Subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:
Uncontrolled (over the last 30 days), clinically significant confounding medical conditions
Uncontrolled clinically significant arrhythmias.
Participant has clinically significant uncontrolled conditions.
Having clinically significant cardiac disease such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic CHF
Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
Serious arrhythmia,
Uncontrolled clinically significant arrhythmia, myocardial ischemia or congestive heart failure within the past 2 weeks, that is considered by the treating physician as a contraindication for initiation of chemotherapy;  discussion with the principal investigator is encouraged if further clarification is required
Absence of uncontrolled cardiac arrhythmia
Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
Uncontrolled clinically significant cardiac arrhythmia
History of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia
Subject has a clinically significant uncontrolled condition(s) s described in the protocol.
Clinically significant uncontrolled illness
Subjects with uncontrolled (over the last 30 days) clinically significant confounding medical conditions
Symptomatic arrhythmia
-  Participant has clinically significant uncontrolled condition(s) as described in the protocol.
History or evidence of current clinically significant uncontrolled arrhythmias
Subjects with uncontrolled (over the last 30 days) clinically significant confounding medical conditions
Uncontrolled cardiac arrhythmia
Clinically significant uncontrolled condition(s).
NYHA Class III or IV, uncontrolled hypertension, or clinically significant arrhythmia
Serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA
Significant cardiac arrhythmia
clinically significant symptomatic arrhythmia despite anti-arrhythmic therapy.
Clinically significant cardiovascular disease (e.g., uncontrolled or any NYHA Class 3 or 4 CHF, uncontrolled angina, history of MI, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
Clinically significant uncontrolled condition(s)
No arrhythmia interpreted by the study cardiologist to be clinically significant
Uncontrolled clinically significant arrhythmias
Symptomatic and/or serious uncontrolled arrhythmia
Uncontrolled cardiac arrhythmia
Serious uncontrolled cardiac arrhythmia.
Ongoing, significant , uncontrolled medical condition.
Any clinically significant and uncontrolled major medical condition
A history or evidence of current clinically significant uncontrolled arrhythmias;
Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrythmias classified as Lown III, IV or V.
Clinically significant and uncontrolled major medical condition(s) including but not limited to:
Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease
Uncontrolled clinically significant arrhythmia in last 6 months.
Any significant medical condition that would preclude them from exercising (e.g., congestive heart failure, angina, uncontrolled arrhythmia or other symptoms that indicate increased risk for an acute cardiovascular or respiratory event)
Clinically significant uncontrolled condition(s).
Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI)
Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI)
History of cardiac arrhythmia, controlled or uncontrolled, including ventricular and supraventricular arrhythmia
Patients must not have had a clinically significant cardiac event within 6 months before entry; or the presence of any other uncontrolled cardiovascular conditions that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
No cardiac arrhythmias within 182 days of registration
History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months;
History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias
EXCLUSION CRITERIA FOR REGISTRATION: History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias
Ventricular arrhythmias requiring continuous therapy, or
Known cardiac arrhythmias requiring medication.
Adequate cardiac function with left ventricular ejection fraction >= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease
Myocardial infarction in preceding 4 weeks; history of uncontrolled cardiac arrhythmias or family history of sudden cardiac death
Patients who have a history of significant cardiac disease, cardiac disease risk factors or uncontrolled arrhythmias are NOT eligible for either Stratum
No diagnosed arrhythmias
Symptomatic or uncontrolled arrhythmias
known uncontrolled arrhythmias (except sinus arrhythmia) in the past 24 weeks.
No uncontrolled arrhythmias or symptomatic cardiac disease
No uncontrolled arrhythmias or symptomatic cardiac disease
Uncontrolled arrhythmias
Research participant does not require pressor support and/or does not have symptomatic cardiac arrhythmias
Research participant requires pressor support and/or has symptomatic cardiac arrhythmias
Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V (Appendix F).
Not requiring pressor support, not having symptomatic cardiac arrhythmias
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Not requiring pressor support, not having symptomatic cardiac arrhythmias
Not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension
Cardiovascular: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension
Cardiovascular criteria: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension
Left ventricular ejection fraction >= 45%; no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease
Left ventricular ejection fraction >= 40%; no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease
current, serious, clinically significant cardiac arrhythmias as determined by the Investigator.
ENROLLMENT: Uncontrolled arrhythmias or uncontrolled symptoms of cardiac disease noted by screening history and physical. Patients with known cardiac dysfunction should have an ejection fraction (EF) > 40% documented by echocardiogram (ECHO).
Cardiac arrhythmias
History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
Subjects with a known history of severe and/or uncontrolled ventricular arrhythmias.
