Myocardial infarction or unstable angina pectoris within 6 months prior to randomization. Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry Acute myocardial infarction or angina pectoris. Unstable angina pectoris or myocardial infarction ? 3 months prior to starting treatment in the study. History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry; Unstable angina pectoris or acute myocardial infarction =< 3 months prior to starting study drug Unstable angina pectoris or acute myocardial infarction =< 3 months prior to starting study drug Have active angina pectoris or recent myocardial infarction (within 6 months). Acute myocardial infarction or unstable angina pectoris < 6 months prior to Screening Any active angina or any unstable angina pectoris or myocardial infarction within one year of study entry Angina pectoris =< 12 months prior to starting drug Have active angina pectoris, stroke or recent myocardial infarction (within 6 months). Acute myocardial infarction or angina pectoris ? 6 months prior to starting study drug Unstable angina pectoris or myocardial infarction ? 3 months prior to starting CC-122. Significant cardiac dysfunction; myocardial infarction within 12 months; unstable, poorly controlled angina pectoris. Acute myocardial infarction or unstable angina pectoris < 6 months prior to Screening History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry Unstable angina pectoris or myocardial infarction less than 6 months prior to starting either study drug Acute myocardial infarction (AMI) or unstable angina pectoris < 3 months prior to study entry Unstable angina pectoris or myocardial infarction ? 6 months prior to starting CC Acute myocardial infarction or angina pectoris ? 6 months prior to starting study drug Angina pectoris ? 3 months prior to starting study drug Have active angina pectoris, stroke or recent myocardial infarction (within 6 months). Subjects with any one of the following: 1) Congestive heart failure, 2) Myocardial infarction within 12 months prior to starting study treatment, 3) Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris Angina pectoris ? 3 months prior to dosing with study drug Acute myocardial infarction or angina pectoris ? 3 months prior to starting study drug History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening; Previous history of angina pectoris or acute myocardial infarction (MI) within 6 months Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within 6 months of registration 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 Subjects with significant or uncontrolled cardiovascular disease (e.g., uncontrolled hypertension, peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute coronary syndrome) within 6 months prior to starting study treatment or heart attack within 12 months prior to starting study treatment History of clinically significant cardiac dysfunction, including the following:\r\n* Current unstable angina\r\n* Current symptomatic congestive heart failure of New York Heart Association (NYHA) class 2 or higher.\r\n* Uncontrolled hypertension >= grade 2 (patients with a history hypertension controlled with anti-hypertensives to =< grade 1 are eligible).\r\n* Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower.\r\n* Uncontrolled arrhythmias.\r\n* Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack within the previous 6 months. History of clinically significant cardiac dysfunction, unless deemed to be direct result of disease, including the following:\r\n* Current unstable angina\r\n* Symptomatic congestive heart failure of New York Heart Association (NYHA) class 2 or higher\r\n* Uncontrolled hypertension > grade 2 (patients with history of hypertension controlled with anti-hypertensives to =< grade 2 are eligible\r\n* Left ventricular ejection fraction (LVEF) below institutional lower limit of normal or below 50%\r\n* Uncontrolled arrhythmias\r\n* Myocardial infraction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack within the previous 6 months 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) Cardiac disease: symptomatic congestive heart failure or radionuclide ventriculography (RVG), active angina pectoris, or uncontrolled hypertension Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association [NYHA] grade ? 2), uncontrolled hypertension or clinically significant arrhythmia currently requiring medical treatment Uncontrolled congestive heart failure or angina Subjects with uncontrolled (over the last 30 days) clinically significant confounding medical conditions such as congestive heart failure 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 ischemic heart disease, or uncontrolled symptomatic congestive heart failure History of cardiac disease: congestive heart failure>NYHA Class 2 or uncontrolled hypertension Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within 6 months of registration Uncontrolled or significant heart disorder such as unstable angina Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure Uncontrolled heart disease Uncontrolled cardiac disease, such as uncontrolled hypertension, unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months Other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ? 160/95 mmHg). Severe or uncontrolled medical disease, including uncontrolled diabetes, congestive heart failure, chronic renal disease or chronic pulmonary disease 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 Subject has an ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, active bleeding or any other serious uncontrolled medical disorder Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ?2), uncontrolled hypertension or clinically significant arrhythmia currently requiring medical treatment Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure Known congestive heart failure, significant ventricular arrhythmias, cirrhosis, grade 4/5 chronic kidney disease, uncontrolled diabetes Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. 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) The patient has a history of uncontrolled angina, arrhythmias, or congestive heart failure Other clinically significant heart disease (e.g. uncontrolled congestive heart failure or uncontrolled hypertension) 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 clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension) Clinically significant history of cardiovascular disease (history of unstable angina, congestive heart failure, uncontrolled hypertension, myocardial infarction or valvular heart disease) Clinically significant and/or uncontrolled heart disease such as congestive heart failure (CHF) requiring treatment (NYH grade ?2), hypertension or arrhythmia 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 7. Uncontrolled congestive heart failure or uncontrolled hypertension. Uncontrolled arrhythmia or heart failure 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 Evidence of poor cardiovascular function defined as b-type natriuretic peptide (BNP) > 100 pg/mL, or history of congestive heart failure, unstable angina, uncontrolled hypertension, or clinically significant ventricular arrhythmias at screening; 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). Unstable angina or uncontrolled congestive heart failure Clinically significant, uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias) Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension Uncontrolled heart failure in the last week Does not have clinically significant, symptomatic uncontrolled heart disease (e.g., unstable angina, congestive heart failure, or uncontrolled hypertension) 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 Unstable angina or uncontrolled congestive heart failure 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 uncontrolled symptomatic heart failure, Other clinically significant heart disease (e.g. congestive heart failure, cardiomyopathy or uncontrolled hypertension) With the exception of treatment-naïve elderly AML patients, patients with uncontrolled congestive heart failure (CHF), coronary heart disease (CAD), chronic obstructive pulmonary disease (COPD), or left ventricular ejection fraction (LVEF) of ? 50% are excluded, symptomatic or uncontrolled arrhythmias or on continuous corticosteroids. Uncontrolled/significant heart disease Patients with cardiac diseases ongoing or in the past 6 months (e.g. congestive heart failure, acute myocardial infarction, significant uncontrolled arrhythmias) are not eligible for this trial Patient must have no history of recent myocardial infarction (within three months), uncontrolled congestive heart failure, or uncontrolled cardiac arrhythmia Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Patients who have evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months are not eligible 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 Evidence of current uncontrolled cardiovascular conditions, including but not limited to clinically significant cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction, within the past 6 months Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months; recent history of myocardial infarction in the six months prior to registration Patients with cardiac diseases ongoing or in the past 6 months (e.g. congestive heart failure, acute myocardial infarction, significant uncontrolled arrhythmias) are not eligible for this trial Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months; patients experiencing an isolated cardiac complication at the time of transplant who have been evaluated by cardiology and remained stable for at least 60 days are eligible Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months; Note: prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months 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 Patients with a history of myocardial infarction within the last 6 months or unstable / uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias Absence of unstable cardiac