Evidence of a significant uncontrolled concomitant disease of the nervous system, pulmonary, autoimmune, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture
Evidence or history of other significant, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which would likely increase the risks of participating in the study.
Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or central nervous system disorders.
Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
Patients with a known history of drug abuse or any chronic neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic or renal disease (including a history of hemolytic uremic syndrome) that in the opinion of the Investigator would adversely affect study participation.
Adequate organ function: Patients should have adequate hepatic, renal, cardiac and pulmonary function to undergo reduced intensity HCT based upon local institutional guidelines, or at a minimum meet requirements noted in eligibility checklist Appendix A-VIII_1. However, significant hepatic and pulmonary dysfunction, if secondary to underlying LCH disease activity, will not exclude patients from protocol enrollment and should be discussed with the National PI Coordinator and the Coordinating Principal Investigator.
Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular or hepatic disease, within the last 6 months that, in the opinion of the investigator, would adversely affect his/her participation in the study.
Patient has significant and/or uncontrolled cardiac, renal, hepatic or other systemic disorders or significant psychological conditions at baseline visit that in the investigator’s judgment would jeopardize subject enrollment or compliance with the study procedures
Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:\r\n* New York Heart Association heart failure > class 2\r\n* Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia
Participant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of azacitidine that in the opinion of the investigator would adversely affect his/her participating in this study.
Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, electrocardiography (EKG), and/or laboratory screening test
Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, hepatic renal, and/or other functional abnormality that would jeopardize the health and safety of the participant as determined by the investigator based on medical history, physical examination, laboratory values, and/or diagnostic studies
Participant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of LDAC that in the opinion of the investigator would adversely affect his/her participating in this study.
Major medical conditions that might affect study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled serious infection, cardiac disease)
The subject has a history of advanced cardiac, hepatic or renal disease or other chronic illness
History of renal or hepatic disease, including history of hepatitis B or C
Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, electrocardiogram (EKG), and/or laboratory screening test
Patients with renal, hepatic, pulmonary, or cardiac disease that exclude delivery of standard chemotherapy
Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participating in the study.
Significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or autoimmune conditions that in the opinion of the investigator places the subject at an unacceptable risk as participant in this trial
Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, electrocardiogram (EKG), and/or laboratory screening test
Subjects must not have a history of any significant renal or hepatic disease requiring ongoing medical therapy or clinical intervention
No overt renal, hepatic, cardiac or pulmonary disease
A serious, unstable illness, as judged by the Investigator, during the past 3 months before screening/baseline visit including but not limited to: hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic or immunologic disease;
Has significant renal or hepatic disease, uncontrolled or severe cardiovascular or pulmonary diseases, or other uncontrolled medical condition that, based on the Investigator's assessment, would compromise the patient's ability to tolerate study treatment or the assessment of treatment response.
Patients with significant concurrent, uncontrolled medical condition including, but not limited to, cardiovascular, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient, are NOT eligible
Evidence of current serious uncontrolled concomitant cardiovascular nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease
Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease
No overt renal, hepatic, cardiac or pulmonary disease
Evidence of clinically significant disease (e.g., cardiovascular, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.
History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.
History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.
Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
No active autoimmune disease or uncontrolled infection, normal bone marrow, renal, hepatic function, FEV1 > 1.2L, no significant underlying heart or lung disease
Participant has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study.
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the participant
A history of significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular or hepatic disease
Evidence of clinically significant disease (e.g., cardiovascular, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator could affect the subject safety or interfere with the study assessments
Evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which would likely increase the risks of participating in the study. The specific type of stress test will be selected at the PI's discretion.
Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease, that in the opinion of the investigator, would adversely affect his/her participation in the study.
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient
History of significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
Systemic diseases (cardiovascular, renal, hepatic, etc) that would prevent study treatment in the investigator's opinion.
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient\r\n* Those patients with medical conditions that are controlled with medical therapy are eligible
Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the option of the investigator may represent a risk for the patient
Subject has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.
Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs.
History or clinical evidence of any surgical or medical condition which the investigator judges as likely to interfere with the results of the study or pose an additional risk in participating (eg, active or clinically significant history of disease involving a major organ system—vascular, cardiac, pulmonary, hepatic, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine or immunodeficiency, autoimmune or clinically significant active psychiatric disorders)
Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision
Systemic disease that would prevent study treatment (uncontrolled hypertension, cardiovascular renal, hepatic (including Child-Pugh Class B and C) or metabolic disease)
The donor currently has or had a history of any clinically relevant gastrointestinal, hematologic, respiratory, psychiatric, renal, hepatic, cardiac, metabolic (eg, fructose intolerance), neurological, or any other disease or condition which may influence the physiological metabolic turnover (eg, severe endocrine diseases, febrile condition, severe infections
Significant disease or uncontrolled disease, i.e. cardiovascular renal, hepatic, endocrine, metabolic, neurologic; or other significant disease that would limit the patients ability to participate in the study as determined by the investigator or medical monitor.
Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
Uncontrolled concomitant medical conditions, including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases.
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient
Evidence of significant uncontrolled concomitant diseases, such as ocular toxicities, diabetes, cardiovascular disease; nervous system, renal, hepatic, endocrine, or gastrointestinal disorders; autoimmune disease, or a serious non-healing wound or fracture
Clinical or laboratory signs and symptoms of significant cerebral, cardiovascular, respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the Investigator's judgment may interfere with the study assessment or completion of the study.
Clinically significant pulmonary, endocrine, neurologic, hematologic, gastrointestinal (GI), autoimmune, psychiatric or genitourinary disease unrelated to HCC that in the judgment of the investigator should preclude treatment with dalantercept or sorafenib.
Subject has a significant history of cardiovascular disease (e.g., myocardial infarction [MI], thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study
Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or central nervous system disorders
Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture
Other significant concurrent, uncontrolled medical conditions including, but not limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which, in the Investigator's opinion, will impact study participation.
