Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)\r\n* Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Concomitant diseases/conditions: Angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease, arrhythmia, immunodeficiency (including known HIV seropositive), ongoing or treatment-requiring chronic liver disease, active infection, oxygen requirement within two weeks prior to randomization, diffuse interstitial lung disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
Clinically significant cardiovascular disease or peripheral vascular (e.g. myocardial infarction, unstable angina within 6 months of study entry), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia requiring medications, baseline corrected QT (QTc) > 450 msec or previous history of QT prolongation while taking other medications
Clinically significant cardiac disease, including: NYHA Class III or IV congestive heart failure, unstable angina, acute myocardial infarction within six months of planned first dose, arrhythmia requiring therapy (including torsades de pointes, with the exception of extrasystoles, minor conduction abnormalities, or controlled and well treated chronic atrial fibrillation)
Clinically significant cardiac diseases, including any of the following:\r\n* Unstable angina pectoris\r\n* Myocardial infarction =< 3 months prior to registration\r\n* Other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension
Cardiac issues consisting of either symptomatic congestive heart failure (NYHA Class II or higher), unstable angina pectoris, myocardial infarction within 6 months, and/or cardiac arrhythmia, including atrial fibrillation (which is symptomatic or requires treatment).
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
Subject has clinically significant cardiac disease, including significant ischemic coronary disease, congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable arrhythmias, myocardial infarction or unstable angina within 6 months before randomization, a history of additional risk factors for torsades de pointes (eg, electrolyte abnormalities, family history of long QT syndrome), or a family history of sudden cardiac death before age 40
Severe, active co-morbidity defined as follows:\r\n* Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment\r\n* Known brain or central nervous system metastases or history of uncontrolled seizures\r\n* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from enrollment, New York Heart Association class III or IV congestive heart failure, and serious arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate)\r\n* Partial or complete gastrointestinal obstruction
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* New York Heart Association class III or IV cardiac disease, including pre-existing clinically significant arrhythmia, congestive heart failure, or cardiomyopathy\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
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =< 1 year or serious concurrent infection
Any significant medical conditions, laboratory abnormality, or psychiatric illness that would exclude the subject from participation or interfere with study treatment, monitoring and compliance such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association [NYHA] III or IV), myocardial infarction ? 6 months prior to first study drug, clinically significant and uncontrolled cardiac arrhythmia (e.g. atrial fibrillation/flutter ventricular cardiovascular physiology is allowed), cerebrovascular accidents ? 6 months before study drug start\r\n* Severely impaired lung function
Impaired cardiac function, uncontrolled cardiac arrhythmia, or clinically significant cardiac disease including the following: a) New York Heart Association grade III or IV congestive heart failure, b) myocardial infarction within the last 6 months
History of unstable or deteriorating cardiac or pulmonary disease (other than BOS) within the previous 6 months, including but not limited to the following:\r\n* Unstable angina pectoris or myocardial infarction\r\n* Congestive heart failure requiring hospitalization\r\n* Uncontrolled clinically significant arrhythmias
Clinically significant cardiac disease defined by any of the following criteria: a.) New York Heart Association (NYHA) class IV heart failure b.) N-terminal prohormone of brain natriuretic peptide (NT-ProBNP) > 8500 ng/L c.) Symptomatic orthostatic hypotension with supine systolic blood pressure < 90 mm Hg d.) Unstable cardiac arrhythmia e.) Unstable angina f.) Myocardial infarction within the past 6 months
Severe, active co-morbidity defined as follows:\r\n* Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment (with the exception of uncomplicated urinary tract infection [UTI])\r\n* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from enrollment, New York Heart Association class Ill or IV congestive heart failure, and serious arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate)\r\n* Partial or complete gastrointestinal obstruction
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: \r\n*Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device.
Any significant diseases medical condition, laboratory abnormality, or psychiatric illness that would exclude the subject from participate or interfere with study treatment, monitoring and compliance such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association [NYHA] III or IV), myocardial infarction =< 6 months prior to first study drug, clinically significant and uncontrolled cardiac arrhythmia (e.g. atrial fibrillation/flutter ventricular cardiovascular physiology is allowed), cerebrovascular accidents =< 6 months before study drug start\r\n* Severely impaired lung function
History of clinically significant cardiovascular disease including, but not limited to:\r\n* Myocardial infarction or unstable angina =< 6 months prior to treatment initiation.\r\n* Clinically significant cardiac arrhythmia.\r\n* Deep vein thrombosis, pulmonary embolism, stroke =< 6 months prior to treatment initiation.\r\n* Congestive heart failure (New York Heart Association class III-IV).\r\n* Pericarditis/clinically significant pericardial effusion.\r\n* Myocarditis.\r\n* Endocarditis.