disease defined as myocardial infarction with 6 months, uncontrolled heart failure, or uncontrolled cardiac arrhythmia Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction =< 6 months; Note: Prior to entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant Has significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, uncontrolled arrhythmias, or severe valvular heart disease, or a myocardial infarction within 6 months prior to the first dose of study treatment Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction =< 6 months prior to registration Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, myocardial infarction within the past 6 months or serious uncontrolled cardiac arrhythmia are not eligible Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months 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 Evidence of current uncontrolled cardiovascular conditions, including uncontrolled cardiac conditions such as hypertension, or cardiac arrhythmias, or New York Heart Association stage III and IV congestive heart failure, or unstable angina or myocardial infarction within the past 6 months Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, cardiac arrhythmias, or congestive heart failure, and unstable angina or myocardial infarction within the past 6 months Severe or uncontrolled, concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) Cardiac disease ongoing or in the past 6 months (e.g. congestive heart failure, acute myocardial infarction, significant uncontrolled arrhythmias) Patients with severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) 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. Patients with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, myocardial infarction within the past 6 months or serious uncontrolled cardiac arrhythmia are not eligible Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months; Note: prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. 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. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, serious cardiac arrhythmia requiring medication (other than adequately rate-controlled atrial fibrillation), symptomatic congestive heart failure, unstable angina, stroke/transient ischemic attack (TIA) within the past 6 months or myocardial infarction within the past 6 months Patients who have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, uncontrolled arrhythmia, severe pulmonary disease or requirement of supplemental oxygen) 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 Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months CLINICAL/LABORATORY CRITERIA: Patients must not have history of significant co-morbid illness inclusive of but not restricted to uncontrolled congestive cardiac failure, uncontrolled hypertension, history of myocardial infarction, unstable angina, coronary angioplasty, stenting or cerebrovascular accident within 6 months prior to registration or any other illness that in the assessment of the treating physician would compromise the ability of the patient to participate in this study The patient has clinically significant cardiovascular disease (e.g., uncontrolled or any NYHA Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication). Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit 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 Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. Has one of the following cardiac-related conditions: Congestive heart failure; angina pectoris; myocardial infarction (within 1 year of study start); uncontrolled hypertension; or uncontrolled arrhythmias Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months\r\n* Chronic hypertension on medical therapy does not constitute an exclusion criterion Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months 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 Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Uncontrolled angina within 6 months Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, myocardial infarction within the past 6 months or serious uncontrolled cardiac arrhythmia are not eligible Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months History of acute myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure 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 Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within 6 months before randomization in the study. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months; Note: prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant 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 The subject has uncontrolled significant intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris within 6 months, stroke within 6 months, myocardial infarction within 6 months, or uncontrolled cardiac arrhythmias, uncontrolled hypertension Have one of the following cardiac-related conditions: Congestive heart failure or angina pectoris (except if medically controlled); myocardial infarction (within 1 year of study start); uncontrolled hypertension; or uncontrolled arrhythmias Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months 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 Patients with serious medical illnesses, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within six months prior to study entry Patients with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, history of myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia. Patients with history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with an ejection fraction under 40%. Uncontrolled or symptomatic angina 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. History of uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months, untreated known coronary artery disease, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction Patients with preexisting cardiac conditions, including uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure will not be eligible History of or current cardiovascular risk including myocardial infarction, ? Class II congestive heart failure, uncontrolled arrhythmias, or refractory hypertension The subject has uncontrolled significant intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris within 6 months, stroke within 6 months, myocardial infarction within 6 months, or uncontrolled cardiac arrhythmias, uncontrolled hypertension Congestive heart failure or uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or dysrhythmias. 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 Current uncontrolled cardiac disease; i.e., uncontrolled hypertension (diastolic blood pressure [BP] > 100 or systolic > 180), unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction (=< 45%); transmural myocardial infarction within the last 6 months Cardiovascular Acute myocardial infarction Congestive heart failure - (NYHA criteria for uncontrolled) Clinically significant cardiac arrhythmias - uncontrolled No history of myocardial infarction =< 6 months prior to registration; no current symptomatic congestive heart failure, uncontrolled angina, or uncontrolled cardiac arrhythmias Significant history of uncontrolled cardiac disease defined as uncontrolled hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomization. Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Significant history of uncontrolled cardiac disease defined as uncontrolled hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months Subjects with any of the following cardiovascular conditions within the past 6 months\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Cardiac arrhythmia\r\n* Admission for unstable angina\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible Patients with a history of any one or more of the following cardiovascular conditions within the past 6 months prior to study enrollment are NOT eligible for participation:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association History of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac or vascular surgery within 6 months prior to day 1 of study treatment History of any of the following cardiovascular conditions within 12 months of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association Class III or IV heart failure as defined by the New York Heart Association (NYHA), history of cardiac angioplasty or stenting, documented myocardial infarction or unstable angina within 6 months prior to enrollment, cardiac ejection fraction of < 45%, or other clinically significant cardiac disease History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease 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 3 months; coronary angioplasty, or stenting or bypass grafting within the past 6 months; cardiac ventricular arrhythmias requiring medication; any history of second (2nd) or third (3rd) degree atrioventricular conduction defects) History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment History of myocardial infarction, New York Heart Association (NYHA) class III or IV congestive heart failure, arrhythmia requiring therapy, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to the start of study drug History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease Arterial or venous thrombi (including stroke), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting. Clinically significant cardiovascular abnormalities such as:\r\n* Corrected QT interval (QTc) >= 470 msec\r\n* Angina not well-controlled by medication\r\n* Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac/vascular stenting within 6 months of enrollment\r\n* Symptomatic or documented congestive heart failure that meets New York Heart Association (NYHA) class III to IV definitions\r\n* History of stroke within the last 6 months prior to screening History of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, or unstable angina; history of other clinically significant cardiac disease that, in the opinion of the PI or designee, is a contraindication to lymphodepleting chemotherapy, JCAR014 infusion, or durvalumab infusion is also excluded Clinically significant atherosclerotic cardiovascular disease including patients with New York Heart class II/III/IV congestive heart failure (CHF), ventricular arrhythmias requiring medication, myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary artery bypass grafting, angioplasty, cardiac or other vascular stenting within the past 6 months History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure as defined by the New York Heart Association History of any one or more of the following cardiovascular conditions within the past 6 months: \r\n* Cardiac angioplasty or stenting \r\n* Myocardial infarction \r\n* Unstable angina \r\n* Coronary artery bypass graft surgery \r\n* Symptomatic peripheral vascular disease Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to administration of first dose of study drug. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to day 1 of study treatment; History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease History of any of the following cardiovascular conditions within 6 months of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, class III or IV congestive heart failure as defined by the New York Heart Association, symptomatic peripheral vascular disease, cerebrovascular accident, or transient ischemic attack History of any of the following cardiovascular conditions within the past 6 months:\r\n* Class III or IV congestive heart failure as defined by the New York Heart Association Criteria\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Symptomatic peripheral vascular disease or other clinically significant cardiac disease History of any of the following cardiovascular conditions within 12 months of screening:\r\n* Myocardial infarction\r\n* Unstable angina pectoris\r\n* Cardiac angioplasty or stenting\r\n* Coronary/peripheral artery bypass graft\r\n* Class III or IV congestive heart failure per New York Heart Association\r\n* Cerebrovascular accident or transient ischemic attack Any of the following conditions =< 6 weeks prior to registration:\r\n* Cerebrovascular accident (CVA)\r\n* Admission for unstable angina\r\n* Cardiac angioplasty or stenting or coronary artery bypass graft surgery\r\n* Untreated pulmonary embolism or untreated deep venous thrombosis (DVT)\r\n* Arterial thrombosis\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system Subjects with any of the following cardiovascular conditions within the past 6 months\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Admission for unstable angina\r\n* Myocardial infarction\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible\r\n* Active cardiac arrhythmia (except sinus arrhythmia, atrial fibrillation, asymptomatic premature ventricular contractions [PVCs])\r\n* Ejection fraction < institutional lower limit of normal (LLN) and/or history of cardiomyopathy Patients with any of the following cardiovascular conditions within the past 6 months:\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Admission for unstable angina\r\n* Myocardial Infarction\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT), or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Note: a patient who has a history of class III heart failure and is asymptomatic on treatment may be considered eligible for the study Patient must have no history of myocardial infarction, hospital admission for unstable angina, cardiac angioplasty or stenting within 6 months of randomization History of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral arterial vascular disease History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure as defined by the New York Heart Association Cardiac angioplasty or stenting History of any one or more of the following cardiac conditions within the past 6 months: Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; History of Class III or IV congestive heart failure according to New York Heart Association classification History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery =< 6 months prior to registration History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery =< 12 months prior to randomization The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months of randomization. Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic, or history of documented congestive heart failure (New York [NY] Heart Association functional classification III-IV)\r\n* Corrected QT interval using Fridericia's formula (QTcF) > 470 msec\r\n* Angina not well-controlled by medication\r\n* Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac or vascular stenting in the past 6 months Cardiac angioplasty or stenting History of any one or more of the following cardiovascular conditions within the past 12 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease History of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of any one or more of the following conditions within 6 months of registration:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Pneumonitis History of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease History of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery by-pass graft surgery\r\n* Symptomatic peripheral vascular disease Subjects with any of the following cardiovascular conditions within the past 6 months:\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Cardiac arrhythmia\r\n* Admission for unstable angina\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of Class II heart failure\tand is asymptomatic on treatment may be considered eligible History of any one or more of the following cardiovascular conditions within the past 6 months: \r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina \r\n* Coronary artery bypass graft surgery \r\n* Symptomatic peripheral vascular disease \r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV. History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease History of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting; myocardial infarction; unstable angina; coronary artery bypass graft surgery; symptomatic peripheral vascular disease; class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of clinically significant cardiovascular condition with the past 6 months (e.g. angioplasty or stenting, myocardial infarction, unstable angina, bypass surgery, symptomatic peripheral arterial disease [PAD], class III or IV congestive heart failure) Significant cardiac conditions (myocardial infarction [heart attack], unstable angina, coronary angioplasty, cardiac bypass) or serious arrhythmia within 6 months Significant cardiovascular disease such New York Heart Association (NYHA) class III or greater, myocardial infarction within the previous 3 months, unstable arrhythmias, unstable angina, need for cardiac angioplasty or stenting, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease; subjects with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction < 50% must be on a stable regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist when appropriate History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease Patients must not have history of any one or more of the following cardiovascular conditions within the past 6 months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) No angina or myocardial infarction within 182 days of registration; in view of potential cardiac risk with lenalidomide, patients with stable angina will be excluded History of myocardial infarction or unstable angina within 12 months prior to day 1 Patients with myocardial infarction or unstable angina < 6 months prior to starting study drug Unstable angina or myocardial infarction. Must not have a history of myocardial infarction, severe or unstable angina, peripheral vascular disease or familial QT prolongation Myocardial infarction of unstable angina within 6 months prior to the planned start date of study drug. Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol e.g. unstable angina, myocardial infarction within 6 months, severe infection, etc. Myocardial infarction or unstable angina within 6 months of the first date of treatment on this study. History of cerebral vascular accident, unstable angina, myocardial infarction, or ventricular arrhythmia within the last 6 months Having known myocardial infarction or unstable angina within 6 months before first ZW25 dosing History of myocardial infarction or unstable angina within 6 months of registration History of myocardial infarction or unstable angina within 6 months prior to day 1 Has a history of myocardial infarction or unstable angina within 6 months before enrollment Patients with unstable angina and/or myocardial infarction within 6 months prior to screening History of myocardial infarction or unstable angina within 6 months prior to first study treatment Unstable angina or a history of myocardial ischemia within prior 6 months History of myocardial infarction or unstable angina within 3 months prior to cycle 1, day 1 Myocardial infarction or unstable angina within 6 months of enrollment Myocardial infarction within the past 12 months, or stable or unstable angina History of myocardial infarction or severe unstable angina Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment. History of myocardial infarction or unstable angina within 6 months prior to study enrollment History of myocardial infarction or unstable angina within the past 12 months History of myocardial infarction or unstable angina within 6 months prior to day 1 Patients with a myocardial infarction or unstable angina within 6 months of study entry Unstable angina or a history of myocardial ischemia within prior 6 months Myocardial infarction or uncontrolled angina within 6 months History of a stroke, myocardial infarction, or unstable angina in the previous 6 months Has a medical history of myocardial infarction or unstable angina History of myocardial infarction within 6 months or unstable angina within the past 6 months. History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months Myocardial infarction or unstable angina less than 6 months before registration History of myocardial infarction or unstable angina within 6 months prior to Day 1 Must not have a history of myocardial infarction, severe or unstable angina, or peripheral vascular disease Myocardial infarction or unstable angina < 6 months prior to registration History of myocardial infarction or unstable angina within 6 months prior to study enrollment Unstable angina and/or myocardial infarction within 6 months prior to screening History of myocardial infarction (within 12 months) or unstable angina (within 6 months) prior to study enrolment. Patients are excluded if they have a history of myocardial infarction or unstable angina within 6 months prior to randomization History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months; Unstable angina or new-onset angina (begun within the last 3 months), or myocardial infarction within the 6 months prior to enrollment Myocardial infarction or unstable angina within 6 months prior to registration. Diagnosis of unstable angina or myocardial infarction within 6 months of study entry Patients with a history of stroke, myocardial infarction, or unstable angina within 6 months prior to registration are not eligible Myocardial infarction or unstable angina within 6 months prior to Day 1 of the study. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction less than 6 months prior to randomization History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months Myocardial infarction or unstable angina within 6 months prior to the first dose of study drug. History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug History of myocardial infarction or unstable angina within 6 months prior to study Day History of myocardial infarction or unstable angina within 6 months prior to day 1 History of myocardial infarction or unstable angina within 6 months prior to day -3 Patients with myocardial infarction or unstable angina =< 6 months prior to starting study drug Patients with myocardial infarction or unstable angina =< 6 months prior to registration History of myocardial infarction or unstable angina within 12 months prior to day 1 History of myocardial infarction or unstable angina within 6 months prior to enrollment. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study treatment Myocardial infarction or uncontrolled angina within 3 months; History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months History of myocardial infarction or unstable angina within 6 months prior to Day 1 Active coronary artery disease, unstable or newly diagnosed angina or myocardial infarction less than 6 months prior to first study drug administration Has a medical history of myocardial infarction or unstable angina. History of myocardial infarction or unstable angina within 6 months prior to first study treatment unstable angina or myocardial infarction within 6 months of enrollment. Patients with myocardial infarction or unstable angina =< 6 months prior to starting study drug Patients with myocardial infarction or unstable angina ? 6 months prior to starting study drug. Myocardial infarction or unstable angina < 6 months prior to enrollment History of unstable angina or myocardial infarction within 12 months prior to Day 1 or ischemic heart disease. Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug History of myocardial infarction within 6 months prior to Cycle 1, Day 1, or history of unstable angina History of myocardial infarction or unstable angina within 6 months of enrollment Unstable angina or myocardial infarction within 6 months prior to first dose History of myocardial infarction, acute inflammatory heart disease, unstable angina, or uncontrolled arrhythmia within the past 6 months. History of myocardial infarction, severe or unstable angina, peripheral vascular disease or familial QTc prolongation. Transmural myocardial infarction or unstable angina within 3 months prior to study registration History of myocardial infarction or uncontrolled angina within 12 months prior to administration of study drug Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug; Unstable angina or myocardial infarction within 6 months of enrolment, History of myocardial infarction within 6 months before Cycle 1, Day 1, or history of unstable angina Myocardial infarction or unstable angina within 6 months of day 1 prior to registration Significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months, History of a stroke, myocardial infarction, or unstable angina in the previous 6 months Significant cardiovascular disease, such as cardiac disease, myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina History of myocardial infarction or unstable angina within 6 months prior to day 1 Myocardial infarction or unstable angina within 6 or 1 month of starting nintedanib treatment, respectively History of unstable angina or myocardial infarction in the last week History of unstable angina or myocardial infarction 1 month prior to study enrollment History of myocardial infarction or unstable angina within 12 months prior to day 1 No unstable angina, regular use of nitroglycerin for exertional angina, or myocardial infarction (MI) within the last 12 months History of unstable angina or myocardial infarction 1 month prior to study enrollment History of unstable angina or myocardial infarction 1 month prior to study enrollment Patients with myocardial infarction or unstable angina < 6 months prior to starting study Medically eligible to use nicotine replacement therapy (patient currently hospitalized with acute myocardial infarction/ST elevation myocardial infarction [STEMI], unstable angina, uncontrolled arrhythmia, stroke, peripheral arterial disease vascular surgery will not be eligible for inclusion) Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control Unstable angina. Unstable angina within 6 months prior to study entry, Unstable cardiac disease, including unstable angina or unstable hypertension, or need to change medication within 6 weeks of provision of consent due to lack of disease control Significant cardiovascular disease, within 3 months prior to randomisation, unstable arrhythmias, or unstable angina Severe/unstable angina within the 6 months prior to study drug administration Unstable cardiac disease, including unstable angina or unstable hypertension, as defined by the need for change in medication for lack of disease control within the last three months Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) Severe/unstable angina Unstable angina Unstable angina within 6 months prior to first dose; Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization) Uncontrolled hypertension or unstable angina. Unstable angina within 6 months prior to study entry Unstable angina or new-onset angina Current unstable angina. Unstable angina or angina requiring surgical or medical intervention; and/or unstable angina (angina symptoms at rest) within less than or equal to 3 months prior to randomization; and Unstable angina or angina requiring surgical or medical intervention; and/or Unstable angina. Significant cardiac arrhythmia or unstable angina or angina requiring surgical or medical intervention; and/or Unstable angina within the last 6 months prior to registration Unstable angina within 6 months prior to first dose Unstable angina Patients with unstable angina or serious arrhythmia History of unstable angina within 1 year prior to study entry Unstable angina Unstable angina Grade >= 2 heart failure or history of unstable angina Unstable angina Unstable angina Unstable angina Unstable angina Unstable angina defined as angina (or anginal equivalent) 2 or more times per week despite medical therapy. Unstable angina Unstable cardiac disease, including unstable angina or unstable hypertension, as defined by the need for change in medication for lack of disease control within the last three months If they have angina or unstable coronary disease Have unstable angina Angina Unstable angina or angina requiring surgical or medical intervention; and/or unstable angina, Unstable angina Unstable angina Unstable angina Patients with unstable occlusive disease (eg, crescendo angina) History of unstable angina within 1 year of study entry Unstable angina Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events in the past 6 months, severe or unstable angina, class III-IV New York Heart Association heart failure Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes), New York Heart Association (NYHA) class III-IV heart disease or cardiac ejection fraction measurement of < 40% at baseline Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of < 35 % at baseline, if done Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of < 35 % at baseline 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 Active co-morbidity, defined as follows:\r\n* Chronic liver disease with cirrhosis (Child-Pugh B or C) or active hepatitis B or C\r\n* History of pituitary or adrenal dysfunction\r\n* Poorly controlled diabetes mellitus (A1c > 9% or history of complications including peripheral neuropathy, end organ damage, hospitalization, amputation)\r\n* Poorly controlled glaucoma\r\n* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class III-IV heart disease or known cardiac ejection fraction measurement of < 50% at baseline\r\n* Clinical evidence of active infection of any type, including active or symptomatic viral hepatitis\r\n* Known immune deficiency and/or human immunodeficiency virus (HIV)-positive patients\r\n* Any medical condition that warrants long-term corticosteroid use in excess of study dose clinically significant heart disease including but not limited to: myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or known cardiac ejection fraction measurement of < 50 %; Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class III-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline 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 corrected QT (QTc) interval > 470 msec 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 corrected QT (QTc) interval > 470 msec Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, unstable atrial fibrillation, or New York Heart Association (NYHA) class III-IV heart disease Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or known cardiac ejection fraction measurement of < 50 % at baseline Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of < 45 % at baseline, if done Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association class III-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline Clinically significant heart disease as evidenced by myocardial infarction or arterial thrombotic event within the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association class III-IV heart disease or cardiac ejection fraction measurement of < 50% Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline Patients who have the following risk factors are considered to be at increased risk for cardiac toxicity and must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution’s lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* A New York Heart Association (NYHA) classification of II controlled with treatment\r\n* Prior central thoracic radiation therapy (RT), including RT to the heart.