The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorder in the opinion of the investigator
Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive bilateral lung disease on high resolution computed tomography scan or any psychiatric disorder that prohibits obtaining informed consent
Patients with uncontrolled hyperglycemia
Patients with uncontrolled hyperlipidemia
No uncontrolled adrenal insufficiency
Current evidence of any of the following:\r\n* Known gastrointestinal disorder affecting absorption of oral medications\r\n* Active uncontrolled infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis) \r\n* Uncontrolled hypertension\r\n* Any current condition that in the opinion of the investigator, would preclude participation in this study
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression, superior vena cava syndrome, symptomatic congestive heart failure, unstable angina pectoris, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent and would limit compliance with study requirements
Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Participants considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, corrected QT interval (QTc) prolongation > 470 msec, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), extensive bilateral lung disease with less than 20% predicted lung function by carbon monoxide diffusing capability test (DLCO) (Lung Diffusion Capacity Testing), or any psychiatric disorder that prohibits obtaining informed consent
Patients with uncontrolled seizures
Any serious uncontrolled medical disorder or active infection that would impair the subject’s ability to receive investigational product, such as conditions associated with frequent diarrhea
Concurrent severe or uncontrolled medical disease (i.e., systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure).
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including arterial thrombosis, or symptomatic pulmonary embolism)
Poor medical risk because of other conditions such as uncontrolled systemic diseases, active uncontrolled infections, or comorbidities that may put the patient at risk of not being able to complete at least 2 cycles of treatment.
Any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections etc.)
Current severe, uncontrolled systemic disease other than cancer
Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by study treatment, such as severe hereditary coagulation disorders or insulin-dependent diabetes mellitus that is not optimally controlled with medical management (example, presence of ketoacidosis)
Uncontrolled tumor-related pain, or uncontrolled hypercalcemia or clinically significant (symptomatic) hypercalcemia
Current severe, uncontrolled systemic disease
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Patient with any underlying medical condition that the treating physician considers might be aggravated by treatment or which is not controlled (e.g. elevated troponin or creatinine, uncontrolled diabetes)
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\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* Psychiatric illness/social situations that would limit compliance with study requirement
Uncontrolled angina - Canadian Cardiovascular Society grade II-IV despite medical therapy
Participants who have any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases or other disease with ongoing fibrosis
Patients with uncontrolled seizures
Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results\r\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, superior vena cava syndrome, extensive bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
Uncontrolled thyroid disease or cystic fibrosis.
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the study or compromise compliance with the protocol (e.g. chronic pancreatitis, active untreated or uncontrolled fungal, bacterial, or viral infections, etc.)
Uncontrolled electrolyte disorders.
Has a serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled psychiatric condition, uncontrolled intercurrent illness including active infection, arterial thrombosis, or symptomatic pulmonary embolism).
Uncontrolled intercurrent illness judged by the treating investigator to preclude treatment with chemotherapy
Evidence of severe or uncontrolled systemic diseases
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Participants will be excluded for medical conditions that are contraindications to XRT and/or might confound the relationship among fatigue, and inflammation, including pregnancy, unstable major psychiatric disorders, autoimmune (active within the past 6 months) or inflammatory disorders, chronic infectious diseases (e.g. human immunodeficiency virus [HIV], hepatitis B or C), neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history, physical examination or laboratory testing) unless otherwise approved by the PI or PI’s designee
No serious medical conditions such as myocardial infarction within 6 months prior to entry, congestive heart failure, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled psychotic disorders, serious infections, active peptic ulcer disease, psychiatric illness, or any other medical conditions that might be aggravated by treatment or limit compliance
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration)
History of psychiatric drug abuse that cannot be ended, or subjects with mental disorders that will prevent compliance or evaluation including uncontrolled schizophrenia, uncontrolled depression or other uncontrolled disorders.
Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
Presence of any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
Have evidence of uncontrolled disseminated intravascular coagulation
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Current evidence of any of the following:\r\n* Uncontrolled hypertension despite addition or adjustment of antihypertensive regimen\r\n* Gastrointestinal disorder affecting absorption\r\n* Active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Patients with uncontrolled inter-current illness are excluded
Patients with uncontrolled seizures are not eligible for the study
Uncontrolled chronic diarrhea > grade 2 at baseline.
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the trial OR which would jeopardize compliance with the protocol such as active infection (e.g., hepatitis B, hepatitis C or human immunodeficiency virus [HIV]). Screening for chronic conditions is not required.
At high medical risk because of non-malignant systemic disease including uncontrolled infection
Patients must have no serious or uncontrolled medical conditions
Serious clinically significant illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, uncontrolled hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, symptomatic autoimmune diseases (such as inflammatory bowel disease, autoimmune hepatitis, uncontrolled hypo or hyperthyroidism), severe obstructive or restrictive pulmonary diseases, retinopathy, active systemic infections, and inflammatory bowel disorders
Subjects with uncontrolled seizures
Evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding diatheses, or active infection.
Severe or uncontrolled medical disorder that would, in the investigator’s opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, fever, systemic and/or uncontrolled infections, psychiatric illness/social situations that would limit compliance with study requirements)
Uncontrolled infection or other serious medical illnesses.
Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
Uncontrolled concomitant disease
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Severe or uncontrolled medical disorder that would, in the investigator’s opinion, confound study analyses of treatment response (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements)
Heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, ongoing cardiac arrhythmia requiring medication (Grade ?2, by NCI CTCAE v. 4.03), or significant/unstable concurrent medical illness by investigator opinion
Any significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the medical risks of participating in this study (i.e., uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe chronic pulmonary disease or active uncontrolled infection, uncontrolled or clinically relevant pulmonary edema).
Uncontrolled fecal incontinence
Other significant or uncontrolled medical illness; patients with a remote history of asthma or active mild asthma may participate
Patients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician (upper respiratory tract viral infection does not constitute an uncontrolled infection in this context)
Uncontrolled inter-current illness
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: \r\n* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n** History or presence of serious uncontrolled ventricular arrhythmias\r\n** Clinically significant resting bradycardia\r\n** Left ventricular ejection fraction (LVEF) assessed by 2-dimensional (2-D) echocardiogram (ECHO) < 50% or lower limit of normal (whichever is higher) or multiple gated acquisition scan (MUGA), < 45% or lower limit of normal (whichever is higher)\r\n** Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA), pulmonary embolism (PE)\r\n** Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication(s)\r\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) \r\n* Cirrhosis, chronic active hepatitis or chronic persistent hepatitis \r\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)\r\n* Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin; full-dose anti-coagulation with low molecular weight heparin is permitted\r\n* Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
Evidence of uncontrolled extrathoracic metastases
TREATMENT WITH SJCAR19: Evidence of active, uncontrolled neurologic disease
Subjects with evidence of severe or uncontrolled systemic disease, or any concurrent condition, which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies (human immunodeficiency virus [HIV]-positive subjects on combination antiretroviral therapy are eligible), hepatitis B, hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 3 months, uncontrolled cardiac arrhythmia, stroke/cerebrovascular accident within the past 3 months, or psychiatric illness/social situations which would jeopardize compliance with the protocol
Subjects with a known history of uncontrolled seizures
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the study or compromise compliance with the protocol (e.g. chronic pancreatitis, active untreated or uncontrolled fungal, bacterial, or viral infections, etc.)
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Any medical conditions that, in the investigator’s opinion, would impose excessive risk to the subject, e.g., any uncontrolled disease, such as pulmonary disease, infection, seizure disorder, uncontrolled hyperglycemia
Subjects with uncontrolled seizures.