(Bevacizumab-related exclusion) Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents =< 6 months prior to study enrolment, myocardial infarction =< 6 months prior to study enrollment, unstable angina, grade II or greater congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: \r\n* a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device \r\n* b) No myocardial infarction within 3 months of registration
Patients with following cardiac conditions will be excluded:\r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure\r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration =< 6 months prior to enrollment\r\n* History of severe non-ischemic cardiomyopathy with ejection fraction (EF) =< 20%
Patients with following cardiac conditions will be excluded:\r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure\r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\r\n* History of severe non-ischemic cardiomyopathy
Subject has clinically significant cardiac disease, including: myocardial infarction within 1 year before cycle 1, day 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association class III-IV); cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 grade 2 or higher) or clinically significant electrocardiogram (ECG) abnormalities; screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) > 470 msec
Impaired cardiac function, uncontrolled cardiac arrhythmia, or clinically significant cardiac disease including the following: a) New York Heart Association grade III or IV congestive heart failure, b) myocardial infarction within the last 6 months
Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (eg, prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram [ECG] changes) or uncorrected valvular disease and not primarily due to AL amyloid cardiomyopathy
Patients with clinically significant cardiac disease including one of the following currently or in the previous 6 months: myocardial infarction, unstable cardiac function due to unstable angina or congestive heart failure, congenital long QT syndrome, torsades de pointes or significant ventricular arrhythmias .
Evidence or history of significant cardiac disease (including evidence or history of significant cardiac disease (including myocardial infarction [MI] in the past 6 months, significant cardiac arrhythmia, stage III or IV congestive heart failure [CHF]); cardiac stress test will be done as clinically indicated; (the specific test to be chosen at the discretion of the principal investigator [PI])
Subject has clinically significant cardiac disease, including:\r\n* Myocardial infarction within 1 year before cycle 1 day 1, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association class III-IV)\r\n* Uncontrolled cardiac arrhythmia (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4 grade 2:2) or clinically significant electrocardiogram (ECG) abnormalities\r\n* Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) > 470 msec
History of cardiac disease, including: (a) myocardial infarction within 6 months of the start of study, (b) history of QTc prolongation or QTc >= 450 msec on screening EKG, history of additional risk factors for torsade de pointes (e.g., heart failure, hyperkalemia), and family history of long QT syndrome; (c) use of concomitant drugs that prolong QT/QTc interval; (d) New York Heart Association class III or IV heart disease, (e), active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically signification cardiac arrhythmia requiring therapy
Heart conditions - any of the following:\r\n* Any atrial fibrillation =< 3 months prior to registration\r\n* Unstable angina =< 12 months prior to registration\r\n* Prior symptomatic congestive heart failure\r\n* Documented myocardial infarction =< 6 months prior to registration (pretreatment electrocardiogram [ECG] evidence of infarct only will not exclude patients)\r\n* Prior significant ventricular arrhythmia requiring medication\r\n* Prior 2nd or 3rd degree heart block or other types of clinically significant conduction delay =< 6 months prior to registration\r\n* Clinically significant pericardial disease (including pericardial effusion, pericarditis) or cardiac valvular disease =< 12 months prior to registration\r\n* NOTE: As part of history and physical, all patients must be assessed for signs or symptoms of cardiac disease, or for prior history of cardiac disease; these conditions include but are not limited to diseases related to cardiac valves, pericardium, myocardium, atrioventricular delays or arrhythmias; it is strongly recommended that signs or symptoms of potentially clinically significant disease be evaluated with comprehensive cardiac echo
Active or unstable cardiac disease or heart attack within 3 months of starting study treatment
Cardiac syncope, uncompensated New York Heart Association (NYHA) class 3 or 4 congestive heart failure, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, severe orthostatic hypotension, or clinically important autonomic disease
History of heart failure or cardiac arrhythmia
Any of the following cardiac conditions: \r\n* Clinically significant heart disease (New York Heart Association [NYHA] class III or IV) or symptomatic congestive heart failure \r\n* Myocardial infarction =< 6 months prior to enrollment \r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration \r\n* History of severe non-ischemic cardiomyopathy with ejection fraction =< 20%
Significant cardiac event (eg, myocardial infarction), New York Heart Association (NYHA) classification of heart disease >= 2 within 12 weeks before starting treatment, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia
Known or suspected congestive heart failure, angina pectoris requiring antianginal medication, or other clinically significant cardiac condition
Patients must not have a history of myocardial infarction, severe or unstable angina, clinically significant peripheral vascular disease, grade 2 or greater heart failure, or serious and inadequately controlled cardiac arrhythmia
Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, must have a LVEF > 50% within 12 weeks prior to randomization.