\r\n* History of myocardial infarction within 12 months (patients with history of myocardial infarction within 6 months are excluded) No clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollment History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function within 6 months prior to randomization; history of documented CHF; or documented cardiomyopathy. Ischemic cardiac event including myocardial infarction within 3 months prior to first dose Myocardial infarction within 6 months of course 1 day 1 (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate Patients must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution’s lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months prior to registration if they have any of the following risk factors for cardiac toxicities:\r\n* A New York Heart Association (NYHA) classification of II controlled with treatment \r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 12 months prior to registration\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* Prior history of other significant impaired cardiac function Significant cardiac disease such as recent myocardial infarction Patient has any unstable or uncontrolled medical condition that would make it potentially unsafe to undergo TURBT including a previous stroke or myocardial infarction within 6 months Ischemic cardiac event including myocardial infarction within 3 months prior to first dose; 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 Patients who have the following risk factors are considered to be at increased risk for cardiac toxicities, and must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution’s lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* A New York Heart Association (NYHA) classification of II controlled with treatment\r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 12 months (patients with history of myocardial infarction within 6 months are excluded from the study) History of an ischemic cardiac event including myocardial infarction within 3 months of study entry Significant cardiac abnormalities such as:\r\n* Myocardial infarction within 3 months of course 1 day 1 (C1D1); (subjects with a history of myocardial infarction between 3 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment [treadmill stress test, nuclear medicine stress test, or stress echocardiogram] since the event, may participate);\r\n* An electrocardiogram (ECG) recorded at screening showing evidence of cardiac ischemia (ST depression of >= 2 mm, measured from isoelectric line to the ST segment); if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not coronary artery disease (CAD) is present;\r\n* Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class III to IV definitions and/or ejection fraction < 30% by multigated acquisition scan (MUGA) scan or < 50% by echocardiogram and/or magnetic resonance imaging (MRI) Myocardial infarction within 1 year of study entry; subjects with a history of myocardial infarction between 6 and 12 months prior to study entry who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines\r\n* Patients with the following risk factors should have a baseline cardiac function assessment:\r\n** Prior treatment with anthracyclines\r\n** Prior treatment with trastuzumab\r\n** Prior central thoracic radiation therapy (RT), including RT to the heart\r\n** History of myocardial infarction within 6 to 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)\r\n** Prior history of impaired cardiac function History of cardiac infarction within the past 12 months prior to the start of study treatment History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; history of documented congestive heart failure (CHF); and documented cardiomyopathy Patients experiencing a cardiac events (acute coronary syndrome, myocardial infarction, or ischemia) within the 3 months prior to accrual Prior myocardial infarction within one year of study entry Known history of Torsade de Pointes, unstable cardiac arrhythmia or proarrhythmic conditions, or a history of recent myocardial infarction within 90 days of study entry. History of myocardial infarction within 6 months with a residual arrhythmia that in the opinion of the investigator, increases the risk of ventricular arrhythmia Significant cardiac disease such as recent myocardial infarction Myocardial infarction, cardiac arrest or cardiac failure within 1 year before screening/baseline visit; Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines\r\n* Patients with the following risk factors should have a baseline cardiac function assessment:\r\n** Prior treatment with anthracyclines\r\n** Prior treatment with trastuzumab\r\n** Prior central thoracic radiation therapy (RT), including RT to the heart\r\n** History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study)\r\n** Prior history of impaired cardiac function Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction\n during the previous 6 months Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of randomization Left ventricular ejection fraction (LVEF) < lower limit of normal (LLN) per institutional guidelines, or <55%, if threshold for normal not otherwise specified by institutional guidelines, for patients with the following risk factors: Prior treatment with anthracyclines; Prior treatment with trastuzumab; Prior central thoracic RT, including exposure of heart to therapeutic doses of ionizing RT; History of myocardial infarction within 6-12 months prior to start of IPs; Prior history of other significant impaired cardiac function Patients with any of the following risk factors should have a baseline cardiac function assessment:\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 6 to 12 months (patients with history of myocardial infarction within 6 months are excluded from the study\r\n* A NYHA classification of II controlled with treatment\r\n* Prior history of impaired cardiac function Myocardial infarction within 6 months of cycle one, day one (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate History of myocardial infarctions or cardiac stent placement less than 1 year before recruitment into the study History or clinical signs of myocardial infarction within 1 year prior to study entry 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 Patients who have the following risk factors are considered to be at increased risk for cardiac toxicities; these patients should have increased monitoring:\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* A New York Heart Association classification of II controlled with treatment\r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 12 months (patients with history of myocardial infarction within 6 months are excluded from the study) No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina; patients who are over 40 or have had previous myocardial infarction greater than 6 months prior to entry will be required to have a negative or low probability cardiac stress test for cardiac ischemia Echocardiogram should be done within 7 days of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction) Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment Hemodynamically unstable patients (not in cardiogenic shock or having an acute myocardial infarction [MI]) Patients who are over 40 years old or have had previous myocardial infarction greater than 6 months prior to study entry or have significant cardiac family history (coronary artery disease [CAD] or serious arrhythmias) will be required to have a negative or low probability cardiac stress test (for example, thallium stress test, stress multigated acquisition scan [MUGA], stress echo or exercise stress test) for cardiac ischemia within 8 weeks prior to registration Myocardial infarction within 6 months of cycle 1 day 1 (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina\r\n* Patients who are over 40 years old or have had previous myocardial infarction greater than 6 months prior to study entry or have significant cardiac family history (coronary artery disease [CAD] or serious arrhythmias) will be required to have a negative or low probability cardiac stress test (for example, thallium stress test, stress multi-gated acquisition scan [MUGA], stress echocardiography [echo], or exercise stress test) for cardiac ischemia within 8 weeks prior to registration\r\n* An echocardiogram should be performed at baseline in all patients; ejection fraction (EF) from baseline echocardiogram must be within the institutional limits of normal as determined by the reading cardiologist; if the baseline cardiac stress test incorporates an echocardiogram, then this will not need to be done again at baseline Myocardial infarction within one year prior to study entry. Significant cardiac disease (i.e., left ventricular ejection fraction of < 50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months) Unstable cardiac disease or myocardial infarction within 6 months prior to study entry History of an ischemic cardiac event including myocardial infarction within 3 months of study entry Unstable cardiac disease or myocardial infarction within 6 months prior to study entry Patients with a history of myocardial infarction are eligible if the event occurred > 6 months prior to entry History or clinical signs of myocardial infarction within 1 year of study entry History of cardiac disease: congestive heart failure (CHF) > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > Class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization History of cardiac disease: congestive heart failure (CHF) > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction or coronary stenting within 6 months prior to randomization; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (angina symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Active or clinically significant cardiac disease including:\r\n* Congestive heart failure-New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization unstable angina (anginal symptoms at rest) or new onset angina (i.e., began within the last 3 months). Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease including unstable or newly diagnosed angina or myocardial infarction within 6 months prior to study entry\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Corrected QT interval (QTc) (Fridericia) > 450 msec on two consecutive electrocardiograms (ECGs) (baseline ECG should be repeated if QTc is found to be > 450 msec) FOR ALL PHASES (Ib AND II): History of significant cardiac disease:\r\n* Congestive heart failure > New York Heart Association (NYHA) class 2\r\n* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) \r\n* Myocardial infarction less than 6 months before start of test drug\r\n* Anti-arrhythmic therapy (beta blockers or digoxin are permitted) Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Suspected long QT syndrome defined as corrected QT (QTc) interval > 500 milliseconds at baseline\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Pre-existing cardiac conditions as outlined below:\r\n* Congestive heart failure >= New York Heart Association (NYHA) class 2\r\n* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months); myocardial infarction less than 6 months before the start of study treatment\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Patients with cardiac disease defined as one of the following are not eligible:\r\n* Congestive heart failure > class II New York Heart Association (NYHA)\r\n* Unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months)\r\n* Myocardial infarction within the past 6 months Active or clinically significant cardiac disease including any of the following:\r\n* Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment\r\n* Myocardial infarction within 6 months prior to initiating study treatment\r\n* New York Heart Association (NYHA) class III or IV congestive heart failure Active or clinically significant (or symptomatic) cardiac disease, including active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin within the last 3 months, unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before study day 0 Active or clinically significant cardiac disease including any of the following:\r\n* Unstable angina (e.g., anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment\r\n* Myocardial infarction within 6 months prior to initiating study treatment\r\n* Ventricular arrhythmias requiring anti-arrhythmic therapy other than beta blockers\r\n* New York Heart Association (NYHA) class III or IV congestive heart failure Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Active or clinically significant cardiac disease including any of the following:\r\n* Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment\r\n* Myocardial infarction within 6 months prior to initiating study treatment\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers\r\n* New York Heart Association (NYHA) class III or IV congestive heart failure Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months History or current condition of an uncontrolled cardiovascular disease including congestive heart failure NYHA > Class 2, unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months) or myocardial infarction within past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted). History or current evidence of uncontrolled cardiovascular disease including, but not limited to, the following conditions:\r\n* Congestive heart failure of New York Heart Association (NYHA) class III or IV\r\n* Unstable angina (symptoms of angina at rest) or new-onset angina =< 6 months before the start of anetumab ravtansine Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Active or clinically significant cardiac disease including any of the following:\r\n* Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment\r\n* Myocardial infarction within 6 months prior to initiating study treatment\r\n* Cardiac arrhythmias currently requiring anti-arrhythmic therapy other than beta blockers Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (angina symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Subjects who have a history or current evidence of uncontrolled cardiovascular disease including but not limited to the following conditions:\r\n* Congestive heart failure of New York Heart Association (NYHA) class III or IV\r\n* Unstable angina (symptoms of angina at rest) or new-onset angina within < 3 months before the start of study treatment\r\n* Arterial thrombosis, deep vein thrombosis, or pulmonary embolism within < 3 months before the start of study treatment\r\n* Myocardial infarction or stroke within < 3 months before the start of study treatment\r\n* Pericarditis (any CTCAE grade), pericardial effusion (CTCAE grade >= 2) or pleural effusion (CTCAE grade >= 2)\r\n* Cardiac arrhythmia requiring anti-arrhythmic therapy; subjects receiving digoxin, calcium channel blockers except verapamil, or beta-adrenergic blockers except propranolol are eligible at the investigator’s discretion if the dose has been stable for at least 2 weeks before the start of study treatment; subjects with sinus arrhythmia and infrequent premature ventricular contractions are eligible at the investigator’s discretion Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Active or clinically significant cardiac disease including:\r\n* Congestive heart failure - New York Heart Association (NYHA) > class II\r\n* Coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina or new-onset angina within 3 months before randomization, or myocardial infarction (MI) within 6 months before randomization Active or clinically significant cardiac disease including:\r\n* Congestive heart failure - New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Left ventricular function < 50%\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization\r\n* Patients who have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy\r\n* Patients who are receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin (maximum dose 325 mg/day) is permitted Active or clinically significant cardiac disease including: \r\n* Congestive heart failure - New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization. Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Active or clinically significant cardiac disease including: \r\n* Congestive heart failure - New York Heart Association (NYHA) > class II \r\n* Active coronary artery disease that is not medically treated\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before registration, or myocardial infarction within 6 months before registration Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class >II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months before study entry), myocardial infarction within the past 3 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted). Active or clinically significant cardiac disease including: \r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina < 3 months before randomization, or myocardial infarction within 6 months before randomization History of clinically significant cardiac disease or congestive heart failure > New York Heart Association (NYHA) class 2; patients must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months, or myocardial infarction within 6 months Active or clinically significant cardiac disease including:\r\n* Congestive heart failure - New York Heart Association (NYHA) > class II;\r\n* Active coronary artery disease that is not medically treated;\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization History of cardiac disease: congestive heart failure (CHF) > NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy History of cardiac disease: congestive heart failure (CHF) > NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Active or clinically significant cardiac disease including:\r\n* Congestive heart failure-New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before treatment, or myocardial infarction within 6 months before treatment Active cardiac disease including any of the following:\r\n* Congestive heart failure (New York Heart Association [NYHA]) >= class 2\r\n* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months); myocardial infarction less than 6 months before start of day 1 of irinotecan\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before study entry Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Corrected QT (QTc) > 500 ms\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Active cardiac disease including any of the following: \r\n* Congestive heart failure (New York Heart Association [NYHA]) >= class 2\r\n* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months); myocardial