Other concurrent severe and/or uncontrolled medical conditions
Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan, history of pneumonitis, or any psychiatric disorder that prohibits obtaining informed consent.
Significant concurrent, uncontrolled medical condition
Uncontrolled hematuria
Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required
Active and uncontrolled comorbidities including active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, clinically significant and uncontrolled arrhythmia as judged by the treating physician
History of uncontrolled seizures within 6 months of randomization
Patients with uncontrolled seizures
Contraindications to the use of beta-blockers, like, uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (grade III or IV), hypotension (systolic blood pressure < 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (glycosylated hemoglobin [HbA1C] > 8.5 or fasting plasma glucose > 160 mg/dl at screening), symptomatic peripheral arterial disease or Raynaud’s syndrome, untreated pheochromocytoma, current use or past use in the last two years of beta-blockers or calcium channel blockers
Uncontrolled tumour-related pain
Uncontrolled or symptomatic hypercalcemia
The patient has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
Unstable medical comorbidities (i.e. uncontrolled cardiac comorbidities)
Uncontrolled hydropericardium
Concurrent severe and/or uncontrolled medical conditions, which may compromise participation in the study, including impaired heart function or clinically significant heart disease
Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment
Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.
Ineligible for immune checkpoint inhibitors based on package insert of the chosen immune checkpoint inhibitor (e.g., uncontrolled immunologic disorders, active hepatitis, active colitis, active pneumonitis, uncontrolled/active hormone gland problems - including thyroid, pituitary, adrenal glands and pancreas)
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
A serious uncontrolled medical disorder or active infection, which would impair the ability of the subject to receive protocol therapy
Uncontrolled disease-related metabolic disorder (e.g., hypercalcemia);
Subjects with uncontrolled seizures
Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, superior vena cava syndrome, extensive bilateral lung disease on high-resolution computed tomography scan, uncontrolled seizures or any psychiatric disorder that prohibits obtaining informed consent.
Severe, uncontrolled systemic disease at screening;
Subjects with uncontrolled seizures
A serious uncontrolled medical condition requiring therapy
Subjects with uncontrolled seizures
Uncontrolled concomitant disease
Subjects with uncontrolled seizures
Life-threatening visceral disease or other severe concurrent disease that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures.
Patients should not have a history of uncontrolled seizures
A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment
Unstable or severe uncontrolled medical condition (e.g. unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator’s judgment, increase the risk to the patient associated with his or her participation in the study
Uncontrolled hyper- or hypothyroidism
Serious concomitant systemic disorders (e.g., active uncontrolled infection or uncontrolled diabetes) or psychiatric disorders that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction =< 6 months prior to study entry
Other concurrent severe and/or uncontrolled medical conditions including need for urgent dentoalveolar surgery as indicated by preventative dental exam
Severe or uncontrolled medical disorder that would, in the investigator’s opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements
Uncontrolled hypercalcemia
Uncontrolled concomitant disease
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Uncontrolled intercurrent illness including, but not limited to: \r\n* Ongoing or active infections\r\n* Cardiac conditions, such as:\r\n** Symptomatic congestive heart failure\r\n** Uncontrolled hypertension\r\n** Unstable angina pectoris\r\n** Cardiac arrhythmia\r\n* Active peptic ulcer disease or gastritis\r\n* History of inflammatory bowel disease, ulcerative colitis or Crohn’s disease\r\n* Active bleeding diatheses\r\n* Any subject known to have evidence of acute or chronic hepatitis B or hepatitis C. Patients will undetectable levels of virus will be allowed to participate\r\n* Any subject known to have evidence of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)\r\n* Uncontrolled seizures
Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the investigator (e.g., uncontrolled congestive heart failure, active infection, etc.);
Absolute contraindications to cardiopulmonary exercise testing and/or aerobic training, as\r\ndetermined by the attending oncologist:\r\n* Absolute contraindications\r\n** Uncontrolled arrhythmia causing symptoms or hemodynamic compromise\r\n** Recurrent syncope\r\n** Active endocarditis\r\n** Acute myocarditis or pericarditis\r\n** Symptomatic severe aortic stenosis\r\n** Uncontrolled heart failure\r\n** Suspected dissecting aneurysm\r\n** Uncontrolled asthma\r\n** Pulmonary edema\r\n** Room air desaturation at rest =< 85%\r\n** Respiratory failure\r\n** Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)\r\n** Mental impairment leading to inability to cooperate
A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment
Current evidence of active and uncontrolled infection, NYHA Class III-IV CHF, documented Child's class B and C cirrhosis, active pancreatitis or uncontrolled medical disease which in the opinion of the investigator could compromise assessment of efficacy.
Uncontrolled adrenal insufficiency
Any concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate subject participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
Subjects with uncontrolled seizures
Uncontrolled adrenal insufficiency
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac [including life threatening arrhythmias])
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks and contraindicate patient’s participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, severe, uncontrolled hypertension (systolic >150/diastolic > 100 mmHg) or other symptoms of catecholamine excess after efforts to achieve adequate alpha blockade then beta blockade
No contraindications to the study medications or uncontrolled medical illness
Subjects with uncontrolled seizures.
Uncontrolled seizures
Concurrent severe and/or uncontrolled medical condition or psychiatric condition
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
Uncontrolled cancer pain
Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal [GI] tract ulceration)
Uncontrolled adrenal insufficiency
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated or unstable within at least 28 days prior to registration), superior vena cava syndrome, extensive bilateral lung disease on high-resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
The presence of any other concurrent severe and/or uncontrolled medical condition that would, in the investigator or treating physician’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol; this includes uncontrolled infections that could potentially be exacerbated by anti-neoplastic treatment, active untreated or uncontrolled fungal bacterial or viral infections, etc
Subjects with uncontrolled seizures
Uncontrolled intercurrent medical condition including, but not limited to:\r\n* Uncontrolled infection\r\n* Symptomatic congestive heart failure (New York Heart Association [NYHA] class III-IV)\r\n* Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening\r\n* Uncontrolled cardiac arrhythmia or arrhythmia requiring medication other than beta blocker\r\n* Psychiatric illness/social situations that would limit compliance with study requirements\r\n* Any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, etc.)
Subjects with uncontrolled seizures
Severe or uncontrolled concurrent disease, infection or comorbidity.
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise adherence to the protocol (e.g. uncontrolled diabetes, uncontrolled infection, etc.)
Active and uncontrolled disease/(active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association [NYHA] class III/IV, clinically significant and uncontrolled arrhythmia) as judged by the treating physician
Subjects with uncontrolled seizures
Current severe or uncontrolled systemic disease
Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
Subjects with uncontrolled seizures
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Uncontrolled dysrhythmias or poorly controlled angina.
