Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic congestive heart failure of New York heart Association Class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Severely impaired lung function as defined as spirometry and diffusion capacity of the lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or oxygen (O2) saturation that is 89% or less at rest on room air\r\n* Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic congestive heart failure of New York heart Association class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Severely impaired lung function as defined as spirometry and carbon monoxide diffusing capability test (DLCO) that is 50% of the normal predicted value and/or oxygen (O2) saturation that is 89% or less at rest on room air\r\n* Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis\r\n* Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Patients who have any severe and/or uncontrolled medical conditions such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus\r\n* Serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection,\r\n* Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA])\r\n* Known severely impaired lung function (spirometry and diffusion capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease\r\n* Known severely impaired lung function\r\n* Corrected QT (QTc) interval > 450 msec for males or > 470 msec for females\r\n* Active, bleeding diathesis\r\n* Psychiatric illness/social situations that would preclude informed consent, limit compliance with study requirements
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Severely impaired lung function as defined as spirometry and diffusion capacity of the lungs for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or oxygen (O2) saturation that is 90% or less at rest on room air\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)
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: a) Symptomatic congestive heart failure of New York heart Association class III or IV; b) Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease; c) Severely impaired lung function as defined as oxygen (O2) saturation that is 92% or less at rest on room air; d) Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN; e) Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment; f) Known active or symptomatic viral hepatitis or chronic liver disease. Uncontrolled adrenal insufficiency.
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study including:\r\n* Symptomatic congestive heart failure of New York heart Association class III or IV\r\n* Unstable angina pectoris, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Severely impaired lung function with a previously documented spirometry and Carbon Monoxide Diffusing Capability Test (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air\r\n* Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis\r\n* A known history of human immunodeficiency virus (HIV) seropositivity as reported by the patient\r\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of EVE (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)\r\n* Patients with an active, bleeding diathesis\r\n* Active or latent, untreated hepatitis B or C; a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) DNA and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: symptomatic congestive heart failure of New York Heart Association class III or IV; unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease; severely impaired lung function as defined as oxygen (O2) saturation that is 88% or less at rest on room air; uncontrolled diabetes as defined by blood glucose > 200 mg/dl (11.1 mmol/l); systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment; liver disease such as cirrhosis or chronic active hepatitis; positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection
Patient who has any severe and/or uncontrolled medical conditions such as: \r\n* Active or uncontrolled severe infection,\r\n* Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA]) and/or positive hepatitis B virus surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA])\r\n* Known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active bleeding diathesis\r\n* Uncontrolled arterial hypertension defined by blood pressure > 170/100 mm Hg at rest (average of 3 consecutive readings 5 min apart)\r\n* Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; examples of uncontrolled medical conditions include:\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e. quantifiable Hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive Hepatitis B surface antibody [HbsAg], quantifiable Hepatitis C virus [HCV]-ribonucleic acid [RNA])\r\n* Known severely impaired lung function (spirometry and diffusing capacity of the lungs for carbon monoxide (DLCO) 50% or less of normal and O2 saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions such as: a. serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease b. active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive surface antigen of the hepatitis B virus [HBsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]), c. known severely impaired lung function (spirometry and Diffusing capacity of the lungs for carbon monoxide [DLCO] 50% or less of normal and oxygen (O2) saturation 88% or less at rest on room air), d. active, bleeding diathesis; e. Moderate or severe hepatic impairment (Child-Pugh B or C)
Patients who have any severe and/or uncontrolled medical conditions such as: \r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus test [hepatitis B virus (HBV)-deoxyribonucleic acid (DNA)] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus test [hepatitis C virus (HCV)-ribonucleic acid (RNA)])\r\n* Known severely impaired lung function (spirometry and carbon monoxide diffusing capacity [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months prior to registration, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Severely impaired lung function as defined as spirometry and diffusion capacity of carbon monoxide (DLCO) that is less than 50% of the normal predicted value and/or oxygen (O2) saturation that is 88% or less at rest on room air\r\n* Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN (Note: optimal glycemic control should be achieved before starting everolimus)\r\n* Active (acute or chronic) or uncontrolled severe infections