infarction less than 6 months before start of day 1 of FOLFIRI\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)\r\n* Uncontrolled hypertension; (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management) Has active or clinically significant cardiac disease including:\r\n* Congestive heart failure - New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before initiation, or myocardial infarction within 6 months before initiation Congestive heart failure > New York Heart Association (NYHA) class 2: unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before study registration; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted); uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management). History of clinically significant cardiac disease or congestive heart failure > New York Heart Association (NYHA) class 2. Subjects must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months. No uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris or new onset angina that began within the last 3 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy History of cardiac disease including congestive heart failure New York Heart Association (NYHA) Class >II (Section 14.7), unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (eg angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography) Active or clinically significant cardiac disease including:\r\n* Congestive heart failure-New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Uncontrolled cardiac arrhythmias despite optimal management\r\n* Unstable angina (anginal symptoms at rest), new-onset angina, myocardial infarction within 3 months of initiation of treatment on trial Have congestive heart failure classified as New York Heart Association Class 2 or higher.Have had unstable angina (angina symptoms at rest) or new-onset angina ? 3 months prior to screening. Have had a myocardial infarction < 6 months prior to initiation of study treatment. Serious illness including, significant ongoing or active infection, New York Heart Association (NYHA) grade III or IV congestive heart failure, unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within past 3 months; serious medical or psychiatric illness/social situations that in the opinion of the investigator would limit compliance with study requirements Congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class > II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months before study entry), myocardial infarction within the past 3 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted) Subject with uncontrolled cardiac disease including congestive heart failure class III or IV by the NYHA, unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months History of cardiac disease including congestive heart failure New York Heart Association (NYHA) Class >/=III, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months or cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. major regional wall motion abnormalities on baseline echocardiography or a left ventricular ejection fraction (LVEF) <45%) History of cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography) Patients must not have cardiac disease defined as: New York Heart Association (NYHA) > class II; patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before registration, or myocardial infarction within 6 months before registration Cardiac disease:\r\n* Congestive heart failure > class II New York Heart Association (NYHA), or\r\n* Unstable angina (anginal symptoms at rest), or new-onset angina (begun within the last 3 months), or myocardial infarction within the 6 months prior to enrollment, or \r\n* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\r\n* Congenital long QT syndrome or taking drugs known to prolong the QT interval\r\n* Subjects taking any drugs with a known risk of causing torsades de pointes Congestive heart failure > class II New York Heart Association (NYHA); unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Cardiac disease: Congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Cardiac disease: Congestive heart failure > class II New York Heart Association (NYHA): unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months, or uncontrolled arrhythmia History of cardiac disease congestive heart failure (CHF) > NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or Digoxin are permitted). Congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina pectoris (defined as anginal symptoms at rest, new-onset angina within 3 months before study treatment initiation, or myocardial infarction within 6 months before study treatment initiation), cardiac arrhythmia (which require anti-arrhythmic therapy other than beta blockers or digoxin), active coronary artery disease, or psychiatric illness/social situations that would limit compliance with study requirements Active or clinically significant cardiac disease including: a. congestive heart failure-New York Heart Association (NYHA) > class II; b. active coronary artery disease; c. cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin; d. unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization History of cardiac disease, including congestive heart failure of New York Heart Association (NYHA) class >II, unstable angina (anginal symptoms at rest) or new-onset angina (within 6 months prior to study entry), myocardial infarction within 6 months prior to study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography or multiple-gated acquisition [MUGA] scan). Patients with a pacemaker are also excluded Patients with a known history of congestive heart failure (CHF), cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications, or with a clinical history suggestive of the above must have an electrocardiography (EKG) and echocardiogram (ECHO) performed within 42 days prior to registration and as clinically indicated while on treatment Symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within 6 months of registration History of congestive heart failure or myocardial infarction <1 year prior to first study dose administration Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure Evidence or history of significant cardiac disease (such as, but not limited to, unstable angina pectoris, myocardial infarction within the prior 6 months, heart failure within 6 months, symptomatic congestive heart failure, symptomatic or uncontrolled arrhythmias, severe aortic stenosis, symptomatic mitral stenosis). History of active myocardial ischemia, cardiomyopathy, uncontrolled dysrhythmia, or congestive heart failure within the last 6 months before enrollment History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure within the last 6 months History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within the previous year. Uncontrolled hypertension, unstable angina, congestive heart failure of any NYHA classification stage greater than (>) 2, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment No unstable angina or myocardial infarction within the prior 6 months; no symptomatic congestive heart failure; no serious cardiac arrhythmia requiring medication; no cerebrovascular ischemia or stroke within the past 6 months History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months Presence of uncontrolled hypertension or congestive heart failure, or acute myocardial infarction within 6 months of entry COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Known history of cardiac arrhythmias including uncontrolled atrial fibrillation, tachyarrhythmias or bradycardia, history of congestive heart failure, or myocardial infarction or stroke in the previous 3 months will be excluded COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Known history of cardiac arrhythmias including uncontrolled atrial fibrillation, tachyarrhythmias or bradycardia, history of congestive heart failure, or myocardial infarction or stroke in the previous 3 months will be excluded COHORT 3: ENDOMETRIAL CANCER: Known history of cardiac arrhythmias including uncontrolled atrial fibrillation, tachyarrhythmias or bradycardia, history of congestive heart failure, or myocardial infarction or stroke in the previous 3 months will be excluded Research participants does NOT have any known history of congestive heart failure (CHF) or cardiac symptoms consistent with NYHA classification III-IV within 6 months prior to Day 1 of protocol treatment, cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications or with clinical history suggestive of the above must have an EKG and echocardiogram (ECHO) performed within 42 days prior to registration and as\r\nclinical indicated while on treatment Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within the previous 6 months History or presence of myocardial infarction, clinically relevant valvular heart disease, or congestive heart failure within the last 12 months; No uncontrolled angina, congestive heart failure or myocardial infarction (MI) within 6 months Patient has history of uncontrolled angina, congestive heart failure or recent myocardial infarction (MI) within 6 months Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months Myocardial infarction (MI) < 6 months, congestive heart failure (CHF), unstable angina, active cardiomyopathy, unstable ventricular arrhythmia Severe co-morbidity that would confer excess risk of surgery, radiation or chemotherapy, defined as follows:\r\n* Unstable angina and/or congestive heart failure within the last 6 months\r\n* Transmural myocardial infarction within the last 6 months\r\n* Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiography (EKG) performed within 14 days of registration\r\n* New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration\r\n* History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months\r\n* Serious and inadequately controlled cardiac arrhythmia Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude administration of study drugs; patients with uncontrolled congestive heart failure, unstable angina and myocardial infarction within 3 months will be excluded Patients with uncontrolled cardiovascular disease (a history of hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within 3 months prior to registration) will be excluded No uncontrolled angina, congestive heart failure or myocardial infraction (MI) within 6 months prior to registration on study Cardiovascular disease: history of congestive heart failure, myocardial infarction within the 6 months of study entry, symptomatic cardiac arrhythmia requiring treatment Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months Unstable angina and/or symptomatic congestive heart failure requiring hospitalization within the last 6 months; transmural myocardial infarction within the last 6 months prior to study entry Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Patients with class III or greater congestive heart failure (CHF) or myocardial infarction (MI) within last 6 months Have serious medical illnesses including, but not limited to, congestive heart failure, myocardial infarction or cerebral vascular accident within the last six months, or life threatening cardiac arrhythmias. uncontrolled or severe cardiovascular disease, including recent (<6 months) myocardial infarction or congestive heart failure, Medical illness unrelated to MCL within the prior one month that will preclude administration of chemotherapy safely; this includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, active congestive heart failure, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis Symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within 6 months of enrollment Unstable angina and/or congestive heart failure requiring hospitalization within 3 months prior to step 1 registration Serious comorbidities (as determined by the investigator) such as, but not limited\n to, active congestive heart failure or recent myocardial infarction. Patients who\n require antifolate therapy for the management of comorbid conditions (e.g.,\n rheumatoid arthritis) will be excluded from the trial. Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months Subjects with a history of class III or IV congestive heart failure or non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 6 months history within the last 6 months of symptomatic congestive heart failure, myocardial infarction, or unstable angina Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia Has evidence of active heart disease such as myocardial infarction within the 3 months prior to study entry; symptomatic coronary insufficiency congestive heart failure; moderate or severe pulmonary dysfunction Myocardial infarction, symptomatic congestive heart failure, unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months History of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure, within the 6 months prior to study drug administration Unstable medical conditions (eg, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH) Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Patients with clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker History or presence of angina, myocardial infarction, clinically relevant valvular heart disease, uncontrolled hypertension, or congestive heart failure within the previous 12 months. Unstable medical conditions (eg, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH). A history of congestive heart failure, transmural myocardial infarction, symptomatic valvular disease, or high-risk arrhythmia Unstable angina and/or congestive heart failure in the last 6 months, transmural myocardial infarction within the last 6 months, New York Heart Association grade II or higher congestive heart failure requiring hospitalization within 12 months prior to registration, evidence of recent (within 14 days of registration) myocardial infarction by electrocardiogram (EKG) (only required if clinically indicated), serious or inadequately controlled cardiac arrhythmia, significant vascular and peripheral vascular disease, evidence of bleeding diathesis or coagulopathy Patient with unstable cardiac status including: 4.1. Unstable angina pectoris on medication 4.2. Documented myocardial infarction within 40 days prior to enrolment 4.3. Congestive heart failure NYHA class IV 4.4. Unstable arrhythmia status, already on anti-arrhythmic drugs Patients with active or history of cardiac (congestive heart failure [CHF], myocardial infarction, myocarditis) disease are excluded from this trial The participant has symptomatic congestive heart failure (CHF), left ventricular dysfunction (LVEF < 50%), severe myocardial insufficiency, cardiac arrhythmia, or cardiomyopathy. History of prior unstable angina, myocardial infarction, congestive heart failure (CHF), uncontrolled ventricular arrhythmias within 12 months Any of the following cardiac conditions: Documented congestive heart failure; Myocardial infarction within 6 months prior to study entry; Unstable angina within 6 months prior to study entry; Symptomatic arrhythmia History of congestive heart failure or myocardial infarction within the previous six months Recent (=< 6 months) myocardial infarction, unstable angina, difficult-to-control congestive heart failure, uncontrolled hypertension on appropriate therapy, or difficult to control cardiac arrhythmias Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias within the last six months. Patients must not have unstable angina or NYHA classification of congestive heart failure of grade >= 2 Presence of uncontrolled hypertension or congestive heart failure, or acute myocardial infarction within 6 months of entry History of acute myocardial infarction, unstable angina, congestive heart failure, or arrhythmia within the last three months Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within (6 months) Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias within the last six months. Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction Patients with unstable cardiac status including:\r\n* Unstable angina pectoris on medication\r\n* Patients with documented myocardial infarction within six months of protocol entry\r\n* Congestive heart failure requiring medication (other than diuretic)\r\n* Patients on anti-arrhythmic drugs Patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure (CHF) or recent myocardial infarction (within 6 months of enrollment) Life threatening illness (e.g., congestive heart failure, uncontrolled angina or myocardial infarction in the prior six months) Cardiopulmonary function criteria:\r\n* Current unstable arrhythmia requiring treatment\r\n* History of symptomatic congestive heart failure\r\n* History of myocardial infarction within 6 months of enrollment\r\n* Current unstable angina\r\n* Family history of long QT syndrome Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months. The patient has had congestive heart failure, unstable angina, a myocardial infarction, cardiac conduction abnormality or pacemaker or a stroke within 3 months of entering the study. PART I: Co-morbid condition that would affect survival: end stage congestive heart failure, unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood sugars >= 300 mg/dL, participants with known chronic active hepatitis or cirrhosis PART II: Co-morbid condition that would affect survival: end stage congestive heart failure, unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood sugars >= 300mg/dL, participants with known chronic active hepatitis or cirrhosis Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months. Uncontrolled hypertension, arrhythmia, congestive heart failure or angina; patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms The patient has a history of congestive heart failure, cor-onary artery disease or previous myocardial infarction. Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment Electrocardiogram, showing no indications of cardiac problems like congestive heart failure, myocardial infarction, and cardiomyopathy Have a known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration. Transmural myocardial infarction, unstable angina, or congestive heart failure requiring hospitalization within the last 6 months No pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program (e.g., severe orthopedic conditions, scheduled surgery within 6 months, paralysis and/or dementia, unstable angina, history of myocardial infarction, congestive heart failure) as assessed through oncologist approval Any condition that, in the opinion of the investigator, may interfere with the objectives of the study, e.g., any condition requiring the use of prohibited drugs or unstable medical conditions other than AML/MDS, such as a cardiac or neurologic disorder expected to be unstable or progressive during the course of the study (e.g., seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia or unstable congestive heart failure, unstable arrhythmias) Patients with unstable cardiac status including: 4.1 Unstable angina pectoris on medication 4.2 Patients with documented myocardial infarction within 40 days prior to enrollment 4.3 Congestive heart failure NYHA class IV 4.4 Patients with unstable arrhythmia status, already on anti-arrhythmic drugs Patients with a history of hypercalcemia or vitamin D toxicity, or hospitalization for treatment of angina, myocardial infarction, or congestive heart failure or psychiatric illness currently or within 30 days of study entry as determined by the investigator. Unstable cardiac disease, e.g., unstable angina, congestive heart failure or myocardial infarction within the preceding 6 months History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year. Significant ischemic coronary disease, heart failure, myocardial infarction, or unstable angina within the last six months. Has a history of Class II-IV congestive heart failure or myocardial infarction within 6 months of randomization. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months