Subjects with uncontrolled seizures
Active and uncontrolled disease/infection as judged by the treating physician, sources for the determination of clinical significance by the treating physician will be included in the subject’s medical record
The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
Major medical conditions that might affect study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled serious infection, cardiac disease)
Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:\r\n* Clinically significant cardiac diseases, including any of the following:\r\n** History or presence of serious uncontrolled ventricular arrhythmias \r\n** Clinically significant resting bradycardia\r\n** Any of the following within 3 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA), pulmonary embolism (PE)\r\n** Uncontrolled hypertension defined by a systolic blood pressure (SBP) ? 160 mmHg and/or diastolic blood pressure (DBP) ? 100 mm Hg, with or without anti-hypertensive medication(s)\r\n* Cirrhosis, chronic active hepatitis or chronic persistent hepatitis\r\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)\r\n* Known diagnosis of any condition (i.e. post-hematopoietic or organ transplant, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc.) that requires chronic immunosuppressive therapy; usage of non-steroidal anti-inflammatory medications (NSAIDS) for the treatment of osteoarthritis and uric acid synthesis inhibitors for the treatment of gout are permitted; for questions, please consult the study chair\r\n* Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined
Patients with active, uncontrolled psychiatric disorders including: psychosis, major depressive, and bipolar disorders
PART 1 EXCLUSION CRITERIA: Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., chronic medical or psychiatric condition or laboratory abnormality, uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection (including hepatitis A, B or C, human immunodeficiency virus [HIV] [testing is not mandatory])
PART 2 GROUP 1 EXCLUSION CRITERIA: Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., chronic medical or psychiatric condition or laboratory abnormality, uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection (including hepatitis A, B or C, human immunodeficiency virus [HIV] [testing is not mandatory])
PART 2 GROUP 2A EXCLUSION CRITERIA: Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., chronic medical or psychiatric condition or laboratory abnormality, uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection (including hepatitis A, B or C, human immunodeficiency virus [HIV] [testing is not mandatory])
PART 2 GROUP 3 EXCLUSION CRITERIA: Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., chronic medical or psychiatric condition or laboratory abnormality, uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection (including hepatitis A, B or C, human immunodeficiency virus [HIV] [testing is not mandatory])
Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol; screening for chronic conditions is not required
Patients being considered at poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease.
Uncontrolled peripheral edema (2+ or more) of any etiology
Subjects with uncontrolled seizures
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Subjects with uncontrolled seizures
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, renal failure, cardiac arrhythmia, interstitial lung disease, hepatic failure / hepatorenal syndrome, gastrointestinal (GI) perforation, cerebrovascular event, microangiopathic hemolytic anemia, corneal perforation/ulceration, or documented hepatitis B virus infection
Symptomatic or uncontrolled arrhythmias
Evidence of severe or uncontrolled systemic diseases:
known uncontrolled arrhythmias (except sinus arrhythmia) in the past 24 weeks.
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Uncontrolled dysrhythmias or poorly controlled angina.
Any uncontrolled active medical disorder that would preclude participation as outlined
Patients with any other severe and/or uncontrolled concurrent disease affecting the cardiovascular system, liver, kidneys, hematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures/results or compromise compliance with the protocol.
Any uncontrolled active medical disorder that would preclude participation
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Subjects with uncontrolled seizures
Not deemed a candidate for concurrent CRT for medical reasons, such as uncontrolled infection (including human immunodeficiency virus [HIV]), or uncontrolled diabetes mellitus which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
Any uncontrolled medical or psychiatric disorder that would preclude participation
Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Uncontrolled intercurrent illness, condition, or circumstances that could limit compliance with the study, including, but not limited to the following: acute or chronic graft versus host disease, uncontrolled diabetes mellitus or hypertension, or psychiatric conditions
Major medical conditions that might affect study participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) are not eligible; other significant comorbid condition which the investigator feels might compromise effective and safe participation in the study
A serious uncontrolled medical disorder or active infection that in the investigator’s opinion would impair the patient’s ability to receive study treatment
Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy.
Active, uncontrolled infection, any other concurrent disease, or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
Subjects with evidence of severe or uncontrolled systemic disease, or any concurrent condition, which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies, hepatitis B, hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, stroke/cerebrovascular accident within the past 6 months, or psychiatric illness/social situations which would jeopardize compliance with the protocol
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on high resolution CT scan or any psychiatric disorder that prohibits obtaining informed consent
Uncontrolled medical illnesses
Subject has uncontrolled thyroid dysfunction
Patients with uncontrolled diseases other than cancer will be excluded
Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form
Severe or uncontrolled medical disorder that would, in the investigator’s opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements)
Uncontrolled hypercalcemia
Uncontrolled concomitant disease
Active and uncontrolled disease/(active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association [NYHA] class III/IV, clinically significant and uncontrolled arrhythmia) as judged by the treating physician
Current severe, uncontrolled systemic disease
Has any other severe, uncontrolled medical condition, including uncontrolled DM or unstable CHF
Patients with untreated or uncontrolled neuropsychiatric illness
Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, coronary artery disease, congestive heart failure) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study
Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results including uncontrolled severe infections, as well as uncontrolled cardiac disease, or other organ dysfunction; patients with history of tuberculosis, human immunodeficiency virus (HIV) or hepatitis B and C are excluded
Uncontrolled arrhythmias
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy
Serious concomitant illness including but not limited to: uncontrolled cardiac arrhythmias, unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled arterial hypertension, uncontrolled diabetes mellitus, dementia, active infection (including human immunodeficiency virus [HIV] infection) requiring IV or oral antibiotics and psychiatric illness
Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, chronic renal disease, chronic pulmonary disease or active uncontrolled infection)
No clinical evidence of uncontrolled active infectious process
No clinical evidence of uncontrolled active infectious process
Infectious diseases: no clinical evidence of uncontrolled active infectious process
Infectious diseases criteria: no clinical evidence of uncontrolled active infectious process
Any concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities
Any ophthalmopathy visible at screening that would be considered a risk factor for CSR or RVO by the ophthalmologist (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled diabetes mellitus, history of hyperviscosity or hypercoagulability syndromes)
Other co-morbidity, which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated lung disease
Patients with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the patient to cooperate and participate in the trial; other examples of such conditions would include COPD or diabetes mellitus that has required 2 or more hospitalizations in the last year; severe peripheral vascular disease; poorly controlled auto-immune conditions; recent serious trauma.
Other serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy
Any uncontrolled active medical disorder that would preclude participation as outlined
Uncontrolled medical or psychiatric disorders
Patients have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
Patients with any other known disease concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, cardiovascular disease including congestive heart failure, myocardial infarction within 6 months and poorly controlled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study. Patients with current active malignancies or any remission for < 6 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may have active disease or be in remission for less than 6 months.
Relapsed/refractory MCL: Any serious medical condition that places the patient at unacceptable risk and/or would prevent the subject from signing the informed consent form; examples include but are not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, active infection, active hemorrhage, or psychiatric illness
Newly Diagnosed MCL: Any serious medical condition that places the patient at unacceptable risk and/or would prevent the subject from signing the informed consent form; examples include but are not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, active infection requiring treatment with systemic antibiotics, antiviral or antifungal agents, active hemorrhage, or psychiatric illness
Other concurrent severe and/or uncontrolled medical conditions
Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy; this includes uncontrolled hypertension and uncontrolled diabetes, as cases of life threatening hyperglycemia have been reported (using continuous infusion at higher doses of omacetaxine)
Any other serious uncontrolled medical disorder or active infection that would impair the patient’s ability to receive study treatment (at the discretion of the investigator)
Any ophthalmopathy visible at screening that would be considered a risk factor for CSR or RVO by the ophthalmologist (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled diabetes mellitus, history of hyperviscosity or hypercoagulability syndromes)
Any evidence, as judged by the investigator, of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Patients must be free of other active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy
No uncontrolled thyroid disease (e.g. hyperthyroid/hypothyroidism)
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support
Severe/uncontrolled concurrent illness/infection
Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support
Serious uncontrolled medical disorder or uncontrolled active systemic infection or current unstable or decompensated respiratory or cardiac conditions which makes it undesirable or unsafe for the patient to participate in the study
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Have evidence of uncontrolled disseminated intravascular coagulation
uncontrolled comorbid conditions
Any serious uncontrolled medical disorder that would impair the ability of the subject to receive protocol-driven therapy
Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases; at the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled
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
Uncontrolled medical problems
Uncontrolled medical problems
No other serious concomitant medical illnesses or uncontrolled active infection that would jeopardize the patient's ability to receive the regimen with reasonable safety
Uncontrolled pain that results in patient's lack of compliance with the imaging procedures
Any evidence of severe or uncontrolled systemic or psychiatric diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Current serious illness or medical conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders.