Patients who have any severe and/or uncontrolled medical conditions such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York heart Association class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B virus surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA])\r\n* Known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: symptomatic congestive heart failure of New York heart Association class III or IV unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug or any other clinically significant cardiac disease severely impaired lung function as defined as spirometry and diffusing capacity of the lungs for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or oxygen (O2) saturation that is 88% or less at rest on room air uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN, active (acute or chronic) or uncontrolled severe infections, liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Severely impaired lung function as defined as spirometry and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% of the normal predicted value and/or oxygen (O2) saturation that is 88% or less at rest on room air\r\n* Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN (Note: optimal glycemic control should be achieved before starting trial therapy)\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as hepatitis B/C, cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n* Blood test indicates hepatitis B/C (Hep B/C) positive or human immunodeficiency virus (HIV) positive\r\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)\r\n* Patients with an active, bleeding diathesis\r\n* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using 2 effective and reliable birth control methods; adequate protection must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)\r\n* Male patient whose sexual partner(s) are women of child-bearing potential who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment\r\n* Patients who have received prior treatment with a mammalian target of rapamycin (mTOR) inhibitor (e.g., sirolimus, temsirolimus, everolimus)\r\n* Patients with a known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients\r\n* History of noncompliance to medical regimens\r\n* Patients unwilling to or unable to comply with the protocol
TUMOR BIOPSY SEQUENCING: Patients with uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the past 6 months, invasive fungal infections, or active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e., quantifiable hepatitis B virus [HBV]-DNA and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) are not eligible to participate; testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated
TREATMENT: Patients with uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the past 6 months, invasive fungal infections, or active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e., quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) are not eligible to participate; testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic congestive heart failure of New York heart Association class III or IV \r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia, left ventricular ejection fraction (LVEF) < 50% or any other clinically significant cardiac disease\r\n* Severely impaired lung function as defined as spirometry and diffusion capacity of the lung of carbon monoxide (DLCO) that is 50% of the normal predicted value and/or oxygen (02) saturation that is 88% or less at rest on room air\r\n* Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN (Note: optimal glycemic control should be achieved before starting trial therapy)\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* Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C ribonucleic acid polymerase chain reaction (HCV RNA PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection; patients with positive results for HBV/HCV infection will be allowed in this study provided monitoring and prophylactic treatment are followed
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n** Note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia\r\n* Severely impaired lung function\r\n* Active (acute or chronic) or uncontrolled infection\r\n* Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy\r\n* Liver disease (i.e. cirrhosis, chronic active hepatitis, chronic persistent hepatitis)
Patients who have any severe and/or uncontrolled medical conditions such as: a) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease; b) symptomatic congestive heart failure of New York Heart Association class III or IV; c) active (acute or chronic) or uncontrolled severe infection (not responding to antibiotics), liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e. quantifiable hepatitis B virus-deoxyribonucleic acid [HBV-DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus-ribonucleic acid [HCV-RNA]); d) known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air); e) active, bleeding diathesis
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure of New York Heart Association (NYHA) class III or IV, active coronary artery disease, unstable angina pectoris, cardiac arrhythmia, myocardia infraction =< 6 months prior to start of everolimus, uncontrolled hypertension (systolic pressure > 150 mmHg or diastolic pressure > 90 mmHg), uncontrolled seizure disorder, liver disease such as cirrhosis, decompensated liver disease, active and chronic hepatitis, known severely impaired lung function (spirometry and diffusing capacity of the lungs for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air), active bleeding diathesis, or psychiatric illness/social situations that would limit compliance with study requirements
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens including but not limited to any of the following that would limit compliance with study requirements:\r\n* Ongoing or active severe infection\r\n* Liver disease such as cirrhosis\r\n* Decompensated liver disease\r\n* Symptomatic congestive heart failure (New York heart Association class III or IV)\r\n* Unstable angina pectoris, serious uncontrolled cardiac arrhythmia, myocardial infarction =< 6 months prior to registration\r\n* Known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active bleeding diathesis\r\n* Psychiatric illness
Patients who have any severe and/or uncontrolled medical conditions such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York heart Association class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis or decompensated liver disease, and chronic hepatitis\r\n* Known severely impaired lung function (spirometry and diffusion capacity of carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions such as: a) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction less than or equal to 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease; b) symptomatic congestive heart failure of New York Heart Association class III or IV; c) active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]); d) known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air); e) active, bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B virus surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA])\r\n* Known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: symptomatic congestive heart failure of New York Heart Association class III or IV; unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease; severely impaired lung function as defined as spirometry and diffusing capacity of the lungs for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or oxygen (O2) saturation that is 88% or less at rest on room air; active (acute or chronic) or uncontrolled severe infections; liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C); note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection; a known history of human immunodeficiency virus (HIV) seropositivity; impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection); patients with an active, bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic congestive heart failure of New York heart Association Class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Severely impaired lung function as 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% or less at rest on room air\r\n* Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN\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* Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Unstable angina pectoris (at any time), symptomatic congestive heart failure (New York Heart Association [NYHA] III, IV) (at any time), serious uncontrolled cardiac arrhythmia (at any time), myocardial infarction, cerebrovascular accidents, or symptomatic left ventricular dysfunction =< 6 months prior to first study treatment\r\n* Active bleeding diathesis\r\n* Known severely impaired lung function defined as spirometry and diffusion capacity of the lung for carbon monoxide (DLCO) =< 50% of normal oxygen saturation at rest =< 88% on room air\r\n* Symptomatic intrinsic lung disease requiring oxygen supplementation at baseline\r\n* Uncontrolled diabetes mellitus as defined by glycosylated hemoglobin (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary\r\n* Any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study\r\n* Liver disease such as cirrhosis or decompensated liver disease, or active and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HBsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA])
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Severely impaired lung function (as defined as spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] that is 50% of the normal predicted value and/or oxygen [02] saturation that is 88% or less at rest on room air)\r\n* Any active (acute or chronic) or uncontrolled infection/disorders\r\n* Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy\r\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (everolimus)\r\n* Patients who have a history of drug abuse in the 6 month period prior to receiving treatment with pasireotide or RAD001\r\n* History of, or current alcohol misuse/abuse within the past 12 months\r\n* Acute or chronic pancreatitis
Patients who have any severe and/or uncontrolled medical conditions such as: \r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-DNA and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA])\r\n* Known severely impaired lung function (e.g. spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis
Any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety, obtaining informed consent or compliance to study procedures; examples of such include uncontrolled diabetes, nonhealing wound, severe or uncontrolled infection, severe malnutrition, severely impaired lung function as defined as spirometry and diffusion capacity of carbon monoxide (DLCO) that is 50% of the normal predicted value and/or oxygen (02) saturation that is 88% or less at rest on room air, ventricular arrhythmias, active ischemic heart disease, chronic liver or renal disease, or active upper GI tract ulceration
EXPANSION COHORT ONLY: Any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety, obtaining informed consent or compliance to study procedures\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ?6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, ventricular arrhythmias, active ischemic heart disease, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York heart Association Class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection \r\n* Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA)\r\n* Known severely impaired lung function (e.g. spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air)active, bleeding diathesis \r\n* Severe or uncontrolled infection, severe malnutrition\r\n* Chronic renal disease\r\n* Active upper GI tract ulceration
Patients who have any severe and/or uncontrolled medical conditions such as: \r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e quantifiable hepatitis B virus [HBV]-DNA and/or positive hepatitis surface antigen [HbsAg], quantifiable hepatitis C virus[HCV]-ribonucleic acid [RNA])\r\n* Known severely impaired lung function (spirometry and diffusing capacity of the lungs for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Unstable angina pectoris, any history of congestive heart failure, any history of known myocardial infarction, uncontrolled cardiac arrhythmia\r\n* Severely impaired lung function\r\n* Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN, off medications\r\n* Any active (acute or chronic) or uncontrolled infection/disorders\r\n* Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy\r\n* Liver disease including a known history of viral hepatitis B or C, evidence of cirrhosis, chronic active hepatitis or chronic persistent hepatitis\r\n* A known history of human immunodeficiency virus (HIV) seropositivity\r\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (everolimus) (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: \r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Concomitant use of drugs with a risk of causing torsades de pointes\r\n* Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN; note: optimal glycemic control should be achieved before starting trial therapy\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis; note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n - Symptomatic congestive heart failure of New York heart Association Class III or IV \r\n - Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n - Severely impaired lung function\r\n - Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy)\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)
Patients who have any severe and/or uncontrolled medical conditions such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York heart Association class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B virus surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA])\r\n* Known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis
Patients who have any severe and/or uncontrolled medical conditions such as: \r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease\r\n* Symptomatic congestive heart failure of New York Heart Association class III or IV\r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA])\r\n* Known severely impaired lung function (spirometry and diffusion capacity of the lungs for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis