HbA1c < 7.0%, fasting serum glucose ? 130 mg/dL, and fasting triglycerides ? 300 mg/dL.

Glucose, serum < 200 mg/dL

Fasting cholesterol =< 1.5 x ULN

Hyperglycemia (fasting) ? Grade 2

Fasting plasma glucose (FPG) =< 160 mg/dL or 7.8 mmol/L

Diagnosis 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%

Patients with uncontrolled diabetes or fasting blood glucose > 200 mg/dL may enroll but will not be evaluable for PET imaging

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 can only be included after initiation of appropriate lipid lowering medication

Fasting serum glucose (=< 130 mg/dL)

Fasting triglycerides =< 300 mg/dL

The following metabolic values will exclude patients from study enrollment: \r\n* Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels\r\n* Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels; Note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (eg, magnesium oxide) at the investigator’s discretion\r\n* Potassium < 3.5 mmol/L or > 6 mmol/L despite intervention to normalize levels\r\n* Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels

Poorly 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 physicians

Diabetes must be controlled prior to PET-CT scanning (blood glucose < 200 mg/dL)

Fasting serum triglyceride level =< 500 mg/dL

Fasting glucose within normal limits

Fasting plasma glucose =< 200 mg/dL

Obtained =< 14 days prior to registration: Fasting serum glucose =< 1.5 x ULN

Fasting serum glucose =< 130 mg/dL.

Fasting triglycerides =< 300 mg/dL.

Significant electrolyte imbalance prior to enrollment (note that patients may be supplemented to achieve acceptable electrolyte values):\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/L

Fasting blood glucose (FBG) < 130 mg/dL

Severe and uncontrolled Cushing syndrome despite medical management (e.g., systolic blood pressure > 160 mmHg or hyperglycemia with fasting glucose above 300 mg/dL).

Fasting or random blood glucose within the upper limits of normal for age

If random blood glucose is above upper limits for age, a fasting blood glucose can be obtained and must be within normal limits for age

Fasting or non-fasting serum triglyceride level =< 300 mg/dL and serum cholesterol level =< 300 mg/dL

Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL).

Uncontrolled hypertriglyceridemia (triglycerides > 450mg/dL).

Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)

Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)

Patients must have a serum calcium of >= 2.0 mmol/L (8.0 mg/dL) or albumin-adjusted serum calcium =< 2.9 mmol/L (11.5 mg/dL) within 30 days of registration; (Note: if patients are undergoing treatment for hypocalcemia and the serum calcium value at screening is > 8.0 mg/dl, then the patient will be eligible for this study)

Only 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.

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 can only be included after initiation of appropriate lipid lowering medication

Cholesterol =< 300 mg/dL

Fasting serum glucose < 130 milligram per deciliter (mg/dL) and fasting triglycerides <= 300 mg/dL.

Fasting serum glucose (=< 130 mg/dL)

Fasting triglycerides =< 300 mg/dL

Fasting serum glucose =< 130 mg/dL

Fasting triglycerides =< 300 mg/dL

Fasting glucose =< 160 mg/dL (CTCAE grade 1 baseline)

Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)

History 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 visit

Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)

Fasting serum glucose (=<130 mg/dL)

Fasting triglycerides =< 300 mg/dL

Metabolic: fasting serum glucose (=< 130 mg/dL)

Metabolic: fasting triglycerides =< 300 mg/dL

Glycosylated hemoglobin (HbA1c) > 8.5% or fasting plasma glucose > 160 mg/dL at screening

Fasting serum glucose (=< 130 mg/dL)

Fasting triglycerides =< 300 mg/dL

CERITINIB INCLUSION CRITERIA: Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)

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 can only be included after initiation of appropriate lipid lowering medication

Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)

Fasting serum glucose =< 130 mg/dL

Fasting triglycerides =< 300 mg/dL

History of Type 1 or 2 diabetes mellitus requiring regular medication (other than oral hypoglycemic agents including metformin) or fasting glucose ? 160 mg/dL

Glucose >= 80 mg/dL

For 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/mol

For patients with type II diabetes receiving only oral anti-hyperglycemic therapy (patients receiving insulin are not eligible), the following are required at screening:\r\n* HbA1c < 8.5 % or IFCC < 69.4 mmol/mol\r\n* Stable regimen of oral anti-hyperglycemic therapy without insulin usage for at least 3 weeks prior to first study treatment\r\n* Fasting plasma glucose levels =< 160 mg/dL (8.88 mmol/L) and no hypoglycemia (blood sugar [BS] < 60) during home monitoring for at least 1 week prior to study entry

Fasting 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 medication

Serum cholesterol and serum triglyceride levels must be less than 300 mg/dl

Serum calcium (ionized or adjusted for albumin) < 8 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels

Magnesium < 1.4 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels

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 can only be included after initiation of appropriate lipid lowering medication

Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)

Have uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)

Serum triglycerides < 300mg/dL fasting or on a random plasma test

Fasting serum glucose =< 130 mg/dL

Fasting triglycerides =< 300 mg/dL

Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)

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 can only be included after initiation of appropriate lipid lowering medication with confirmed reduction of lab values to within eligibility parameters

Glucose < 200 mg/dL

Known diabetes (type 1 or 2), fasting glucose > or equal to 7.0 mmol/L (126 mg/dL), or HgbA1C > 6.5

Fasting level of total cholesterol of no more than 350 mg/dL

Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)

Poorly controlled diabetes, fasting blood sugar (FBS) >= 200 mg/dL

Uncontrolled 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%

Within 4 weeks of preregistration: Blood glucose =< 126 mg/dL fasting or =< 140 mg/dL nonfasting

ELIGIBILITY 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)

EXCLUSION 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 eligibility

Fasting 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 medication

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

Fasting 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 parameters

Fasting 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 function

Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L) (Gedatolisib can cause hyperglycemia)

Fasting plasma glucose =< 120 mg/dL

Fasting plasma glucose (FPG) =< 140 mg/dL or =< 7.8 mmol/L

Fasting plasma glucose (FPG) =< 140mg/dL or =< 7.8 mmol/L

Patient has fasting plasma glucose (FPG) ?140 mg/dL (7.7 mmol/L) and glycosylated hemoglobin (HbA1c) ? 6.4% (both criteria have to be met)

Fasting triglyceride =< 200 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)

Fasting cholesterol =< 240 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)

Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels

Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14mmol/L)

Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels

TREATMENT: 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-off

TREATMENT: 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 discretion

Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels

Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L)

Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels

Fasting cholesterol less than or equal to 300 mg/dl; fasting triglycerides less than or equal to 300 mg/dl

Patients with uncontrolled diabetes mellitus (fasting blood glucose controlled by medication, =< 200 mg/dL allowed)

Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v]. 4):\r\n* Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl\r\n(> 3.1 mmol/L) despite intervention to normalize levels\r\n* Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels\r\n* Potassium < 3.5 mmol/L or > 6 mmol/L despite intervention to normalize levels\r\n* Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels

Uncontrolled diabetes (if random blood sugar > 200 mg/dL, perform fasting blood sugar to ensure < 200 mg/dL)

Serum 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)

Subjects 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.

Fasting 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 recommended

Fasting glucose < 125 mg/dL obtained within 28 days prior to sub-study registration

Fasting glucose < 125 mg/dL obtained within 28 days prior to Step 2 re-registration

Fasting glucose =< 120 mg/dL

Within 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)

Significant 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/L

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 can only be included after initiation of appropriate lipid lowering medication

Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN

Fasting blood glucose =< 125 mg/dL within 14 days prior to registration

Fasting plasma glucose (FPG) =< 140 mg/dL

Metabolic: fasting serum glucose (=< 130 mg/dL) and fasting triglycerides =< 300 mg/dL

Fasting serum glucose < 126 mg/dl (7 mmol/l)

Fasting glucose < 160 mg/dL

Patients 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 screening

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 can only be included after initiation of appropriate lipid lowering medication

Baseline cholesterol must be < 350 mg/dL and triglycerides < 300 mg/dL (with or without the use of antihyperlipidemic medications)

Baseline fasting blood glucose must be =< 140 mg/dL and hemoglobin A1c less than 7.5% (with or without the use of anti-diabetic medications)

Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications

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 can only be included after initiation of appropriate lipid lowering medication

Patient has uncontrolled diabetes, defined as a fasting serum glucose > 150 mg/dl or glycosylated hemoglobin (hemoglobin A1c [HbA1c]) > 7% at screening

Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)

Normal fasting glucose

Diabetes 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 results

Adequate 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 investigator

Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN

Fasting 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 intake

Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L

Fasting triglycerides =< 300 mg/dL or =< 1.71 mmol/L

Fasting glucose value ? 160 mg/dL (CTCAE Grade 1 baseline)