Other significant concurrent, uncontrolled medical conditions including, but not limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which, in the investigator's opinion, will impact study participation.
No unstable neurologic, hepatic, renal, cardiovascular, lymphatic, or metabolic disease
Has a clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or pulmonary disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator.
Evidence of clinically significant disease (e.g., cardiovascular, respiratory, gastrointestinal, renal, or infectious disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
Medical conditions felt to be clinically contributing to fatigue based on the investigator’s history, physical examination, and assessment: anemia (hemoglobin less than 10 g/dl), hypothyroidism (thyroid stimulating hormone greater than 4.6 MCU/mL), uncontrolled pain, medical problems associated with fatigue: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson’s disease, and poorly controlled sleep apnea
History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder that, in the opinion of the investigator, contraindicates participation.
Medical conditions felt to be clinically contributing to fatigue based on the investigator’s history, physical examination, and assessment: anemia (hemoglobin less than 10 g/dl), hypothyroidism (thyroid stimulating hormone greater than 4.6 MCU/mL), uncontrolled pain, medical problems associated with fatigue: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson’s disease, and poorly controlled sleep apnea
Pulmonary disease, renal dysfunction, hepatic disease, cardiac disease, neurologic disease;
Any significant cardiac, hepatic or renal disease
Evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, dermatologic, immune disorder, or other disease that may interfere with assessment of safety or efficacy of vaccine activity as indicated in study objectives
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.
History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other diseases, which, in the opinion of the investigator, may affect the subject's safety or interfere with the trial.
Severe or uncontrolled/unstable cardiac, pulmonary, hepatic or renal disease, including MI or CVA within 3 months prior to treatment.
Clinically significant or uncontrolled cardiac disease.
Serious co-morbid medical conditions, including clinically-significant cardiac disease
History of clinically significant cardiac dysfunction
Clinically significant cardiac disease.
History of clinically significant cardiac dysfunction
History of clinically significant cardiac disease; uncontrolled hypertension
Clinically significant cardiac disease
History of clinically significant cardiac or pulmonary dysfunction as specified in antecedent study
History of clinically significant cardiac dysfunction
History of autoimmune disease, clinically significant cardiac or pulmonary dysfunction
Clinically significant cardiac disease.
Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months prior to randomization)
Active or clinically significant cardiac disease.
History of clinically significant or uncontrolled cardiac disease including but not limited to:
History of clinically significant cardiac dysfunction
Patients must not have clinically significant cardiac disease.
Clinically significant cardiac disease
Documented clinically significant cardiac arrhythmias
Have a significant cardiac condition.
Active or clinically significant cardiac disease
clinically significant cardiac disease
Subjects with clinically significant uncontrolled cardiac disease
Clinically significant cardiac disease
History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease
Clinically significant or uncontrolled cardiac disease.
Clinically significant cardiac disease
History of clinically significant cardiac disease
Clinically significant cardiac disease as per protocol-defined criteria.
Have clinically significant cardiac disease
Sustained or clinically significant cardiac arrhythmias
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or clinically significant cardiac arrhythmias
Significant history or risk of cardiac disease
Has clinically significant cardiac disease
History of clinically significant or uncontrolled cardiac, hepatic, or pulmonary disease
Significant active cardiac disease within the previous 6 months
Has clinically significant cardiac disease
Clinically significant cardiac disease
Clinically significant cardiac disease
Clinically significant cardiac or pulmonary dysfunction
Significant active cardiac disease within the previous 6 months, including:
Clinically significant, uncontrolled heart disease and/or recent cardiac repolarization abnormality including any of the following:
Clinically significant active cardiac disease, uncontrolled heart disease and/or history of cardiac dysfunction including any of the following
Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months); any history of clinically significant cardiac failure
Active or clinically significant cardiac disease including:
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
Uncontrolled or significant cardiac disease
Clinically significant or uncontrolled hypertension or cardiac disease
Have clinically significant cardiac disease
History of clinically significant cardiac or pulmonary dysfunction
Clinically significant, uncontrolled heart disease and/or recent cardiac event within 6 months prior to study
No clinically significant cardiac conduction disorder on screening.
History of clinically significant or uncontrolled cardiac disease.
Significant cardiac impairment
Significant cardiac disease within 6 months
Clinically significant cardiac disease as defined in the protocol
Clinically significant cardiac disease
Significant cardiac disease
Evidence or history of significant cardiac disease
Clinically significant cardiac disease
Significant cardiac events
History of clinically significant cardiac disease
Clinically significant, uncontrolled heart disease and/or recent cardiac events.
Clinically significant cardiac disease
History of clinically significant cardiac dysfunction
Clinically significant cardiac disease, including:
Have clinically significant cardiac disease
Clinically significant cardiac disease
Uncontrolled systemic disease (e.g., clinically significant cardiac, pulmonary or metabolic disease)
Significant history of cardiac disease
History of clinically significant cardiac disease.
Significant history of cardiac disease
Clinically significant cardiac disease;
Clinically significant cardiac or pulmonary dysfunction
Significant active cardiac disease within the previous 6 months:
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or clinically significant cardiac arrhythmias
History of clinically significant cardiac or pulmonary dysfunction
Sustained or clinically significant cardiac arrhythmias
Any clinically significant comorbidities, such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease (specified below), active CNS disease, active infection, or any other condition that could compromise the participant's participation in the study.
Clinically significant cardiac disease
Subjects with clinically significant uncontrolled cardiac disease
Clinically significant cardiac or pulmonary disease
Significant active cardiac disease within the previous 6 months, including:
History of clinically significant or uncontrolled cardiac disease.