Patients with a known history of severe and/or uncontrolled ventricular arrhythmias
No history of ventricular arrhythmias or severe cardiac dysfunction
No history of uncontrollable supraventricular arrhythmias
History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening
Serious cardiac illness or medical condition including but not confined to: Uncontrolled arrhythmias (e.g. ventricular tachycardia, high-grade atrioventricular (AV)-block, supraventricular arrhythmias which are not adequately rate-controlled);
Subjects with a known history of severe and/or uncontrolled ventricular arrhythmias.
Not requiring pressor support, not having symptomatic cardiac arrhythmias
History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.
Subjects with a known history of severe and/or uncontrolled ventricular arrhythmias.
No currently unstable angina and/or uncontrolled cardiac arrhythmias
History of complex ventricular or supraventricular arrhythmias
Uncontrolled arrhythmias
Known history of severe and/or uncontrolled ventricular arrhythmias
Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
No uncontrolled arrhythmias or symptomatic cardiac disease
History of or evidence of clinically significant uncontrolled cardiac arrhythmias
Recent malignant cardiac arrhythmias – all except sinus arrhythmia within 24 weeks prior to screening
Known significant uncontrolled cardiac arrhythmias
Known, uncontrolled cardiac arrhythmias (except sinus arrhythmia) within the past 24 weeks
Adequate cardiac function with left ventricular ejection fraction at least 45% on appropriate medical therapy; no uncontrolled arrhythmias or symptomatic cardiac disease
History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
Patients with currently uncontrolled cardiac arrhythmias (non-sinus rhythm) will be excluded; patients with history of arrhythmias under pharmacological/pacemaker control will be allowed, except if receiving antiarrhythmic medication listed in “contra-indicated medications” below
Uncontrolled arrhythmias
Uncontrolled arrhythmias causing symptoms or hemodynamic compromise in the last week
Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease
History of cardiac arrhythmias
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Uncontrolled cardiac arrhythmias
Serious ventricular arrhythmias or high risk for arrhythmias, due to prolongation of the QT-interval (> 60 milliseconds [msec])
History of significant cardiac disease or uncontrolled arrhythmias
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:\r\n* Active cardiac disease\r\n** Angina pectoris that requires the current use of anti-anginal medication;\r\n** Ventricular arrhythmias except for benign premature ventricular contractions;\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\r\n** Conduction abnormality requiring a pacemaker;\r\n** Valvular disease with documented compromise in cardiac function; or\r\n** Symptomatic pericarditis\r\n* History of cardiac disease\r\n** Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricle (LV) function;\r\n** History of documented congestive heart failure (CHF); or\r\n** Documented cardiomyopathy
Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; or symptomatic pericarditis.
Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen; this includes but is not confined to: \r\n* Active cardiac diseases including: \r\n** Symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention\r\n** Ventricular arrhythmias except for benign premature ventricular contractions\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n** Conduction abnormality requiring a pacemaker\r\n** Valvular disease with documented compromise in cardiac function\r\n** Symptomatic pericarditis \r\n* History of cardiac disease:\r\n** Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function\r\n** History of documented congestive heart failure (CHF) \r\n** Documented cardiomyopathy
Cardiac disease that would preclude administration of the drugs included in the study treatment regimen including, but not limited to:\r\n* Angina pectoris that requires the current use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with documented compromise in cardiac function; and symptomatic pericarditis
Patient has active cardiac disease including any of the following: \r\n* Corrected QT (QTc) > 500 msec on screening electrocardiogram (ECG) (using the QTc Fridericia [F] formula)\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with document compromise in cardiac function\r\n* Symptomatic pericarditis
Active cardiac disease: symptomatic angina pectoris within the past 90 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis
Patient has active cardiac disease including any of the following:\r\n* Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\r\n* Corrected QT (QTc) interval > 480 msec on screening electrocardiogram (ECG) (using the QTc Fridericia [F] formula)\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with document compromise in cardiac function\r\n* Symptomatic pericarditis
Patient has active cardiac disease including any of the following:\r\n* Left ventricular ejection fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)\r\n* Corrected QT (QTc) > 480 msec on screening electrocardiogram (ECG) (using the QT with Fridericia’s Correction [QTcF])\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with document compromise in cardiac function\r\n* Symptomatic pericarditis
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:\r\n* Active cardiac disease\r\n** Angina pectoris that requires the current use of anti-anginal medication;\r\n** Ventricular arrhythmias except for benign premature ventricular contractions;\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\r\n** Conduction abnormality requiring a pacemaker;\r\n** Valvular disease with documented compromise in cardiac function; or\r\n** Symptomatic pericarditis\r\n* History of cardiac disease\r\n** Prior myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;\r\n** History of documented congestive heart failure (CHF) defined as symptomatic heart failure with an LVEF < 40%; or\r\n** Documented cardiomyopathy