Patients 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 treatment

Patients 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 treatment

Uncontrolled diabetes, as evidenced by fasting serum glucose level >200 mg/dL

Corrected serum calcium >13.5 mg/dL (> 3.4 mmol/L)

Severe, active co-morbidity, defined as follows:\r\n* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration\r\n* Transmural myocardial infarction within 6 months prior to registration\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\r\n* Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration\r\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol\r\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients\r\n* Grade 3-4 electrolyte abnormalities (CTCAE, v. 4):\r\n** Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels\r\n** Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L)\r\n** Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels\r\n** Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels\r\n** Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels

Fasting serum triglyceride level =< 500 mg/dL

Fasting 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 achieved

Glucose =< 2 x ULN

CTCAE version (v)4.0 grade 3-4 electrolyte abnormalities:\r\n* Calcium < 7 mg/dl or > 12.5 mg/dl;\r\n* Glucose < 40 mg/dl or > 250 mg/dl;\r\n* Magnesium < 0.9 mg/dl or > 3 mg/dl;\r\n* Potassium < 3 mmol/L or > 6 mmol/L;\r\n* Sodium < 130 mmol/L or > 155 mmol/L

Screening fasting lipid panel: LDL cholesterol < 190 mg/dL, triglycerides < 300 mg/dL

Glycosylated hemoglobin (HbA1c) less than (<) 7.0%, fasting serum glucose <=130 milligram per deciliter (mg/dL), and fasting triglycerides <=300 mg/dL.

Fasting serum cholesterol less than or equal to 300 mg/dL

Fasting triglycerides less than or equal to 300 mg/

Fasting 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:

Serum triglyceride level =< 300 mg/dL (=< 3.42 mmol/L)

Serum cholesterol level =< 300 mg/dL (7.75 mmol/L)

Random 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 age

Grade ?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.

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 can only be included after initiation of appropriate lipid lowering medication

Fasting 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.

Patients 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)

Fasting plasma glucose (FPG) =< 120 mg/dL or =< 6.7 mmol/L

Fasting serum glucose =< 130 mg/dL

Fasting triglycerides =< 300 mg/dL

Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)

Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)

Fasting 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 medication

Patient has: random glucose > 200 mg/dl or is taking an oral hypoglycemic agent or insulin at the time of study entry

Fasting 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 medications

Fasting glucose < 140 mg/dL

Baseline fasting glucose of < 126 mg/dl (7 mmol/L)

Known diabetes (type 1 or 2) or baseline fasting glucose >= 126 mg/dl (7 mmol/L)

Significant electrolyte imbalance prior to enrollment (note that patients may be supplemented to achieve acceptable electrolyte values):\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/L

Fasting plasma glucose (FPG) < 140 mg/dL/7.8 mmol/L, where fasting is defined as no food intake for 8 hours prior to measurement

Type 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 excluded

Cholesterol level =< 350 mg/dl; fasting is not required before testing, but if elevated without fasting, repetition with fasting can be performed to determine eligibility

Triglycerides level =< 400 mg/dl; fasting is not required before testing, but if elevated without fasting, repetition with fasting can be performed to determine eligibility

Patients 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 values

Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)

Serum phosphate levels >= 2.5 mg/dL or >= 0.8 mmol/L

Fasting 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 ULN

Diabetes 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%

Fasting glucose < 120 mg/dL

Patients 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 enrollment

At least 4 weeks (28 days) prior to registration: Fasting plasma glucose (FPG) < 140 mg/dL/7.8 mmol/L

Normal fasting cholesterol and triglycerides

Fasting glucose < 250 mg/dL; patients with diabetes are allowed to participate, provided that their blood glucose is < 250 mg/dL upon enrollment

Fasting blood glucose within institutional normal limits

Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)

Additional 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 range

PART B: Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)

Fasting serum cholesterol =< 300 mg/dl OR =< 7.75 mmol/l AND fasting triglycerides =< 2.5 times ULN*

Uncontrolled diabetes, as defined by fasting serum glucose > 1.5 times ULN*

Fasting 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 intake

Uncontrolled 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/dL

Plasma phosphate >= 2.3 and < 4.8 mg/dL

Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L), if not consider initiation of metformin treatment prior to study treatment

Fasting 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 medication

Obtained within 2 weeks from study entry: Fasting plasma glucose =< 140 mg/dL

Patients 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 medications

Patients 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 medications

Cholesterol > 300 mg/dl or triglycerides > 400 mg/dl despite treatment

Patient must have a calcium phosphate product (CPP) =< 4.0 mmol^2/L^2 or 50 mg^2/dL^2

Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at screening.

Patients 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/dl

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 can only be included after initiation of appropriate lipid lowering medication

Fasting 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 medication

Known uncontrolled hyperlipidemia defined as LDL-C >= 190 mg/dL or triglycerides >= 500 mg/dL

Fasting 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 medication

History of diabetes requiring treatment, glucose >126 mg/dL, Glycated hemoglobin (HbA1c) ?6.5%

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 only be included after initiation of appropriate lipid lowering medication

ARM 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/dL

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 can only be included after initiation of appropriate lipid lowering medication

Cholesterol =< 350 mg/dL

Triglycerides =< 400 mg/dL (sirolimus and hydroxychloroquine only)

Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)

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 medication

EXPANSION 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 medication

f. Poorly controlled diabetes (fasting blood glucose > 180 mg/dL)

Fasting 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 medication

Uncontrolled 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

Fasting level of total cholesterol of no more than 350 mg/dL

Fasting serum glucose =< 150 mg/dl (fasting is defined as at least 8 hours without oral intake)

Fasting blood glucose of ? 140 mg/dL (7.8 mmol/L).

Serum calcium or albumin-adjusted serum calcium ? 2.0 mmol/L (8.0 mg/dL) and ? 2.9 mmol/L (11.5 mg/dL)

Magnesium >= 1.2mg/dL or 0.5 mmol/L

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 (for fasting serum cholesterol or triglyceride) are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication

Fasting blood glucose of ? 140 mg/dL (7.8 mmol/L).

Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)

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 can only be included after initiation of appropriate lipid lowering medication

Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with Fasting Plasma Glucose (FPG) ? 140 mg/dL / 7.8 mmol/L

Uncontrolled (? Grade 2) hypertriglyceridemia (fasting triglycerides > 300 mg/dL (3.42 mmol/L))

Fasting plasma glucose > 120mg/dL or > 6.7 mmol/L

Patient does not have uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL)

Patient with diabetes mellitus: fasting glucose =< 120 mg/dL and hemoglobin A1c (HbA1c) =< 8%

Fasting glucose of ?126 mg/dL (7.0 mmol/L).

Hyperglycemia (fasting) >= Grade 2

Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)

For 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%

Fasting serum glucose =< 130 mg/dL

Uncontrolled diabetes mellitus (fasting plasma glucose > 130 mg/dL)

Fasting 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 medication

Glycated hemoglobin (HgbA1c) ? 7 %; Fasting Plasma Glucose (FPG) ? 7.0 mmol/L (125 mg/dL).

Fasting glucose > 7.0 mmol/L (126 mg/dL). or HbA1c > 6.4%.

Fasting glucose less than or equal to (</=) 125 milligrams per deciliter (mg/dL)

Serum fasting triglyceride level =< 300 mg/dL (=< 3.42 mmol/L) and serum cholesterol level =< 300 mg/dL (=< 7.75 mmol/L)

Fasting glucose < 140 mg/dL (7.8 mmol/L).

Fasting plasma glucose < 8.9 mmol/L (< 160mg/dL) and HbA1C < 8%

Patients 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 screening

Fasting plasma glucose (FPG) ? 120 mg/dL or ? 6.7 mmol/L

Subjects with fasting glucose >125 mg/dL in 2 independent measurements or glycated hemoglobin (HbA1c) ? 7%

Fasting 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 medication

Fasting serum glucose < 1.5 x ULN obtained =< 7 days prior to registration

Fasting 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 medication

Poorly controlled diabetes as defined by a fasting serum glucose > 2.0 x ULN.

fasting serum cholesterol ?300 mg/dL OR ?7.75 mmol/L AND fasting triglycerides ?2.5 x ULN.

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN

Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)

Fasting glucose =< 150 mg/dL

Fasting cholesterol level < 350 mg/dl

Fasting triglycerides =< 300 mg/dl

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 can only be included after initiation of appropriate lipid lowering medication

If diabetic and taking insulin or oral anti-diabetic therapy, must have hemoglobin A1c (HbA1c) =< 8%, or a fasting serum glucose =< 110% ULN

Fasting plasma glucose (FPG) =< 120 mg/dL or 6.7 mmol/L

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 only be included after initiation of appropriate lipid lowering medication

Serum magnesium greater than the LLN and < 3.0 mg/dL or 1.23 mmol/L

The participant has fasting serum glucose less than or equal to 125 mg/dL, and hemoglobin A1C less than or equal to 6%.

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 only be included after initiation of appropriate lipid lowering medication

Current diagnosis of type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, or HbA1c 7%

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 can only be included after initiation of appropriate lipid lowering medication

Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN

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 can only be included after initiation of appropriate lipid lowering medication

The 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 required

Fasting serum glucose (=< 130 mg/dL)

Fasting triglycerides =< 300 mg/dL

Fasting 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 acceptable

Fasting plasma glucose < 120 mg/dL

Fasting 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.

Uncontrolled 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.

Fasting glucose < grade 2 (=< 160 mg/dL or =< 8.9 mmol/L) without the use of antihyperglycemic agents

Free 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 clearance

Diabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dL

NON-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)

Fasting plasma glucose =< 130 mg/dL (or 7.2 mmol/L)

Fasting triglycerides =< 300 mg/dL (3.42 mmol/L)

Cholesterol =< 300 mg/dL (7.75 mmol/L)

Patients with poorly controlled diabetes mellitus with fasting serum glucose concentration over 200 mg/dl or a hemoglobin A1C over 7.5%.

Uncontrolled hyperglycemia as defined by any blood glucose of > 300 mg/dl in the past two weeks

Serum calcium or albumin-adjusted serum calcium 2.0 mmol/L (8.0 mg/dL) and 2.9 mmol/L (11.5 mg/dL)

Random glucose < 160 mg/dL or fasting glucose < 126 mg/dL (other values require workup to rule out undiagnosed diabetes that may require treatment)

Currently 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)

Patients 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 old

Patients with fasting capillary blood glucose of > 140 on the day of surgery

Fasting blood glucose =< 120 mg/dL

Fasting blood glucose level > 126 and glycosylated hemoglobin (HbA1c) > 7%.

Triglycerides =< 150 mg/dl

Fasting cholesterol > 300 mg/dl or triglycerides > 300 while on lipid lowering agents

Non-fasting blood glucose >= 200 mg/dL, or hemoglobin A1C (HbA1C) >= 7%

Fasting blood glucose =< 115 mg/dL

It 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 eligibility

It 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 eligibility

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 can only be included after initiation of appropriate lipid lowering medication

Fasting serum glucose =< 130 MG/DL

Fasting plasma glucose < 140 mg/dL/7.7 mmol/L

12 hour fasting glucose level < 7.0 mmol/L

No known diabetes (type 1 or 2) or baseline fasting glucose >= 7.0 mmol/L

Not frankly diabetic, as measured by a fasting blood glucose =< 126 mg/dL

Triglycerides (fasting) >= 400

Type I or II diabetes; documented fasting plasma glucose > 125 mg/dL, current exposure to antidiabetic medications, including insulin

Fasting cholesterol =< 1.5 x ULN

Glucose within 2 x ULN

Plasma glucose =< 200 mg/dL

Plasma glucose > 200 mg/dL

Blood glucose > 200

Have plasma triglycerides < 200 mg/dL

Have plasma total cholesterol > 200 mg/dL or plasma triglycerides > 200 mg/dL

Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)

Uncontrolled diabetes or blood glucose > 175 mg/dl on the day of the FDG-PET scan

Patients with diabetes mellitus, with uncontrolled fasting blood glucose level (above 200 mg/dl)

Severe diabetes (fasting blood glucose > 200 mg/dl)

Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)

Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)

Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)

Patient 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 medications

Blood 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 study

Patient must not be an uncontrolled diabetic with a glucose of >= 200 mg/dl at the time of PET imaging

Patients 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)

Uncontrolled diabetes or blood glucose > 180 mg/dl on the day of the fludeoxyglucose F 18 ([18F]FDG)-PET scan

Uncontrolled hyperglycemia (defined as inability to achieve a glucose of < 250 mg/dL at time of FDG injection)

Blood glucose of < 80 mg/dL or > 150 mg/dL

Uncontrolled diabetes with a fasting glucose >= 200 mg/dl at the time of PET/MRI imaging

Serum glucose > 200 mg/dL

Fasting glucose > 200 mg/dL or

Fasting triglycerides > 300 mg/dL

Fasting serum glucose ?130 mg/dL and fasting triglycerides ?300 mg/dL.