Clinically significant cardiac disease within last 12 months
History of clinically significant or active cardiac disease
Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months
History of clinically significant cardiac dysfunction
Patients with clinically relevant medical history, including autoimmune disease, cardiovascular disease, hepatic disease or bleeding disorders
Subjects with clinically significant cardiovascular disease, including:
Significant active cardiovascular or pulmonary disease including:
Current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular, pulmonary, or renal disease) other than cancer
Significant active cardiovascular or pulmonary disease before administration of the first dose of study drug, including:
Patients with a significant cardiovascular disease or condition, including:
Patients with a significant cardiovascular disease or condition, including:
Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
Clinically significant cardiovascular disease including:
Have significant, uncontrolled, or active cardiovascular disease, including, but not restricted to:
Subject has significant cardiovascular disease, including:
Significant cardiovascular disease including Congestive Heart Failure or poorly controlled hypertension.
Impaired cardiovascular function or clinically significant cardiovascular disease including any of the following: symptomatic congestive heart failure, clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening except for atrial fibrillation and paroxysmal supraventricular tachycardia
Significant cardiovascular disease (including congestive heart failure).
Significant active cardiovascular or pulmonary disease including:
Subject has clinically significant cardiovascular disease including:
Patient has uncontrolled or significant cardiovascular disease, including:
Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
Uncontrolled or significant cardiovascular disease, including:
History of clinically significant cardiovascular disease including.
Significant cardiovascular disease including CHF, leptomeningeal disease, poorly controlled hypertension, or an MI within 6 months prior to dosing.
History of clinically significant cardiovascular disease including:
Clinically significant cardiovascular disease at screening including:
Significant cardiovascular disease including CHF or poorly controlled hypertension.
Significant cardiovascular disease including CHF or poorly controlled hypertension.
Uncontrolled or significant cardiovascular disease, including:
Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following: symptomatic chronic heart failure; evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia
Patients with a significant cardiovascular disease or condition, including:
Patients with a significant cardiovascular disease or condition, including:
Clinically significant cardiovascular disease including:
Current severe, uncontrolled systemic disease (including but not limited to clinically significant cardiovascular, pulmonary, or renal disease or ongoing or active infection) excluding the cancer under study
Patient has uncontrolled or significant cardiovascular disease, including:
Patients with malnutrition, active infection, significant pulmonary disease and cardiovascular disease as determined by the physician as they could impact fatigue
Uncontrolled or significant cardiovascular disease, including any of the following:
Significant cardiovascular disease including CHF or poorly controlled hypertension.
Clinically significant cardiovascular disease including:
Significant history of cardiovascular disease
Uncontrolled or significant cardiovascular disease
Evidence of clinically significant cardiovascular and respiratory conditions
Significant cardiovascular disease;
Significant cardiovascular disease or active pulmonary disease
Clinically significant cardiovascular disease
Significant cardiovascular disease
Significant cardiovascular disease
Significant cardiovascular/cerebrovascular disease within 6 months prior to Day 1 of study drug administration
Significant cardiovascular disease
Current severe, uncontrolled systemic disease (for example [e.g.] clinically significant cardiovascular, pulmonary, or metabolic disease)
Significant cardiovascular disease.
Clinically significant cardiovascular disease
Significant cardiovascular disease
Any significant cardiovascular events within 6 months prior to study entry
History of a significant cardiovascular illness
Significant cardiovascular disease
Uncontrolled or significant cardiovascular diseases
Uncontrolled or significant cardiovascular disease
Subjects with significant or uncontrolled cardiovascular disease
Significant cardiovascular disease
Clinically significant cardiovascular disease or condition
Patients with clinically significant cardiovascular disease, thromboembolic disease, or significant risk of bleeding.
Uncontrolled or significant cardiovascular disease
Significant cardiovascular disease or ECG abnormalities.
Currently active clinically significant cardiovascular disease or history of myocardial infarction within 6 months of first dose
Clinically significant cardiovascular or pulmonary disease
Significant known cardiovascular impairment.
Uncontrolled or significant cardiovascular disease.
History of clinically significant cardiovascular disease
Clinically significant cardiovascular disease.
Clinically significant cardiovascular disease or condition
Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
History of clinically significant cardiovascular disease;
Uncontrolled or significant cardiovascular disease
Clinically significant cardiovascular disease.
Clinically significant cardiovascular disease
Uncontrolled or significant cardiovascular disease
Clinically significant cardiovascular disease.
Clinically significant cardiovascular disease
Cardiovascular Function: Adequate cardiovascular function in the opinion of the Investigator with no clinically significant uncontrolled cardiovascular disease.
Clinically significant cardiovascular disease or condition
Significant cardiovascular disease, such as
Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1
Subjects who developed cardiovascular disease within 24 weeks prior to study entry, which is deemed to be clinically significant by the Investigator.
Has uncontrolled or significant cardiovascular disease
Known clinically significant cardiovascular disease or condition.
Have a significant electrocardiogram finding or cardiovascular disease
Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 6 months prior to inclusion
Clinically significant, uncontrolled, cardiovascular disease.
History of clinically-significant cardiovascular disease.
Significant cardiovascular disease
Uncontrolled or significant cardiovascular disease
Significant cardiovascular disease
Clinically significant cardiovascular disease
Clinically significant cardiovascular risk.
Uncontrolled or significant cardiovascular disease
Clinically significant (i.e., active) cardiovascular disease
Significant cardiovascular disease.
Significant cardiovascular disease within 6 months of screening.
Significant cardiovascular disease within 6 months of screening.
Significant cardiovascular disease
Uncontrolled or significant cardiovascular disease
Significant cardiovascular disease
Uncontrolled or significant cardiovascular disease
Significant cardiovascular disease.
Significant cardiovascular disease
Clinically significant cardiovascular disease
Subject has clinically significant cardiovascular disease.
Clinically significant cardiovascular disease;
Clinically symptomatic and uncontrolled cardiovascular disease
Significant cardiovascular disease
Have significant, uncontrolled, or active cardiovascular disease, as defined by the study protocol.