Evidence of clinically significant cardiac disease at diagnosis, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac impairment due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
Congestive heart failure, clinically significant cardiac arrhythmia, history or current evidence of a myocardial infarction during the last 6 months, and/or a current electrocardiogram (ECG) tracing that is abnormal in the opinion of the treating Investigator, or unstable angina
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:\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
Adult patients (>= 18 years old) with the following cardiac conditions will be excluded: \r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure \r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\r\n* History of severe non-ischemic cardiomyopathy with ejection fraction (EF) =< 20%
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of >= 2), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia\r\n* Known history of congenital QT prolongation or Torsade de pointes (TdP)\r\n* Complete left bundle branch or bifascicular block\r\n* QTc interval > 450 ms for men or > 470 ms for women\r\n* Persistent or history of clinically meaningful ventricular arrhythmias or atrial fibrillation\r\n* Unstable pectoris or myocardial infarction =< 3 months prior to starting study treatment\r\n* Uncontrolled hypertension (blood pressure >= 160/95 mmHg)\r\n* Other clinically significant heart disease such as congestive heart failure requiring treatment
History of relevant coronary heart disease or myocardial infarction within last 3 years, NYHA Grade III or greater congestive heart failure, cerebro-vascular attack within the prior year, or serious cardiac arrhythmia requiring medication except atrial fibrillation.
Significant associated diseases including documented human immunodeficiency virus (HIV) infection, uncontrolled hypertension (diastolic blood pressures > 95%ile for age), unstable angina, congestive heart failure (> New York [NY] class II), poorly controlled diabetes (hemoglobin A1c [Hgb A1c] > 7%), coronary angioplasty within 6 months, myocardial infarction within the last 6 months, or uncontrolled atrial or ventricular cardiac arrhythmia, abnormal coagulation, persistent abnormal urinalysis reflecting intrinsic renal disease
Unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia, or need for antiarrhythmic medication for which inability to take an oral preparation of regular medication for 48 hours would represent an unacceptable risk
Patients with following cardiac conditions will be excluded: \r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure\r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\r\n* History of severe non-ischemic cardiomyopathy with ejection fraction (EF) =< 20%
Significant cardiac disease (i.e. uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous year) or serious cardiac arrhythmia requiring medication.
Cardiac disease (NYHA classes II-IV) including myocardial infarction within 6 months before enrollment, or unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment.
RENAL & BLADDER: History of clinically significant cardiovascular disease including, but not limited to:\r\n* Myocardial infarction or unstable angina ? 6 months prior to treatment initiation \r\n* Clinically significant cardiac arrhythmia\r\n* Deep vein thrombosis, pulmonary embolism, stroke ? 6 months prior to treatment initiation\r\n* Congestive heart failure (New York Heart Association class III-IV)\r\n* Pericarditis/clinically significant pericardial effusion\r\n* Myocarditis\r\n* Endocarditis
Subject has clinically significant cardiac disease, including: 1) myocardial infarction within 1 year before study enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association class III-IV); 2) uncontrolled cardiac arrhythmia or clinically significant electrocardiography (ECG) abnormalities; 3) screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) > 470 msec
Other medical conditions including but not limited to:\r\n* History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C\r\n* Active infection requiring parenteral antibiotics\r\n* New York Heart Association class II-IV congestive heart failure (serious cardiac arrhythmia requiring medication)\r\n* Myocardial infarction or unstable angina =< 6 months prior to registration\r\n* Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\r\n* Clinically significant peripheral vascular disease\r\n* History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.), clinically significant stroke or transient ischemic attack (TIA) =< 6 months prior to registration, seizures not controlled with standard medical therapy\r\n* Neuropathy ? grade 3
Subjects with clinically significant active ischemic heart disease, cardiac muscle disease (including cardiomyopathy or congestive heart failure) or myodegenerative disorders that may affect safe study participation
Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to, patients with congestive heart failure (New York Heart Association [NYHA] class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring > 2 medications for adequate control; diabetes mellitus with > 2 episodes of ketoacidosis in the preceding 12 months; or chronic obstructive pulmonary disease (COPD) requiring > 2 hospitalizations in the preceding 12 months
Unstable cardiovascular disease (eg, uncontrolled hypertension, peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute coronary syndrome) within 6 months of starting study treatment