Any evidence of severe or uncontrolled systemic diseases
Severe or uncontrolled systemic diseases including uncontrolled hypertension, active bleeding diatheses
Have any serious or unstable concomitant systemic conditions that are incompatible with this clinical study, including but not limited to substance abuse, psychiatric disturbance, or uncontrolled intercurrent illness (including active infection), arterial thrombosis, or symptomatic pulmonary embolism
Patients who have any severe and/or uncontrolled medical conditions
Has significant renal or hepatic disease, uncontrolled or severe cardiovascular or pulmonary diseases, or other uncontrolled medical condition that, based on the Investigator's assessment, would compromise the patient's ability to tolerate study treatment or the assessment of treatment response.
Severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (? Grade 2, according to NCI CTCAE v4.0) or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
Uncontrolled diarrhea
Uncontrolled nausea or vomiting
Concurrent severe or uncontrolled medical disease.
Concurrent severe or uncontrolled medical disease.
Serious concomitant medical illness, such as active infection, uncontrolled congestive heart failure, or uncontrolled diabetes or other metabolic disorder, or psychiatric illness;
Untreated, uncontrolled Sleep apnea
Other significant or uncontrolled medical illness; patients with a remote history of asthma or active mild asthma may participate
Subjects with uncontrolled medical or mental illness that, in the Investigator's judgement, could affect treatment tolerability or compliance.
Uncontrolled adrenal insufficiency.
Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, uncontrolled diabetes, serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct, or psychiatric illness/social situations.
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.  Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 5 years) myocardial infarction, uncontrolled major seizure disorder, uncontrolled hypertension (blood pressure [BP] ? 160/100), stroke within the past 5 years, uncontrolled diabetes (hemoglobin [hgb] A1C >7), unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
Patients with uncontrolled seizures.
Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
Symptoms of uncontrolled intracranial pressure
Serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment.
Unmanaged/uncontrolled mental health disorder
Uncontrolled, severe concomitant comorbidity (e.g. uncontrolled hypertension, uncontrolled diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Patients with uncontrolled seizures.
Subjects with uncontrolled seizures
Any uncontrolled concurrent illness that, in the judgment of the investigators or treating physician, may put the patient at undo risk including but not limited to active infection, symptomatic cardiac or pulmonary disease, ventricular arrhythmia, or psychiatric illness
Uncontrolled non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
Any serious medical condition that places the patient at unacceptable risk and/or would prevent the subject from signing the informed consent form. Examples include but are not limited to uncontrolled hypertension, uncontrolled diabetes mellitus, active /symptomatic coronary artery disease, active infection, active hemorrhage, and psychiatric illness.
Any severe or uncontrolled medical condition or other condition that could affect participation in this study, including: unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction =< 6 months prior to study entry
Any severe or uncontrolled medical condition or other condition that could affect participation in this study, including but not limited to: unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, uncontrolled hypertension, or myocardial infarction ? 6 months prior to study entry
History of uncontrolled seizures; (Note: patients are eligible for the study if the seizures are well controlled with standard medications)
Uncontrolled cancer pain
Uncontrolled serious chronic gastrointestinal condition associated with diarrhea
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent and would limit compliance with study requirements
Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
Subjects with uncontrolled seizures
Any severe and/or uncontrolled medical conditions or other conditions that, in the treating physician's opinion, could adversely impact their ability to participate in the study
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as any active (acute or chronic) or uncontrolled infection/ disorders or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator’s judgment, contraindicate patient participation in the clinical study (eg. active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Uncontrolled hypercalcemia
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial, or viral infections etc.)
Uncontrolled psychiatric condition
No serious uncontrolled coexisting medical condition
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Patients must not have any severe and/or uncontrolled medical condition or other\n             conditions that could affect their participation in the study, including, but not\n             restricted to:
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent; evidence of severe or uncontrolled systemic disease or any concurrent condition which, in the investigator's opinion, makes it desirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
Patients with uncontrolled seizures
Uncontrolled intercurrent illness considered by the investigator to constitute an unwarranted high risk for investigational drug treatment; examples include, but not limited to the following: \r\n* Uncontrolled serious infection; or \r\n* Unstable angina pectoris; or \r\n* Uncontrolled cardiac arrhythmia; or\r\n* Active second malignancy requiring treatment; or\r\n* Symptomatic congestive heart failure
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Patients with any other known active cancer (except carcinoma in-situ), concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, pulmonary, chronic renal disease, active uncontrolled infection)
Uncontrolled hypercalcemia
Concomitant severe or uncontrolled medical disease
Uncontrolled co-morbidities
Subjects with a known unstable or uncontrolled angina pectoris.
Subjects with known unstable or uncontrolled angina pectoris.
Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment
Serious concurrent uncontrolled medical disorder
Patients with known unstable or uncontrolled angina pectoris
Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
As judged by the Investigator, any evidence of severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension, history of, or active, bleeding diatheses (eg, hemophilia or von Willebrand disease) or uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug.
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or contraindicate the use of an investigational drug, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases
Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes
Concurrent severe and/or uncontrolled medical conditions which may compromise participation in the study, including impaired heart function or clinically significant heart disease
As judged by the Investigator, any evidence of severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension, history of, or active, bleeding diatheses (eg, hemophilia or von Willebrand disease) or uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug.
Subjects with uncontrolled and significant inter-current illness.
Acute and chronic, active infectious disorders and non malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
Has any of the following medical conditions: uncontrolled diabetes, psychiatric disorder (including dementia) that prevents compliance with protocol, uncontrolled seizures, newly diagnosed deep vein thrombosis, active systemic infection that is likely to interfere with study procedure or results
Current severe, uncontrolled systemic disease
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
Severe or uncontrolled concurrent disease, infection or co-morbidity.
Patients must have no non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with protocol therapy
Patients with uncontrolled seizures
Concurrent severe and/or uncontrolled medical conditions (uncontrolled diabetes or infection), known infection with HIV, Hepatitis B or Hepatitis C.
Life expectancy severely limited by concomitant illness or uncontrolled infection
Evidence of any significant, uncontrolled concomitant disease
Severe or uncontrolled medical conditions
Uncontrolled heart disease
Have uncontrolled chronic atrial fibrillation.
Uncontrolled chronic diarrhea ? grade 2 at baseline.
No history of uncontrolled seizures
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)
Other concurrent severe and/or uncontrolled concomitant medical conditions (eg, active or uncontrolled infection or renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol.
Uncontrolled or symptomatic hypercalcemia
Participant has any of the following conditions: Non-secretory or oligo-secretory multiple myeloma, active plasma cell leukemia i.e., either 20% of peripheral white blood cells or greater than 2.0 X 10^9/liter (L) circulating plasma cells by standard differential, waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), known Human Immunodeficiency Viral (HIV) infection, active hepatitis B or C infection based on blood screen tests, significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of randomization, or congestive heart failure New York Heart Association (NYHA) Class greater than or equal to 3, Major surgery within 4 weeks prior to randomization, acute infections requiring parenteral therapy (antibiotic, antifungal, or antiviral) within 14 days prior to randomization, peripheral neuropathy greater than or equal to Grade 3 or greater than or equal to Grade 2 with pain within 2 weeks prior to randomization, uncontrolled diabetes or uncontrolled hypertension within 14 days prior to randomization, any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study
have a serious illness or medical condition including, but not limited to, the following: active or uncontrolled clinically serious infection; inadequate biliary drainage with evidence of unresolved biliary obstruction
have a serious illness or medical condition including, but not limited to, the following: active or uncontrolled clinically serious infection, including chronic viral hepatitis
Serious uncontrolled medical disorder
Any concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities
Active and uncontrolled disease/(active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association [NYHA] class III/IV, clinically significant and uncontrolled arrhythmia) as judged by the treating physician
Uncontrolled concurrent disease or illness
Any uncontrolled active medical disorder that would preclude participation
Any uncontrolled active medical disorder that would preclude participation as outlined
Severe and/or uncontrolled medical disease, including: \r\n* Uncontrolled diabetes mellitus (hemoglobin A1c [A1c] > 8) \r\n* Chronic kidney disease stage III or higher (creatinine clearance < 60 mL/min/m^2 by Modified Diet in Renal Disease [MDRD] calculation) \r\n* Active, uncontrolled infection
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses
Patients with any other known disease (except carcinoma in-situ) or concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, cardiovascular disease including congestive heart failure, myocardial infarction within 6 months and uncontrolled hypertension, chronic renal disease [creatinine clearance < 20 ml/min using the Cockcroft and Gault formula], or active uncontrolled infection) which could compromise participation in the study
Uncontrolled thyroid dysfunction
Uncontrolled thromboembolic or hemorrhagic disorders.
Severe or uncontrolled medical disease, including uncontrolled diabetes, congestive heart failure, chronic renal disease or chronic pulmonary disease
Evidence of significant, uncontrolled concomitant disease
Uncontrolled inter-current illness, per protocol.
Uncontrolled undercurrent illness that in the opinion of the treating physician would contraindicate the use of the drug
Any other concurrent severe known disease (except carcinoma in-situ) or concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, or active uncontrolled infection) which could compromise participation in the study
Major or uncontrolled comorbid conditions as determined by the treating physician:\r\n* History of ventricular arrhythmias requiring drug or device therapy\r\n* Uncontrolled angina or symptomatic congestive heart failure\r\n* Severe or uncontrolled infection requiring systemic antibiotic or antifungal therapy or active hepatitis C infection\r\n* Severe or uncontrolled psychiatric illness
Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support. Treatment of pre-existing invasive fungal infections must be completed prior to starting treatment.
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Subject has an ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, active bleeding or any other serious uncontrolled medical disorder
Severe or uncontrolled medical conditions (i.e., uncontrolled diabetes, active or uncontrolled infection)
Concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the investigator, such as but not limited to:\r\n* Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease, or a QTCB (corrected according to Bazett's formula) interval > 470 msec; serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA; uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)\r\n* Acute and chronic active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy\r\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
Patient has any other concurrent severe and/or uncontrolled medical conditions that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.); hepatitis testing at screening is not mandatory, but may be done per investigator discretion
Patients have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, may cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
Other concurrent severe and/or uncontrolled medical disease, psychiatric illness, or social situation, which could compromise safety of treatment as so judged by the treating physician; Note: this includes but is not limited to: severely impaired lung function, uncontrolled diabetes (history of consistent blood glucose readings above 300 mg/dL or less than 50 mg/dL), severe\r\ninfection, severe malnutrition, ventricular arrhythmias, known active vasculitis of any cause, tumor invasion of any major blood vessel, chronic liver or renal disease, and active upper GI tract ulceration
Uncontrolled systemic disease including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B or hepatitis C
Subjects with uncontrolled seizures
Patients with concomitant medical illness such as serious uncontrolled infection, or uncontrolled angina, which in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patient
Has uncontrolled disease-related metabolic disorder
Any serious uncontrolled medical disorder or active infection that would impair the subject’s ability to receive investigational product, such as conditions associated with frequent diarrhea
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, active peptic ulcer disease or gastritis, and active bleeding diatheses
Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical study (eg, chronic pancreatitis, etc.).
Has a history of autoimmune disorders, including uncontrolled diabetes (\uncontrolled\ defined as Hemoglobin A1c ? 9% in 28 days prior to study).
Severe/uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, bleeding diatheses or infection
Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illness
Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk or would prevent the subject from signing the informed consent form
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, contraindicate patient participation in the clinical study (e.g. chronic pancreatitis, chronic active hepatitis, etc.)
Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., uncontrolled diabetes mellitus defined by a glucose greater than 1.5 ULN in spite of adequate medical treatment, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection
Uncontrolled intercurrent illness or serious medical conditions including, but not limited to:\r\n* Clinically significant, uncontrolled, major cardiac, respiratory, renal, hepatic, gastrointestinal, or hematologic disease\r\n* Active uncontrolled infection\r\n* Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device\r\n* No myocardial infarction within 3 months of registration\r\n* Symptomatic inflammatory bowel disease with uncontrolled diarrhea
Malabsorption or uncontrolled peptic ulcer disease
Any other severe, uncontrolled medical condition, including uncontrolled diabetes mellitus or unstable congestive heart failure.
Uncontrolled angina within 3 months before C1D1.
Patients with persistent and uncontrolled atrial fibrillation
Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form
Uncontrolled infection or significant co-morbidity (e.g., uncontrolled diabetes, severe diarrhea that requires total parenteral nutrition [TPN])
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection; uncontrolled hypertension) that could cause unacceptable safety risks or compromise compliance with the protocol\r\n* Significant symptomatic deterioration of lung function; if clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusion capacity of the lung for carbon monoxide (DLco), oxygen (O2) saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates
Any evidence of severe or uncontrolled diseases
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease], uncontrolled chronic renal diseases [glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension (blood pressure >= 140/90), active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus; screening for chronic conditions is not required
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection, New York Heart Association class III or IV congestive heart failure, uncontrolled cardiac arrhythmia) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Severe, uncontrolled systemic disease
Uncontrolled medical disease(s) or active, uncontrolled infection
Active uncontrolled gastric or duodenal ulcer
Uncontrolled inter-current illness, per protocol
Uncontrolled hypothyroidism
Other concurrent severe and/or uncontrolled medical disease, which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal [GI] tract ulceration, congestive heart failure, etc.)
Severe or uncontrolled medical issues
Subjects with known unstable or uncontrolled angina pectoris.
Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled
No clinical evidence of uncontrolled active infectious process
Any uncontrolled thyroid disease
Uncontrolled angina within 6 months
Patients with evidence of uncontrolled current myocardial impairment (e.g. unstable ischemic heart disease, uncontrolled arrhythmia, symptomatic valvular dysfunction not controlled on medical therapy, uncontrolled hypertensive heart disease, and uncontrolled congestive heart failure)
Not deemed a candidate for concurrent chemoradiation for medical reasons, such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV
Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active/uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
Uncontrolled or symptomatic hypercalcemia
Serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control would be jeopardized by protocol therapy
Any concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities
Subjects with known unstable or uncontrolled angina pectoris.
Patients with uncontrolled infections for whom myeloablative hematopoietic stem cell transplant (HCT) is considered contraindicated by the consulting infectious disease physician (upper respiratory tract viral infection does not constitute an uncontrolled infection in this context)
Any other known disease (except carcinoma in-situ), concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, cardiovascular disease including congestive heart failure, myocardial infarction within 6 months and poorly controlled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study; other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretation
Other co-morbidity, which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated lung disease
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease)
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection.