Patients with clinically significant cardiovascular disease.
History of autoimmune disease, significant pulmonary disease, or significant cardiovascular disease
Significant cardiovascular or liver disease
Significant history of cardiovascular disease
Patients with clinically significant, uncontrolled cardiovascular disease
Significant cardiovascular disease or significant pulmonary disease
Significant cardiovascular diseases
Significant cardiovascular or pulmonary disease
Subjects with clinically significant cardiovascular disease.
Subjects with clinically significant cardiovascular disease. This includes:
Significant cardiovascular disease
Currently active, clinically significant cardiovascular disease.
Currently active, clinically significant cardiovascular disease
Significant cardiovascular disease.
Significant cardiovascular disease
Clinically significant cardiovascular disease;
Clinically significant cardiovascular disease
Significant cardiovascular disease
Clinically significant cardiovascular disease
Uncontrolled or significant cardiovascular disease
Clinically significant (that is, active) cardiovascular disease
Impaired cardiovascular function or clinically significant cardiovascular diseases
Impaired cardiovascular function or clinically significant cardiovascular diseases.
Impaired cardiovascular function or clinically significant cardiovascular diseases
Have significant or active cardiovascular disease
Currently active, clinically significant cardiovascular disease
Active cardiovascular disease or significant history thereof.
Significant cardiovascular disease.
Clinically significant cardiovascular disease;
DONOR: Significant cardiovascular disease
Uncontrolled or significant cardiovascular disease
History (within the last 6 months) of significant cardiovascular disease.
Significant or uncontrolled cardiovascular disease
Significant cardiovascular disease
Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
History of significant cardiovascular disease, defined as:
Clinically significant cardiovascular disease.
Significant cardiovascular disease
History of significant cardiovascular disease will be excluded
Currently active, clinically significant cardiovascular disease or myocardial infarction within 6 months of screening
Significant history of cardiovascular disease
Clinically significant cardiovascular impairment
Significant cardiovascular disease
Subject has a significant cardiovascular disease
Significant cardiovascular diseases
Clinically significant cardiovascular risk
Clinically significant cardiovascular disease
Significant or uncontrolled cardiovascular disease or bleeding disorder
Uncontrolled or significant cardiovascular disease
Uncontrolled or significant cardiovascular disease
Uncontrolled hypertension or clinically significant cardiovascular disease
Significant cardiovascular impairment, defined as:
Impaired cardiovascular function or clinically significant cardiovascular diseases
Uncontrolled or significant cardiovascular disease
History of clinically-significant cardiovascular disease
Significant history of cardiovascular disease
History of clinically significant cardiovascular disease, gastrointestinal disorder, or significant pulmonary compromise.
Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are ineligible
Significant cardiovascular disease
History of clinically significant cardiovascular disease
Uncontrolled or significant cardiovascular disease
Clinically significant cardiac/cardiovascular disease, or pulmonary compromise
Currently active clinically significant cardiovascular disease or history of myocardial infarction within 6 months of first dose
Any uncontrolled medical condition (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment or confound interpretation of study assessments.
Research participants with any concomitant significant medical illness that in the investigator’s opinion cannot be adequately controlled with appropriate therapy, or that would impair the evaluation of side effects related to this treatment, alter drug metabolism or the tolerance to this treatment
Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment
Clinically relevant diseases (for example, inflammatory bowel disease) and /or uncontrolled medical conditions, which, in the opinion of the investigator, might impair the subject’s tolerance or ability to participate in the trial.
Clinically relevant diseases (for example, inflammatory bowel disease) and/or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject’s tolerance or ability to participate in the trial
Clinically relevant diseases (for example, inflammatory bowel disease) and / or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject’s tolerance or ability to participate in the trial.
All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatment
Any significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatment
All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatment
Any significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatment
All other significant diseases, which in the opinion of the investigator, may impair the subject’s tolerance of trial treatment
Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment
All other significant diseases might impair the subject's tolerance of trial treatment
All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment
All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment
All other significant diseases (e.g., inflammatory bowel disease) that, in the opinion of the investigator, might impair the subject's tolerance of trial treatment.
Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
Any significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatment
All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatment
Impaired cardiac function or clinically significant cardiac disease.
Impaired cardiac function or clinically significant cardiac disease
Impaired cardiac function or clinically significant cardiac disease, including any of the following (Criteria a through g):
Impaired cardiac function or clinically significant cardiac disease.
Impaired cardiac function or clinically significant cardiac disease
Subject has any neuropathy > Grade 1. 5. Subject has impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Clinically significant cardiac disease or impaired cardiac function
Impaired cardiac function or clinically significant cardiac disease.
Impaired cardiac function or clinically significant cardiac disease.
Impaired cardiac function or clinically significant cardiac diseases
Participants with impaired cardiac function or clinically significant cardiac disease.
Clinically significant cardiac disease or impaired cardiac function, including any of the following:
Patients who have impaired cardiac function or clinically significant cardiac diseases,
Impaired cardiac function or clinically significant cardiac disease
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* Acute myocardial infarction or angina pectoris =< 6 months prior to starting study drug
Impaired cardiac function or clinically significant cardiac disease
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Impaired cardiac function or clinically significant cardiac disease
Patients with impaired cardiac function or clinically significant cardiac disease.
Impaired cardiac function or clinically significant cardiac diseases.
Clinically significant cardiac disease or impaired cardiac function, including any of the following:
Patients with impaired cardiac function or clinically significant cardiac diseases as defined by the protocol
Patients with impaired cardiac function or clinically significant cardiac disease:
Known impaired cardiac function or clinically significant cardiac disease
Impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or clinically significant cardiac disease
Clinically significant cardiac disease or impaired cardiac function
Patients must not have known impaired cardiac function or clinically significant cardiac disease
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Impaired cardiac function or clinically significant cardiac diseases.