Other medical conditions including but not limited to:\r\n* History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C\r\n* Active infection requiring parenteral antibiotics\r\n* Immuno-compromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\r\n* New York Heart Association class II-IV congestive heart failure (serious cardiac arrhythmia requiring medication)\r\n* Myocardial infarction or unstable angina =< 6 months prior to registration\r\n* Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\r\n* Clinically significant peripheral vascular disease\r\n* History of central nervous system (CNS) disease (e.g., primary brain tumor, vascular abnormalities, etc.), clinically significant stroke or transient ischemic attack (TIA) =< 6 months prior to registration, seizures not controlled with standard medical therapy\r\n* History of hypertensive crisis or hypertensive encephalopathy\r\n* Therapeutic anticoagulation requiring international normalized ratio (INR) > 2.0
Significant cardiac event (e.g., myocardial infarction), superior vena cava syndrome, New York Heart Association (NYHA) classification of heart disease >= 2 within 12 weeks, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia
Patients must not have serious intercurrent illness such as infection requiring intravenous (IV) antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Clinically significant cardiac disease, including:\r\n* >= Grade 2 myocardial infarction within 6 months prior to day 1 of protocol therapy\r\n* Unstable or uncontrolled disease condition relating to or affecting cardiac function (e.g. unstable angina, congestive heart failure, New York Heart Association Class III-IV) within 6 months prior to day 1 of protocol therapy\r\n* >= Grade 2 uncontrolled cardiac arrhythmia
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Patients with a history of cardiac disease including: (1) uncontrolled angina, congestive heart failure, or myocardial infarction within six months prior to study entry, (2) congenital long QT syndrome, (3) clinical significant ventricular arrhythmias
Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction\n             within 3 months of start of study treatment, serious uncontrolled cardiac arrhythmia\n             or any other clinically significant heart disease.
Patients with recent (? 6 months) cardiac angina, difficult to control congestive\n             heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias\n             will be excluded
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia\r\n* Patients with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drug should have an electrocardiogram (EKG) and echocardiogram performed to evaluate cardiac function as clinically indicated\r\n* Patients with evidence of congestive heart failure (CHF), myocardial infarction (MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab tests and cardiology consultations as clinically indicated including EKG, creatine phosphokinase (CPK), troponin, and echocardiogram
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with clinically significant cardiovascular disease; this includes: \r\n* Patients with significant cardiac conduction abnormalities, i.e. PR interval > 0.24 seconds (sec) or 2nd or 3rd degree atrioventricular (AV) block\r\n* Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg\r\n* Myocardial infarction, cardiac arrhythmia or unstable angina < 6 months prior to registration\r\n* New York Heart Association (NYHA) grade II or greater congestive heart failure\r\n* Serious cardiac arrhythmia requiring medication\r\n* Grade II or greater peripheral vascular disease (exception: episodes of ischemia < 24 hours [hrs] in duration, that are managed non-surgically and without permanent deficit)\r\n* History of cerebrovascular attack (CVA) within six months
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: \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
Medically documented cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, or severe orthostatic hypotension or clinically important autonomic disease.
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, and congestive heart failure related to primary cardiac disease, a history of a serious uncontrollable arrhythmia despite treatment, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
Significant cardiovascular disease, including: Active clinically symptomatic left ventricular failure,uncontrolled hypertension, myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug, history of serious ventricular arrhythmia, cardiac arrhythmias requiring anti-arrhythmic medications.
Clinically significant cardiac disease defined by CHF New York Heart Association (NYHA) Class > 1; uncontrolled clinically significant arrhythmia in last 6 months; Acute Coronary Syndrome (ACS) (angina or MI) in last 6 months.
Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, evidence of severe or systemic diseases, uncontrolled hypertension or history of cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), congestive heart failure . New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial, significant GI bleed within 30 days, metastatic brain disease, renal failure requiring dialysis
Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., subjects with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), symptomatic pulmonary embolism within 3 months, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia as determined by the treating physician.
Currently active, clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease within 6 months of screening
Medically documented cardiac syncope, uncompensated congestive heart failure, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant repetitive atrial or ventricular arrhythmias despite antiarrhythmic treatment, or severe orthostatic hypotension or clinically significant uncompensated autonomic insufficiency
Patients with any of the following conditions or complications are NOT eligible for participation:\r\n* Gastrointestinal (GI) tract disease resulting in an inability to take oral medication\r\n* Malabsorption syndrome\r\n* Require IV alimentation\r\n* History of prior surgical procedures affecting absorption\r\n* Uncontrolled inflammatory GI disease (e.g., Crohn’s, ulcerative colitis)\r\n* Hypersensitivity of any of the components of eribulin or lenvatinib\r\n* History of significant neurological (no neuropathy more than grade 2) or psychiatric disorders\r\n* Significant non neoplastic liver disease (cirrhosis, active chronic hepatitis)\r\n* Immunocompromised subjects, including patients with human immunodeficiency virus\r\n* Significant non neoplastic renal disease\r\n* Active infection requiring systemic therapy\r\n* Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment\r\n* Prolongation of corrected QT interval (QTc) to more than 480 milliseconds when electrolyte balance is normal\r\n* Major surgery within 4 weeks prior to first dose of the study drug
Patients who have any severe and/or uncontrolled cardiac disease within =< 6 months prior to start of everolimus, including: unstable angina pectoris, symptomatic congestive heart failure of New York Heart Association class III or IV, myocardial infarction, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
Known history of ischemic cardiac disease (including angina requiring anti-anginal medications, myocardial infarction, coronary artery disease documented on cardiac catheterization or ischemia documented on stress test), congestive heart failure, clinically significant arrhythmia or conduction system abnormalities, clinically significant valvular disease, clinically significant pericardial effusion or EF below the lower limit of normal
History of any significant cardiac event (e.g. myocardial infarction), superior vena cava syndrome, New York Heart Association (NYHA) classification of heart disease >= 2 within 12 weeks before starting treatment, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia
Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy
Myocardial infarction having occurred less than 6 months before inclusion, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications
Clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, congestive heart failure, or ongoing arrhythmias requiring medication or pacemaker
Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia
Significant or uncontrolled congestive heart failure (CHF), myocardial infarction, significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction.
Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system (e.g. active infection, clinically relevant impairment of cardiac function, severe heart failure/cardiac insufficiency, unstable angina pectoris or history of recent myocardial infarction), which in the opinion of the investigator precludes treatment with LDAC.
Clinically significant cardiovascular disease or cardiac insufficiency,cardiomyopathy, preexisting clinically significant arrhythmia, acute myocardial infarction within 3 months of enrolment, angina pectoris within 3 months of enrolment.
History of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including but not limited to congestive heart failure (NYHA Class 3 or 4), unstable angina; cardiac arrhythmia, recent (within past 6 months) myocardial infarction or stroke; uncontrolled hypertension; diabetes mellitus with >2 episodes of ketoacidosis in the preceding 12 months, COPD requiring >2 hospitalizations in preceding 12 months
Patients with known overt cardiac disease, including but not limited to a history of myocardial infarction, severe or unstable angina, clinically significant peripheral vascular disease, grade 2 or greater heart failure, or serious and inadequately controlled cardiac arrhythmia are not eligible
Patients with following cardiac conditions will be excluded:\r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure\r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\r\n* History of severe non-ischemic cardiomyopathy with ejection fraction (EF) =< 20%
Clinically significant cardiac disease (including symptomatic congestive heart failure, myocardial infarction, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia) within 1 year of study enrollment
Patients must not have significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
Patients with following cardiac conditions will be excluded: \r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure \r\n* Myocardial infarction =< 6 months prior to enrollment \r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration \r\n* History of severe non-ischemic cardiomyopathy with ejection fraction (EF) =< 20%
Any of the following concurrent medical conditions or history: \t   \r\n* Uncontrolled hypertension, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) class 2 or greater, clinically significant peripheral vascular disease, serious cardiac arrhythmia requiring medication\r\n* History of myocardial infarction (MI) or stroke within 6 months before enrollment\r\n* History of intra-abdominal abscess within 4 weeks before enrollment, abdominal fistula, gastrointestinal perforation, or active peptic ulcer disease\r\n* Evidence of bleeding diathesis or coagulopathy\r\n* Serious non-healing wound, ulcer or bone fracture
Myocardial infarction in the previous 12 weeks. Active ischemia or any other uncontrolled cardiac condition such as angina pectoris, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or CHF.