Concurrent severe and/or uncontrolled medical disease including, but not limited to, ongoing or active infection requiring intravenous antibiotics, bowel obstruction
Uncontrolled or severe intercurrent medical condition
Uncontrolled thrombotic or hemorrhagic disorder
Current severe, uncontrolled systemic disease
Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support
Any uncontrolled active medical disorder that would preclude participation as outlined
Concurrent severe and/or uncontrolled medical disease including, but not limited to, ongoing or active infection requiring intravenous antibiotics
Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled congestive heart failure, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), left ventricular ejection fraction (LVEF) less than 40, renal failure, active infection, active hemorrhage, laboratory abnormality, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form; patients with history of cardiac arrhythmias should have cardiac evaluation and clearance
Severe systemic diseases or active uncontrolled illnesses.
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes (defined as HbA1c > 9%), uncontrolled infection)
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Patients with active (uncontrolled, metastatic) second malignancies are excluded.
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Uncontrolled adrenal insufficiency
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection)
Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to: active or uncontrolled infection; or unstable angina pectoris, myocardial infarction within the past 6 months, or uncontrolled cardiac arrhythmia
Patients with evidence of severe or uncontrolled systemic disease, or any concurrent condition, which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies, uncontrolled hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection unless sustained virologic response to HCV therapy, uncontrolled diabetes, serious non-healing ulcer, wound or bone fracture, history of intra-abdominal abscess, abdominal fistula or gastrointestinal perforation within 28 days of treatment, history of pulmonary embolism in the past 12 months, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry, class III or IV heart failure as defined by the NYHA functional classification system, stroke/cerebrovascular accident or transient ischemic attack within the past 12 months or psychiatric illness/social situations which would jeopardize compliance with the protocol
Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction =< 6 months prior to study entry
Severe, concurrent illness including congestive heart failure, significant cardiac disease and uncontrolled hypertension, that would likely prevent the patient from being able to comply with the study protocol
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease)
Evidence of severe or uncontrolled systemic diseases (e.g., unstable, or uncompensated respiratory, hepatic, renal, metabolic or cardiac disease).
Individuals with severe and/or uncontrolled intercurrent illness including, but not limited to:\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n* Unstable angina pectoris, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia or other clinically significant cardiac disease\r\n* Uncontrolled diabetes as defined by fasting serum glucose >= 200 mg/dL (note: participants with history of hyperglycemia receiving medical management whose fasting serum glucose is < 200 mg/dL with that management are eligible for enrollment)\r\n* Psychiatric illness/social situations that would limit compliance with study requirements
Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
No uncontrolled diarrhea
Uncontrolled or unstable medical or psychiatric co-morbidities which would clearly preclude use of MLN8237 or erlotinib
Other concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values that could in the opinion of the investigator cause unacceptable safety risks or compromise compliance with the protocol
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Nonmalignant medical illnesses that are uncontrolled or a controlled illness that may be jeopardized by the treatment with protocol therapy
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
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])
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to, uncontrolled infection, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, stroke/cerebrovascular accident within the past 6 months, or psychiatric illness/social situations that in the investigator’s opinion would make it undesirable for the patient to participate in the trial, or which would jeopardize compliance with the protocol
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
Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, or need for ventilatory support
Any severe and/or uncontrolled medical conditions or other conditions that, in the treating physician’s opinion, could adversely impact their ability to participate in the study; NOTE: patients on chronic oxygen therapy, those with liver disease such as cirrhosis, chronic hepatitis or chronic persistent hepatitis, or uncontrolled infections will be excluded
Current uncontrolled hyperthyroidism
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
Evidence of severe or uncontrolled systemic disease or HIV infection
Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
Severe and uncontrolled disease, including:
g. Untreated and uncontrolled epileptic seizures
Subjects with uncontrolled seizures
Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection;
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
Uncontrolled hyperthyroidism or hypothyroidism
Uncontrolled hyperthyroidism or hypothyroidism
Considered a poor medical risk due to a serious uncontrolled disorder
Patients with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders
Patients with severe and/or uncontrolled medial disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection [persistent fever and worsening clinical condition])
Acute and chronic active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
Subjects known to have an uncontrolled thyroid disorder.
Other concurrent severe and/or uncontrolled medical conditions.
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Active, uncontrolled infection or severe concurrent medical disease, including but not limited to congestive heart failure, cardiac arrhythmias, or psychiatric illness
Uncontrolled disseminated intravascular coagulation.
Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct
Uncontrolled concurrent significant medical or psychological co-morbidity
Subject has severe or uncontrolled systemic diseases including uncontrolled hypertension or active bleeding diatheses.
Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Medical conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, cardiac disease that would, in the opinion of the investigator, make this protocol unreasonably hazardous
Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases).
Patients with congestive heart failure with ejection fraction (EF) < 45% or uncontrolled cardiac disease (such as uncontrolled cardiac arrhythmia, uncontrolled coronary artery disease [CAD] with active symptoms due to CAD defined as unstable angina) are excluded from initiation of study treatment
Uncontrolled symptomatic orthostatic hypotension
Another concurrent illness which would preclude study conduct and assessment, uncontrolled: medical condition, active infection, risk of bleeding, diabetes mellitus, or pulmonary disease, or alcoholic liver disease, or primary biliary cirrhosis.
Subject has severe or uncontrolled systemic diseases or active bleeding diatheses.
Clinically significant medical conditions including active or uncontrolled infections, new or recurrent malignancy, serious cardiac, pulmonary, or renal disease, and uncontrolled diabetes.
Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
Uncontrolled thyroid disease
Patients with any concurrent severe and/or uncontrolled medical condition or active uncontrolled systemic infection as determined by the investigator
Any serious illness or medical condition that would not permit the patient to be managed according to the protocol, including, but not to limited, any the following:\r\n* History of significant neurologic or psychiatric disorder (e.g., uncontrolled psychiatric disorders) that would impair the ability to obtain consent or limit compliance with study requirement\r\n* Active uncontrolled or serious infection\r\n* Active peptic ulcer disease
Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases).
Other concurrent severe and/or uncontrolled concomitant medical conditions (eg, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
Uncontrolled or unstable medical or psychiatric co-morbidities which would clearly limits patients participation
Uncontrolled concomitant medical conditions, including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases.
Uncontrolled diabetes or other medical condition that may interfere with assessment of toxicity.
Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study
Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form
Patients with severe hematologic, neurologic, or other uncontrolled disease
Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible
Symptomatic and/or serious uncontrolled arrhythmia
Any uncontrolled, intercurrent illness that in the opinion of the Investigator may interfere with study evaluation. Participants with uncontrolled diabetes will be excluded from the study.
Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases).
Uncontrolled hypertriglyceridemia (> 450 mg/dL)
Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.
Active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness impairing the ability of the patient to receive protocol treatment.
Patient with any underlying medical condition that the treating physician considers might be aggravated by treatment or which is not controlled (e.g., elevated troponin or creatinine, uncontrolled diabetes)
Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition
Patients with uncontrolled intracranial hypertension syndrome (defined as: persistence of headache, transient visual obscurations, and/or diplopia despite optimal clinical management) or uncontrolled seizure activity (i.e. recorded despite optimal medical management)
As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease], uncontrolled chronic renal diseases [glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension (blood pressure >= 160/90), active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus; screening for chronic conditions is not required
Severe concomitant illness i.e. chronic obstructive pulmonary disease (COPD), ischemic heart disease (IHD), active congestive cardiac failure (CCF), active angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension
Uncontrolled intercurrent illnesses including, but not limited to symptomatic congestive heart failure, severe oxygen dependent chronic obstructive pulmonary disease, unstable angina or uncontrolled cardiac arrhythmia that could jeopardize the subject’s ability to receive the chemotherapy described in the protocol safely
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
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 other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study (e.g., active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.).
Patient has an uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, HIV infection, chronic liver disease. chronic renal disease, pancreatitis, chronic pulmonary disease, active cardiac disease or cardiac dysfunction, interstitial lung disease, active autoimmune disease, uncontrolled diabetes, neuropsychiatric or social situations that would limit compliance with the study requirements.
Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory or cardiac disease)
Current severe, uncontrolled systemic disease
Uncontrolled hypercalcemia
Uncontrolled or severe intercurrent medical condition
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Any evidence of severe or uncontrolled diseases
Active, uncontrolled infection or severe concurrent medical disease, including but not limited to congestive heart failure, cardiac arrhythmias, or psychiatric illness
Severe, concurrent illness including congestive heart failure, significant cardiac disease and uncontrolled hypertension, that would likely prevent the patient from being able to comply with the study protocol
Uncontrolled arrhythmias
Uncontrolled or symptomatic angina
Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac [including life threatening arrhythmias], hepatic, or renal disease)
Presence of serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse; uncontrolled intercurrent illness including active infection; arterial thrombosis; unstable respiratory, hepatic, renal or cardiac disease; and other active malignancy)
Ongoing, significant , uncontrolled medical condition.
Subject has concurrent severe or uncontrolled medical disease or organ system dysfunction which, in the opinion of the Investigators, would limit life expectancy to < 3 months.
Any severe acute or chronic medical condition including uncontrolled diabetes mellitus, severe renal impairment, history of cardiovascular disease (uncontrolled hypertension, arterial thrombotic events in the past 6 months, congestive heart failure, severe or unstable angina pectoris, recent myocardial infraction within last 6 months or uncontrolled cardiac arrhythmia), which could impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.
Any serious, uncontrolled medical disorder that would impair the ability of the subject to receive protocol driven therapy
Known unstable or uncontrolled angina pectoris
As judged by the investigator any evidence of severe or uncontrolled systemic disease
Uncontrolled infection or concomitant medical illness that is not adequately controlled with current medical management, as determined per clinician discretion
High medical risks because of non-malignant systemic disease or with active uncontrolled infection;
Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study
Patients with concurrent severe and/or uncontrolled medical co-morbidities - including active infections, unstable uncontrolled diabetes, cardiovascular and pulmonary, renal, psychiatric or social conditions that could compromise the safety or compliance of treatment are not eligible.
Uncontrolled depression or other major psychiatric disorder
Uncontrolled Hepatitis B despite appropriate therapy.
Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, uncontrolled hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, symptomatic autoimmune diseases, severe obstructive or restrictive pulmonary diseases, uncontrolled endocrine disorders (hypothyroidism, hyperthyroidism and diabetes mellitus), retinopathy, active systemic infections, and inflammatory bowel disorders; this includes known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, or active hepatitis B virus (HBV) and hepatitis C virus (HCV)
Uncontrolled medical illness such as infection requiring intravenous antibiotics
Current severe, uncontrolled systemic disease
Evidence of uncontrolled brain metastases or history of uncontrolled seizures.
Active uncontrolled infectious diseases requiring treatment
Severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (i.e. uncontrolled diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection).
Participants with severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Patients must have no serious or uncontrolled medical conditions
Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:\r\n* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n** History or presence of serious uncontrolled ventricular arrhythmias\r\n** Clinically significant resting bradycardia\r\n** Left ventricular ejection fraction (LVEF) assessed by 2-dimensional (D) echocardiogram (ECHO) =< 50% or lower limit of normal (whichever is higher) or multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (whichever is higher)\r\n** Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA), pulmonary embolism (PE)\r\n** Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication(s)\r\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\r\n* Cirrhosis, chronic active hepatitis or chronic persistent hepatitis\r\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)\r\n* Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin\r\n* Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
Uncontrolled or unstable medical conditions
Patients with uncontrolled malabsorption syndromes
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
Uncontrolled thyroid disease or cystic fibrosis
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal or cardiac disease)
Uncontrolled seizures
Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease, or active, uncontrolled infection.
Poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, uncontrolled hypertension, or any psychiatric disorder that prohibits obtaining informed consent
Poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, uncontrolled hypertension, or any psychiatric disorder that prohibits obtaining informed consent
Uncontrolled hypercalcemia
Concomitant severe or uncontrolled medical disease
Patient has a major medical or co-morbid condition(s) that the investigator believes might compromise safe participation in the study (such as uncontrolled lung, kidney, or liver problems; uncontrolled infection; a history of congestive heart failure; or an electrocardiogram suggesting significant problems with the heart).
Patients who have any severe and/or uncontrolled medical conditions
Other clinically significant co-morbidities such as uncontrolled pulmonary disease, uncontrolled diabetes, active CNS disease, active infection or any other condition that could compromise the patients participation in the study according to the investigator
Concurrent severe uncontrolled illness not related to cancer
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Current severe, uncontrolled systemic disease
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Uncontrolled concurrent illness including: other hematologic or non-hematologic malignancy, active infection, or uncontrolled diabetes
Evidence of severe or uncontrolled systemic disease or any concurrent condition – including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, unstable hypertension, seizure disorder, or psychiatric illness – which in the Investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g. uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection).
Current severe, uncontrolled systemic disease
Concurrent severe or uncontrolled medical disease that would compromise the safety or compromise the ability of the patient to complete the study
Concurrent severe or uncontrolled medical disease that would compromise the safety or compromise the ability of the patient to complete the study
Concurrent severe or uncontrolled medical disease that would compromise the safety or compromise the ability of the patient to complete study
Any other serious uncontrolled medical disorders or psychological conditions
Predisposing factors to retinal vein occlusion including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy.
Uncontrolled current illness
Any serious uncontrolled, medical or psychological disorder that would impair the ability of the patient to receive therapy
In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
Presence of a serious uncontrolled medical disorder.
Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC), hepatic cirrhosis, or chronic kidney disease.
Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
Uncontrolled cystitis, gross hematuria, bladder pain, or bladder spasms, other uncontrolled concurrent illness, or any underlying medical condition, including any underlying conditions resulting in chronic immunosuppression which in the Investigator’s opinion will make the administration of talimogene laherparepvec hazardous, or obscure the interpretation of adverse events
Uncontrolled hypercalcemia
Uncontrolled hypercalcemia
Patients with uncontrolled seizures or any neurological conditions resulting in increased risk for seizures are not eligible for study entry
Any serious medical condition including but not limited to uncontrolled hypertension, uncontrolled diabetes mellitus active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), left ventricular ejection fraction less than 40, active infection, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form; patients with history of cardiac arrhythmias should have cardiac evaluation and clearance
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator’s judgment, contraindicate patient participation in the clinical study (eg. active or uncontrolled severe infection, chronic active hepatitis, immunocompromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)
Current severe, uncontrolled systemic disease
Unstable or severe uncontrolled medical, psychological, or social condition
Patient with serious uncontrolled concurrent medical illness including but not limited to ongoing or active infection, and \currently active\ second malignancies other than non-melanoma skin cancers
Patients must not have uncontrolled asthma
Patient has a severe or uncontrolled medical disorder that would, in the investigator’s opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements)
Contraindications to a 6-minute walk test as recommended by the American Thoracic Society: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) frequent uncontrolled syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) acute deep vein thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) uncontrolled pulmonary edema, (m) new onset room air desaturation at rest =< 85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases; these contraindications are relative and any concern will be clarified with the treating physician with final approval per their judgement
Uncontrolled seizures
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol.
Significant uncontrolled psychiatric or other co-morbid disease, which the primary oncologist believes prohibits the ability to participate in study procedures
Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver surgery
Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician
No absolute contraindications to exercise testing as recommended by the American Thoracic Society; no recent (< 6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection
Uncontrolled pain
Uncontrolled nausea and vomiting
Uncontrolled arrhythmias
Does not have uncontrolled pain
Has uncontrolled pain
Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to:\r\n* Acute myocardial Infarction (within 5 days of any planned study procedure)\r\n* Unstable angina\r\n* Uncontrolled arrhythmia causing symptoms or hemodynamic compromise\r\n* Recurrent syncope\r\n* Active endocarditis\r\n* Acute myocarditis or pericarditis\r\n* Symptomatic severe aortic stenosis\r\n* Uncontrolled heart failure\r\n* Acute (within 3 months) pulmonary embolus or pulmonary infarction\r\n* Thrombosis of lower extremities\r\n* Suspected dissecting aneurysm\r\n* Uncontrolled asthma\r\n* Pulmonary edema\r\n* Room air desaturation at rest =< 85%\r\n* Respiratory failure\r\n* Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis)\r\n* Mental impairment leading to inability to cooperate
Uncontrolled arrhythmias causing symptoms or hemodynamic compromise in the last week
Uncontrolled heart failure in the last week
Uncontrolled medical or psychiatric disorders
Uncontrolled concurrent medical conditions that would limit compliance with study requirements
Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of self-care of LEF: recurrent or metastatic cancer; any other active cancer; acute infection; congestive heart failure; renal failure; cardiac or pulmonary edema; sensitive carotid sinus; severe carotid blockage; and uncontrolled hypertension
Other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled human immunodeficiency virus [HIV], hepatitis B or C), or any psychiatric disorder that prohibits obtaining informed consent
For participants who are randomized in aim 1:\r\n* No uncontrolled serious medical or psychiatric condition(s) that would affect the patient’s ability to participate in the interventional study, e.g., uncontrolled hypertension, symptomatic cardiac disease, or severe/uncontrolled depression as indicated by a Patient Health Questionnaire (PHQ-9) score > 9 (Kroenke)\r\n* No diagnoses of any other invasive malignancy other than endometrial cancer or non-melanoma skin cancer which required active treatment currently
History of any of the following contraindications to oxybutynin:\r\n* Uncontrolled gastroesophageal reflux disease (GERD) despite appropriate therapy; if patient has history of GERD, but symptoms are well-controlled with medical treatment, patient is eligible\r\n* Ulcerative colitis\r\n* Narrow-angle glaucoma\r\n* Urinary retention\r\n* Hypersensitivity to oxybutynin or any other components of the product\r\n* Current uncontrolled hyperthyroidism\r\n* Coronary heart disease (angina or prior myocardial infarction)\r\n* Congestive heart failure\r\n* Symptomatic cardiac arrhythmias\r\n* Current uncontrolled hypertension\r\n* Myasthenia gravis\r\n* Dementia
Other uncontrolled significant illness.
Patients with any evidence of severe or uncontrolled systemic disease (e.g. severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease], uncontrolled chronic renal disease [glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension blood pressure >= 140/90, active bleeding diatheses or active infection
Patient must not have any uncontrolled thyroid disease
Serious underlying medical condition that would impair the ability of the patient to receive protocol treatment, specifically cardiac diseases, uncontrolled hypertension or renal diseases
Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)
Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver or pancreatic surgery
CONTROL (HEALTHY) GROUP: Within the past month:\r\n* Heart attack\r\n* Unstable or stable angina (cardiac chest pain)\r\n* Left main coronary artery disease\r\n* Symptomatic heart failure\r\n* Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 100mm Hg)\r\n* Severe valvular heart disease\r\n* Uncontrolled metabolic disease (diabetes with fasting BS > 300 mg/dl, thyrotoxicosis, myxedema)\r\n* Aortic aneurism (> 45 mm diameter) or aortic dissection\r\n* Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise\r\n* Hypertrophic obstructive cardiomyopathy
Other uncontrolled immune-compromising illness
Uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (> 3 mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness
Uncontrolled concurrent medical condition likely to limit compliance with the study interventions
Patient has an active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
Has an uncontrolled chronic diarrheal illness
Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants
Individuals with uncontrolled renal insufficiency or renal failure
Uncontrolled hypothyroidism
Individuals with uncontrolled renal insufficiency or renal failure
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal or cardiac disease
Participants considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, corrected QT interval (QTc) prolongation > 470 msec, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease with less than 20% predicted lung function by diffusion capacity of the lungs for carbon monoxide (DLCO) (lung diffusion capacity testing), or any psychiatric disorder that prohibits obtaining informed consent
Patients with uncontrolled seizures
Significant comorbidity: ineligible participants include those with clinically significant and uncontrolled major cardiac, respiratory, renal hepatic, gastrointestinal, hematologic, or neurologic/psychiatric disease or disorder, including, but not limited to: active or uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or any other illness or condition that could exacerbate potential toxicities, confound safety assessment or limit compliance with study requirements
Uncontrolled or symptomatic hypercalcemia
Uncontrolled adrenal insufficiency
Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy
Patients who have any severe and/or uncontrolled medical conditions such as:
Subjects with life-threatening medical conditions that would preclude bronchoscopy, including: acute cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; or unstable coronary artery disease
uncontrolled dysrhythmias causing hemodynamic compromise,
Medical condition uncontrolled by treatment making completion of study unlikely
Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Medical condition uncontrolled by treatment making completion of study unlikely
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease)
Evidence of significant uncontrolled concomitant disease that in the opinion of the investigator could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
Any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
Evidence of severe uncontrolled systemic disease, bleeding diatheses, renal or liver transplant, active infection with hep B or C or HIV
Uncontrolled or unstable hyperthyroidism or Grave’s disease
Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease.
Patients with a history of uncontrolled seizures
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease], uncontrolled chronic renal diseases [glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis]), serious active infection or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension (blood pressure >= 140/90), active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus; screening for chronic conditions and infectious diseases is not required
Uncontrolled hypothyroidism
Patients with severe uncontrolled medical problems are not eligible for this trial.
Uncontrolled or unstable medical conditions
Significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease], uncontrolled chronic renal diseases [glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension (blood pressure >= 140/90), active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus; screening for chronic conditions is not required
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease)
No uncontrolled serious medical problems except for the diagnosis of cancer.
Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy in case re-initiation of dasatinib is needed.
The patient has another concurrent illness that would preclude study conduct and assessment, including, but not limited to, another active malignancy (excluding squamous or basal cell skin cancer and in situ cervical cancer), uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life threatening, or clinically significant), uncontrolled risk of bleeding, or uncontrolled diabetes mellitus.
Predisposing factors to retinal vein occlusion, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
Current severe, uncontrolled systemic disease
The participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
The participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
Uncontrolled/significant heart disease
Uncontrolled tumour-related pain or hypercalcemia
Uncontrolled lung disease
Serious concurrent uncontrolled medical disorder.
Patients with other major uncontrolled medical conditions, e.g., recent myocardial infarction, stroke, diabetes, active hepatitis