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Clinically significant cardiac disease or impaired cardiac function
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Impaired cardiac function or clinically significant cardiac diseases
Impaired cardiac function or clinically significant cardiac diseases
Impaired cardiac function or clinically significant cardiac diseases
Impaired cardiac function or clinically significant cardiac disease
N2 or N3 disease detected clinically or by imaging
Has a medical history of clinically significant lung disease
Significant myelofibrosis (>2+fibrosis)
Clinically significant anemia due to non-MDS etiologies
Current diagnosis of any other active or clinically significant nonbreast cancer
Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to randomization that may prevent blood clotting and, in the investigator's opinion, could place the subject at risk.
Clinically significant third-space fluid accumulation
Evidence of increased intracranial pressure (clinically significant papilledema, vomiting, and nausea, or reduced level of consciousness)
Clinically significant neurologic event (stroke) or any neurological deficit lasting > 24 hours;
Have any clinically significant disease considered by the investigator to interfere with study participation
Has clinically significant heart disease that affects normal activities.
Evidence of clinically significant immunosuppression.
History of malabsorption or other clinically significant metabolic dysfunction
Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could interfere with per-protocol evaluations.
Known clinically important respiratory impairment
Any known clinically significant prior radiation to the chest area that included lung parenchyma.
Clinically significant surgical intervention within 21 days of the first dose of the IMP or with ongoing post-operative complications if more than 21 days.
Women who have had an abnormal gynecology exam within the last three years with clinically significant findings, such as secondary dysmenorrhea, polyps, or atypia, which in the opinion of the Investigator would interfere with the study.
EXCLUSION - TREATMENT: Clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, Adv, BK-virus, or HHV-6
Clinically significant anemia, neutropenia or thrombocytopenia at screening
Clinically significant cardiovascular disease, history of myocardial infarction within the last 6 months, or evidence of QTc interval prolongation at screening
History of malabsorption or other clinically significant metabolic dysfunction
Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers) as assessed by the principal investigator during screening and during the study
Patients with acute or chronic hepatic dysfunction as evidenced by clinically significant abnormalities in albumin, total protein, or prothrombin time, or evidence of hepatic injury with clinically important (> grade 1) changes in AST, ALT, ALP, bilirubin, or GGT values.
Must have a normal ejection fraction (within the reference range of the institution) and no clinically significant valvular dysfunction.
Evidence of increased intracranial pressure (clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
Clinically significant, uncontrolled heart disease
Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness)
Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema)
Ongoing clinically significant infection at or near the incident lesion
Participants with a history of clinically significant, uncontrolled heart disease and/or repolarization abnormalities
History of significant cerebrovascular disease
Has clinically significant lung disease or is suspected to have such diseases by imaging at Screening
Has clinically significant corneal disease
Treatment with clinically significant metabolic inducers within 14 days before the first dose of study drug; clinically significant metabolic inducers are not permitted during the study
Clinically significant abnormal laboratory results
Current, serious, clinically significant cardiac arrhythmias as determined by the investigator, or patient receiving a digitalis derivative.
Treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug; clinically significant metabolic enzyme inducers are not permitted during this study
Any clinically significant uncontrolled concomitant disease
Has any other clinically significant abnormal laboratory value in the opinion of the investigator
clinically significant CNS disorder
Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible
Clinically significant dry eye or contact lens use
Patients with any clinically significant autoimmune disease uncontrolled with treatment
Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
Active or clinically significant Gastric Antral Vascular Ectasia (GAVE, \watermelon stomach\)
Treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug; clinically significant metabolic enzyme inducers are not permitted during this study (CYP3A4/5 inducers)
Other serious illnesses or medical conditions including but not limited to:\r\n* Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry\r\n* History of significant neurologic or psychiatric disorders including dementia or seizures\r\n* Active clinically significant uncontrolled infection\r\n* Active peptic ulcer disease defined as unhealed or clinically active\r\n* Hypercalcemia\r\n* Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis\r\n* Chronic obstructive pulmonary disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis; this does not include obstruction from tumor\r\n* Autoimmune disease requiring therapy, prior organ transplant, or human immunodeficiency virus (HIV) infection\r\n* Interstitial lung disease\r\n* Hepatitis C by history, and confirmed by serology
History of clinically significant auditory or ocular toxicity with ICT
Another cancer that is not clinically stable
Complete metabolic profile (CMP) - no clinically significant findings
Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
Clinically significant, uncontrolled heart diseases.
Subject has a clinically significant peripheral artery disease, e.g., those with claudication, within 6 months
Patients with clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
Patients with any clinically significant autoimmune disease uncontrolled with treatment
Research participants without clinically significant encephalopathy/new focal deficits
Clinically significant heart disease
Clinically significant comorbid disease or other underlying condition, including major autoimmune disorders that would contraindicate study therapy or confuse interpretation of study results
Clinically significant comorbid disease or other underlying condition, including major autoimmune disorders that would contraindicate study therapy or confuse interpretation of study results
Treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug; clinically significant metabolic enzyme inducers are not permitted during this study
Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment
Has clinically significant corneal disease
Clinically significant, uncontrolled heart diseases
Clinically significant abnormality on ophthalmologic examination during screening evaluation
Clinically significant, uncontrolled heart diseases.
Evidence of clinically significant pancreatitis as determined by the investigator
Any significant ophthalmologic abnormality
Have significant baseline neuropathies
Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
Significant medical disease other than cancer
Significant medical disease other than cancer
Patients with significant intercurrent illnesses.
Any significant diseases (other than HL) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the subject from participating in the study
Clinically significant systemic disease, as determined by the investigator, which could affect study participation or study results
Clinically significant surgery within 2 weeks of enrollment.
Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
Presence of clinically significant increased intracranial pressure (e.g. impending herniation) or hemorrhage, uncontrolled seizures, or requirement for immediate palliative treatment.
Known, clinically significant carotid artery disease
Uncontrolled and clinically significant disease-related metabolic disorder
Patients must not have clinically significant autoimmune disease that requires treatment with immunosuppressant medications
Subjects with a history of significant hemoptysis per the treating physician's judgment, cerebral hemorrhage or clinically significant gastrointestinal (GI) hemorrhage or myocardial infarction (MI) within the past 6 months
Treatment for clinically-significant hyperglycemia, hyperlipidemia, or hypertension that develops on study is required
Clinically significant and unexplained elevated liver or renal function tests
Patients with abnormal serum chemistry values, which in the opinion of the Investigator is considered to be clinically significant, will be excluded from the study
Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
Clinically localized disease (?T2a) and
Significant immunosuppression.
Significant immunosuppression from:
Clinically significant third-space fluid accumulation
Has a medical history of clinically significant lung disease
Clinically significant heart disease
Significant immunosuppression from:
Has all prior treatment (i.e., chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ? Grade 1 per NCI CTCAE, Version 4.03 or are clinically stable and not clinically significant, at time of consent
significant fatigue
Clinically quantifiable disease burden defined as at least one of the following:
No clinically significant progression outside of the CNS on most recent EGFR inhibitor therapy
Patients who have received treatment with clinically significant enzyme inducers within 14 days prior to registration are not eligible
Significant immunosuppression from:
Has all prior treatment (i.e., chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ? Grade 1 per CTCAE, version 4.03 or are clinically stable and not clinically significant, at time of enrollment
Clinically significant hypercalcemia (including vomiting, dehydration and neurological symptoms)
Other clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this trial
Presence of clinically significant increased intracranial pressure (e.g. impending herniation) or hemorrhage, uncontrolled seizures, or requirement for immediate palliative treatment
Clinically significant pulmonary disease
Any other unstable or clinically significant concurrent medical condition
Subject with clinically significant wound
Significant obstructive symptoms (IPSS greater than 20)
Known clinically significant hypotension
Have altered immunity such as autoimmune disorders, clinically significant anemia, hemophilia, and blood dyscrasias
Any ongoing acute clinically significant toxic effect of prior anticancer therapy or any persisting complication of prior surgery.
Clinically significant psychiatric disease which, in the opinion of the PI or sub-investigator (I), would render immunotherapy and its potential sequelae unsafe or compliance with procedural requirements unlikely
Another malignancy that is clinically significant or requires active intervention (chemotherapy or radiation)
Uncontrolled clinically significant pulmonary disease.
Significant comorbidity (cirrhosis, severe coronary artery disease, significant psychiatric illness, or other that may compromise the ability to safely administer the therapy at the discretion of the primary investigator)
Clinically significant peripheral artery disease (e.g., claudication with < 1 block) or any other arterial thrombotic event
Clinically significant valvular heart disease
Concurrent disease or condition that would interfere with study participation or safety, such as:\r\n* Active, clinically significant infection requiring the use of parenteral anti-microbial agents, or grade > 2 by NCI CTCAE (v 4.03) within 14 days prior to enrollment\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders\r\n* Non-healing wound, ulcer, or bone fracture\r\n* Bone marrow disorder including myelodysplasia
Significant comorbidity: Patients with clinically significant and uncontrolled major disease or disorder that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit study compliance.
Clinically significant conditions that increase the risk for antiangiogenic therapy.
Treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug; clinically significant metabolic enzyme inducers are not permitted during this study
Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness)
Clinically significant acute pancreatitis within 12 weeks of treatment with protocol therapy as indicated by the presence of two of the three following criteria: abdominal pain in the epigastrium, often with radiation to the back, serum amylase and/or lipase greater than three times the upper limit of normal, and/or characteristic findings (peripancreatic inflammation, fat necrosis, etc.) from abdominal imaging; clinically significant will be defined as that requiring oral narcotics or hospital admission
Other serious illnesses or medical conditions including but not limited to:\r\n* Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry\r\n* History of significant neurologic or psychiatric disorders including dementia or seizures\r\n* Active clinically significant uncontrolled infection\r\n* Active peptic ulcer disease defined as unhealed or clinically active\r\n* Hypercalcemia \r\n* Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis\r\n* Chronic obstructive pulmonary disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensating within 12 months of diagnosis; this does not include obstruction from tumor\r\n* Autoimmune disease requiring therapy, prior organ transplant, or human immunodeficiency virus (HIV) infection \r\n* Interstitial lung disease\r\n* Hepatitis C by history
History of or presence of clinically significant ventricular or atrial tachyarrhythmias
Patients with a history of clinically significant cutaneous drug reaction to minocycline, as documented in the patient medical records
No significant immunodeficiency
History of or presence of clinically significant ventricular or atrial tachyarrhythmias
Clinically significant valvular heart disease
Presence of clinically relevant ascitis
Subject has a clinically significant peripheral artery disease, e.g., those with claudication, within 6 months
Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
Clinically significant cardiovascular disease defined as: i. Left ventricular ejection fraction (LVEF) ? 50%, measured within 3 months prior to Day 1 confirmed by ECHO/MUGA ii. Congestive heart failure requiring medical therapy iii. Chronic stable angina requiring medical therapy iv. Prior cerebrovascular accident with sequelae c. Clinically significant pulmonary disease defined as: i. Forced expiratory volume in 1 second (FEV1) ? 65% of expected ii. Lung diffusing capacity for carbon monoxide (DLCO) ? 65% of expected Confirmed by pulmonary tests. d. Diabetes mellitus with symptomatic end-organ damage (e.g., retinopathy, nephropathy, neuropathy, vasculopathy) e. Autoimmune inflammatory conditions (e.g., rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, or similar) requiring chronic disease modifying therapy (e.g., etanercept, adalimumab, infliximab, rituximab, methotrexate, or similar) f. Class III obesity defined as a Body Mass Index (BMI) > 40 kg/m2 g. Renal impairment defined as serum creatinine > 1.3 mg/dL (> 115 µmol/L) or creatinine clearance <70 ml/min h. Clinically significant cognitive impairment defined as requiring medical therapy and/or assistance with activities of daily living
History of significant cerebrovascular disease or event with significant symptoms
Patients with clinically significant co-morbid conditions, including, but not limited to: hypotension, chronic interstitial lung disease, uncontrolled diabetes
Clinically quantifiable disease burden defined as:
Has clinically significant heart disease that affects normal activities
History of clinically significant heart problems
Clinically significant glaucoma, retinitis pigmentosa, or macular degeneration.
Adequate recovery in the investigators opinion from any clinically significant toxicity from prior therapy
Clinically significant electrolyte imbalance ? Grade 2.
Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, thyroid, or metabolic disease; wound healing disorders; ulcers; or bone fractures)
Patients with clinically significant severe cardiorespiratory disease.
Patients with clinically significant ophthalmologic findings (as determined by an ophthalmologist) during screening should be excluded from the trial
Has a medical history of clinically significant lung diseases
Clinically significant electrolyte imbalance ? grade 2.
Within normal limit hematopoietic capacity, hepatic and renal function; values outside those limits may be allowed at the digression of the principle investigator (PI), if they are determined as not clinically significant
Known clinically important respiratory impairment
Other current, severe, uncontrolled systemic disease (e.g., clinically significant\n             metabolic disease, wound healing disorders, ulcers)
Scarring or significant skin disease on both upper arms.
Clinically significant hypotension
Clinically significant central nervous system disease defined as untreated, progressive, or requiring steroids for control of symptoms.
Clinically significant active pulmonary risk
History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other significant arrhythmias
Current severe, uncontrolled non-cancer systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) resulting in a life expectancy of < 6 months
Any other clinically significant heart disease
Clinically significant anemia unrelated to MDS
Clinically-significant thrombosis within 3 months of screening
Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures)
History of significant cerebrovascular disease or event with significant symptoms or sequelae.*
Lifetime history of suicidality, homicidality, or clinically significant hostility/aggression
Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases
Has a significant clinical disease or condition
Other clinically significant heart disease
Persistent clinically significant toxicities from prior chemo ? Grd 1
Persistent clinically significant toxicities from prior chemo ? Grd 1
History of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration
History of clinically significant haemoptysis within the past 3 months
Clinically significant encephalopathy
Clinically significant obstructive airway disease
Subjects must be free of any clinically significant disease other than cancer that would interfere with the study evaluations
Subjects must be free of any clinically significant disease other than cancer that would interfere with the study evaluations
Serum bilirubin < 2 x ULN, or considered not clinically significant by the study doctor or designee
Patient has clinically active diverticular disease
Significant psychiatric history
Married or cohabiting with a significant other of either gender for more than one year
Significant kidney disease that would inhibit administration of gabapentin
Manometry felt to be clinically indicated
Report a clinically significant level of FCR (as assessed with the Fear of Cancer Recurrence Inventory Short Form >= 13)
History of or current clinically significant immunodeficiency
History of or current clinically significant alloimmunization to leukocyte antigens
Clinically significant bacteremia or fungemia
Presence of clinically significant infections or congenital or acquired immunodeficiency
Subjects with clinically significant increased intracranial pressure (eg, impending herniation or requirement for immediate palliative treatment) or uncontrolled seizures
Unstable or clinically significant concurrent medical condition
Clinically significant edema requiring diuretic therapy
Be clinically stable
HEALTHY VOLUNTEER: Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder within the last 5 years; subjects who have had situational depression may be enrolled in the study at the discretion of the investigator
Has clinically significant corneal disease
History of clinically significant sensitivity or allergy to monoclonal antibodies, their excipients, or intravenous gamma globulin
Significant ophthalmologic abnormality,
Patients with clinically significant and unstable renal and/or liver disease (eg, transplant recipients in rejection)
Uncontrolled, clinically significant pulmonary disease.
no evidence of active/clinically significant bleeding. May be evidence of punctate hemorrhage w/in tumor as long as not considered clinically significant to warrant urgent surgical evacuation
Evidence of clinically significant immunosuppression
History of or presence of clinically significant ventricular or atrial tachyarrhythmias
Concomitant use or administration of clinically significant enzyme inducers less than or equal to (<=) 14 days before the first dose of TAK-580.
Evidence of clinically significant immunosuppression
is clinically unstable and/or
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise participation of the subject in the study
Other clinically significant comorbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient's participation in the study.
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise participation of the patient in the study
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient’s participation in the study.
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, active infection, or any other condition that could compromise participation of the participant in the study.
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise participation of the patient in the study
Any clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient’s participation in the study
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise participation of the patient in the study
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient’s participation in the study
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise participation of the patient in the study
Uncontrolled co-morbidities
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, active infection, or any other condition that might compromise the participant's participation in the study.
Clinically significant comorbidities such as uncontrolled pulmonary disease, active central nervous system disease, active infection, serious infection within 14 days before the first dose of study drug, or any other condition that could compromise study participation by the participant.
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, active infection
Other clinically significant co-morbidities
Has any clinically significant co-morbidities.
Clinically significant co-morbidities
Other clinically significant co-morbidities such as uncontrolled pulmonary disease, uncontrolled diabetes, active CNS disease, active infection or any other condition that could compromise the patients participation in the study according to the investigator
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system (CNS) disease, active infection, or any other condition that could compromise the subject's participation in the study
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient’s participation in the study
Any clinically significant comorbidities, such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease (specified below), active central nervous system disease, active infection, or any other condition that could compromise the participant's participation in the study. Participants with any of the following cardiovascular conditions are excluded:
Have any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (eg, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection).