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =< 6 months prior to enrollment
Patient has had clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =< 1 year before randomization
Patients must not have clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =< 1 year before randomization
History of documented congestive heart failure, angina pectoris requiring medication, electrocardiogram (ECG) evidence of transmural myocardial infraction, poorly controlled hypertension, clinically significant valvular heart disease, or high-risk uncontrollable arrhythmias
No clinically significant history of cardiac disease, (i.e. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication)
Cardiac related illnesses including, but not limited to:\r\n* Symptomatic congestive heart failure including participants with grade III/IV cardiac disease as defined by the New York Heart Association functional criteria\r\n* Unstable angina pectoris\r\n* Cardiac arrhythmia
Heart failure or significant heart disease including significant arrhythmias, myocardial infarction within the last 3 months, unstable angina, documented ejection fraction < 30%, or current digoxin therapy
Clinically significant (i.e., active) cardiovascular disease, uncontrolled hypertension, unstable angina, history of myocardial infarction, cardiac failure class II-IV
Patient has in the opinion of the investigator any intercurrent conditions that could preclude their participation in the study, pose an undue medical hazard, or that could interfere with the interpretation of the study results, including, but not limited to, patients with congestive heart failure (NYHA Class III or IV; refer to Appendix III), unstable angina, cardiac arrhythmia requiring treatment, recent (within the prior 6 months) myocardial infarction, acute coronary syndrome or stroke, severe obstructive pulmonary disease, hypertension requiring more than2 medications for adequate control, or diabetes mellitus with more than 2 episodes of ketoacidosis in the prior 12 months.
History of significant cardiac disease. Includes second/third degree heart block; significant ischemic heart disease; mean QTc interval > 480 msec prior to study start; poorly controlled hypertension; congestive heart failure of NYHA Class II or worse
Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, any condition requiring anti-arrhythmic therapy, ischemic or valvular heart disease, or a myocardial infarction within the past 6 months
History of heart failure or serious cardiac arrhythmia
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to first study treatment, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities.*
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, uncontrolled hypertension, unstable ischemic coronary disease or congestive heart failure
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months of study entry, uncontrolled congestive heart failure, and uncontrolled arrhythmia. Subjects with congestive heart disease or arrhythmia such as atrial fibrillation whose cardiac disease is well controlled on a stable medical regimen are eligible.
Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome [SVC], New York Heart Association [NYHA] classification of heart disease >= 2 within 3 months before entry); or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia
Clinically significant cardiac disease as judged by the investigator including unstable angina, acute myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, and uncontrolled arrhythmia. Subjects with congestive heart disease or arrhythmias such as atrial fibrillation whose cardiac disease is well controlled on a stable medical regimen are eligible.
c. Significant cardiovascular dysfunction within the past 6 months including symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring hospitalization or emergency room visit within last 3 months
History of clinically significant cardiovascular disease including, but not limited to: \r\n* Myocardial infarction or unstable angina =< 6 months prior to treatment initiation \r\n* Clinically significant cardiac arrhythmia \r\n* Deep vein thrombosis, pulmonary embolism, stroke =< 6 months prior to treatment initiation \r\n* Congestive heart failure (New York Heart Association class III-IV) \r\n* Pericarditis/clinically significant pericardial effusion \r\n* Myocarditis \r\n* Endocarditis
Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
No history of serious cardiac disease that is not adequately controlled; patients with documented myocardial infarction within 6 months prior to study entry, congestive heart failure, unstable angina, clinically significant pericardial effusion or arrhythmia are ineligible; an electrocardiogram (ECG) must be done within 4 weeks prior to study entry on all patients
Any significant cardiac event(s) within the 12 months prior to registration, such as episode(s) of symptomatic congestive heart failure, myocardial infarction, unstable angina pectoris or persistent, stable angina pectoris, or cardiac arrhythmia requiring medication
Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome [SVC], New York Heart Association [NYHA] classification of heart disease >= 2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia
Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ?6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
History of congestive cardiac failure or an electrocardiography (EKG) suggesting significant conduction defect, or myocardial ischemia, or active psychiatric disease requiring treatment that would interfere with the understanding or conduct of the study
Patient has any of the following cardiac abnormalities (as determined by treating Doctor of Medicine [MD]):\r\n* Symptomatic congestive heart failure\r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* Unstable angina pectoris\r\n* Serious uncontrolled cardiac arrhythmia\r\n* Corrected QT interval (QTc) >= 480 msec (>= 500 msec in the presence of right bundle branch block [RBBB])
Patients must not have active significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure