Fasting cholesterol =< mg/dL and triglycerides =< . x IULN obtained within days prior to registration; patients may be on lipid lowering agents to reach these values
Baseline fasting triglycerides > . IULN or hypertriglyceridemia requiring medication; patients requiring medication for other dyslipidemias (i.e., elevated low-density lipoprotein [LDL] cholesterol) are eligible
Patients must have a fasting LDL cholesterol within the normal range per institutional guidelines
Fasting total cholesterol ? mg/dL (or ?. millimoles [mmol]/L) and/or fasting triglycerides level ?. the ULN. Note: these participants can be included after initiation or adjustment of lipid-lowering medication.
Fasting triglyceride =< . x ULN
Fasting cholesterol =< . x ULN
Hyperglycemia (fasting) ? Grade
Only for subjects enrolled in Arm - Neratinib and everolimus: fasting lipid profile: cholesterol less than or equal to mg/dL and triglycerides less than or equal to mg/dL.
Fasting triglyceride =< mg/dL; ONLY APPLICABLE for patients with NF mutation (GSK)
Fasting cholesterol less than or equal to mg/dl; fasting triglycerides less than or equal to mg/dl
Serum triglyceride =< mg/dL (applicable only for dose levels that include isotretinoin) (note that a non-fasting triglyceride value could be obtained, if this is > mg/dL then a fasting triglyceride should be obtained and patient will be eligible if the fasting level is =< mg/dL)
Patients must not have uncontrolled hyperlipidemia (fasting serum cholesterol > mg/dL AND fasting triglycerides > . x ULN) obtained within days prior to registration; optimal lipid control must be achieved before registration and monitored during protocol treatment
Screening fasting lipid panel: LDL cholesterol < mg/dL, triglycerides < mg/dL
Cholesterol level =< mg/dl; fasting is not required before testing, but if elevated without fasting, repetition with fasting can be performed to determine eligibility
Triglycerides level =< 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 =< mg/dl OR =< . mmol/L and triglycerides =< . x IULN obtained within days prior to registration; patients may be on lipid lowering agents to reach these values
Fasting serum cholesterol less than or equal to mg/dL OR less than or equal to . mmol/L AND fasting triglycerides less than or equal to . x ULN
Normal fasting cholesterol and triglycerides
Fasting serum cholesterol =< mg/dl OR =< . mmol/l AND fasting triglycerides =< . times ULN*
Patients with fasting serum cholesterol > mg/dL OR > . mmol/L AND fasting triglycerides > . x upper limit of normal (ULN) should initiate lipid lowering medications
Patients with fasting serum cholesterol > mg/dL OR > . mmol/L AND fasting triglycerides > . x ULN who would need to initiate lipid lowering medications
Fasting total cholesterol > milligram per deciliter (mg/dL) (or ?. millimole per liter (mmol/L)) and/or fasting triglycerides level ?. x upper limit of normal (ULN). Note: these subjects can be included after initiation or adjustment of lipid-lowering medication
Hyperglycemia (fasting) >= Grade
fasting serum cholesterol ? mg/dL OR ?. mmol/L AND fasting triglycerides ?. x ULN.
Fasting total cholesterol ? milligrams (mg)/dL (or ?. millimoles [mmol]/L) or fasting triglycerides level ?. ULN. Note: these participants can be included after initiation or adjustment of lipid-lowering medication.
Fasting cholesterol > mg/dl or triglycerides > while on lipid lowering agents
It is recommended the lipid profile be drawn fasting >= hrs; serum lipid profile: total cholesterol/high-density lipoprotein (HDL)/low-density lipoprotein (LDL)/triglycerides (LDL levels prior to chemotherapy must be =< mg/dl), within days prior to enrollment\r\n* If labs are drawn non-fasting and LDL levels are >= mg/dl the lipid profile should be repeated fasting to determine eligibility
Fasting cholesterol =< . x ULN