Participant has active cardiac disease including any of the following:\r\n* Angina pectoris that requires the use of anti-anginal medications\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with document compromise in cardiac function\r\n* Symptomatic pericarditis
Patient has a history of cardiac dysfunction or disease including any of the following:\r\n* Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular ejection fraction (LVEF) function\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV) or documented cardiomyopathy\r\n* Corrected QT (QTc) interval > 470 msec on screening electrocardiogram (EKG) (using the QTc-Fridericia [QTcF] formula)\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medications\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with documented compromise in cardiac function\r\n* Known history of QT/QTc prolongation or torsades de pointes (TdP); patients who are currently receiving treatment with medication with a known risk to prolong the QT interval or inducing torsades de pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drugs\r\n* Symptomatic pericarditis\r\n* ST depression or elevation of >= 1.5 mm in 2 or more leads
Subject has active cardiac disease or a history of cardiac dysfunction including any of the following:\r\n* Unstable angina pectoris within 6 months prior to study entry\r\n* Symptomatic peritonitis\r\n* Documented myocardial infarction within 6 months prior to study entry\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy\r\n* Subject has a left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\r\n* Subject has any of the following cardiac conduction abnormalities\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medicine\r\n* Conduction abnormality requiring a pacemaker\r\n* Other cardiac arrhythmia not controlled with medication
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:\r\n* Active cardiac disease:\r\n** Angina pectoris that requires the use of anti-anginal medication;\r\n** Ventricular arrhythmias except for benign premature ventricular contractions;\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\r\n** Conduction abnormality requiring a pacemaker;\r\n** Valvular disease with documented compromise in cardiac function; and\r\n** Symptomatic pericarditis\r\n*History of cardiac disease:\r\n** Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;\r\n** History of documented congestive heart failure (CHF); and\r\n** Documented cardiomyopathy
Patient has active cardiac disease including any of the following: \r\n* Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) \r\n* Corrected QT (QTc) > 480 msec on screening electrocardiogram (ECG) (using the Fridericia QT correction [QTcF] formula)\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with document compromise in cardiac function \r\n* Symptomatic pericarditis
Patient has active cardiac disease or cardiac dysfunction including any of the following:\r\n* Left ventricular ejection fraction (LVEF) 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\r\n* Corrected QT interval (QTc) > 480 msec on screening electrocardiogram (ECG) (using the QTc Fridericia's [QTcF] formula)\r\n* Angina pectoris that requires the use of anti-anginal medications\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with documented compromise in cardiac function\r\n* Symptomatic pericarditis\r\n* Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall motion abnormalities on assessment of left ventricular ejection fraction function\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy\r\n* Congenital long QT syndrome
Patient has known active cardiac disease including any of the following:\r\n* Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) \r\n* Corrected QT interval (QTc) > 480 msec on screening echocardiogram (ECG) (using the QT interval corrected by the Fridericia formula [QTcF])\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with document compromise in cardiac function \r\n* Symptomatic pericarditis
Patients with active cardiac disease including any of the following:\r\n* Left ventricular ejection fraction < 50% as determined by multi gated acquisition scan (MUGA) scan or echocardiogram\r\n* Corrected QT (QTc) > 480 msec on screening ECG (using the corrected QT interval using the Fridericia's [QTcF] formula)\r\n* Active angina pectoris\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular or nodal arrhythmias or any conduction abnormality requiring a pacemaker or automatic implantable cardioverter defibrillator (AICD)\r\n* Valvular disease with documented compromise in cardiac function\r\n* Symptomatic pericarditis\r\n* Myocardial infarction within the past 6 months\r\n* Congestive heart failure (New York Heart Association [NYHA] functional classification III-IV)
Patient has active cardiac disease including any of the following: \r\n* History of clinically significant heart failure (previously assessed) with a left ventricular ejection fraction (LVEF) of < 50% as determined by multiple grated acquisition (MUGA) scan or echocardiogram (ECHO) \r\n* Corrected QT (QTc) > 480 msec on screening electrocardiogram (ECG) (using the Fridericia QT correction [QTcF] formula)\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with document compromise in cardiac function \r\n* Symptomatic pericarditis
Active cardiac disease including any of the following:\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with documented compromise in cardiac function\r\n* Symptomatic pericarditis
Patient has active cardiac disease including any of the following:\r\n* Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\r\n* QTc > 450 msec on screening electrocardiogram (ECG) (using the QTcF formula)\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with document compromise in cardiac function\r\n* Symptomatic pericarditis
Active cardiac disease including any of the following:\r\n* History of left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\r\n* Frederica corrected QT interval (QTcF) > 450 msec on screening electrocardiogram (ECG)\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* History of ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with documented compromise in cardiac function\r\n* Symptomatic pericarditis
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