Significant concurrent, uncontrolled medical condition
Concurrent severe and/or uncontrolled medical conditions, which may compromise participation in the study, including impaired heart function or clinically significant heart disease
The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
PART 1 EXCLUSION CRITERIA: Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., chronic medical or psychiatric condition or laboratory abnormality, uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection (including hepatitis A, B or C, human immunodeficiency virus [HIV] [testing is not mandatory])
PART 2 GROUP 1 EXCLUSION CRITERIA: Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., chronic medical or psychiatric condition or laboratory abnormality, uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection (including hepatitis A, B or C, human immunodeficiency virus [HIV] [testing is not mandatory])
PART 2 GROUP 2A EXCLUSION CRITERIA: Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., chronic medical or psychiatric condition or laboratory abnormality, uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection (including hepatitis A, B or C, human immunodeficiency virus [HIV] [testing is not mandatory])
PART 2 GROUP 3 EXCLUSION CRITERIA: Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., chronic medical or psychiatric condition or laboratory abnormality, uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection (including hepatitis A, B or C, human immunodeficiency virus [HIV] [testing is not mandatory])
Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
Uncontrolled, severe concomitant comorbidity (e.g. uncontrolled hypertension, uncontrolled diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study - e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection
Patients with any other known active cancer (except carcinoma in-situ), concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, pulmonary, chronic renal disease, active uncontrolled infection)
Concurrent severe and/or uncontrolled medical conditions which may compromise participation in the study, including impaired heart function or clinically significant heart disease
Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Any other concurrent severe known disease (except carcinoma in-situ) or concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, or active uncontrolled infection) which could compromise participation in the study
Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., uncontrolled diabetes mellitus defined by a glucose greater than 1.5 ULN in spite of adequate medical treatment, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Any other known disease (except carcinoma in-situ), concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, cardiovascular disease including congestive heart failure, myocardial infarction within 6 months and poorly controlled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study; other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretation
Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g., uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (i.e. uncontrolled diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection).
Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (e.g. uncontrolled hypertension and/or diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection).
Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Cardiovascular Risks as outlined in the protocol.
Any of the following cardiovascular criteria:
Has a history of or current uncontrolled cardiovascular disease
History or evidence of cardiovascular risk
History or evidence of cardiovascular risk
History of uncontrolled cardiovascular disease including
Any known uncontrolled cardiovascular disease;
Evidence of significant cardiovascular conditions as specified below:
History of cardiovascular disease
Cardiovascular disorders
Uncontrolled cardiovascular history, defined as:
Has cardiovascular risk factors
History or current condition of an uncontrolled cardiovascular disease including any of the following conditions:
Predefined cardiovascular disease
Acute cardiovascular disease in the previous 30 days
No known history of cardiovascular disease
History of cardiovascular illness;
History of specific cardiovascular abnormalities;
Has a history of any of the following cardiovascular conditions within 12 months of randomization:
History or evidence of cardiovascular risk including any of the following:
Serious cardiac or cardiovascular disease or condition
Have a history or current evidence of uncontrolled cardiovascular disease.
History or evidence of cardiovascular condition
History of any one or more of the following cardiovascular conditions within the past 6 months:
Cardiovascular conditions as defined in the protocol
Evidence of current uncontrolled cardiovascular conditions
History or current evidence of cardiovascular risk.
Participants with cardiovascular conditions specified in protocols
Patients must not have cardiovascular disease risk factors as defined below:
Evidence of current uncontrolled cardiovascular conditions within the past 6 months
unstable cardiovascular function
History of certain cardiovascular conditions within the past 6 months.
Prior therapy with known risk for cardiovascular complications.
History or evidence of cardiovascular risk including any of the following:
Any of the following cardiovascular conditions:
A history or evidence of cardiovascular risk including any of the following:
A history or evidence of cardiovascular risk- specific criteria have to be met
History of serious cardiovascular disease
Evidence of uncontrolled cardiovascular conditions
A history or evidence of cardiovascular risk including any of the following
History or current condition of uncontrolled cardiovascular disease
Patients with the following manifestations of cardiovascular disease are excluded:
Evidence of current uncontrolled cardiovascular conditions
History of certain cardiovascular conditions within the past 6 months.
Participants with certain cardiovascular conditions are excluded.
Participants with any of the following cardiovascular conditions are excluded:
Cardiovascular disease
Unstable cardiovascular disease in the last 6 months
Any prior cardiovascular disease
unstable pulmonary or cardiovascular conditions.
Not be undergoing evaluation and workup for active cardiovascular disease; men with treated and stable cardiovascular disease may participate
Acute major illness (e.g., unstable cardiovascular condition, etc.)
Acute major illness (e.g., unstable cardiovascular condition, etc.)
Acute major illness (e.g., infection, unstable cardiovascular condition, etc.)
Acute major illness (e.g. unstable cardiovascular condition, etc.)
Active, unstable cardiovascular function:
Have any of the following cardiovascular conditions:
Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease, cardiovascular disease, and presence of an abnormal electrocardiogram (ECG)
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases or other disease with ongoing fibrosis
Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the patient, including renal disease that would preclude chemotherapy administration or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm).
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the patient, including renal disease that would preclude chemotherapy administration or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant pulmonary disease other than primary cancer, uncontrolled diabetes mellitus, and/or significant cardiovascular disease (such as New York Heart Association class III or IV cardiac disease, myocardial infarction within the last 6 months, uncontrolled arrhythmias, unstable angina, non-compensative congestive heart failure, or clinically significant pericardial effusion)
Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant pulmonary disease other than that related to the primary cancer, uncontrolled diabetes mellitus, and/or significant cardiovascular disease (such as New York Heart Association class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina, or clinically significant pericardial effusion)
Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant pulmonary disease other than primary cancer, uncontrolled diabetes mellitus, and/or significant cardiovascular disease (such as New York Heart Association class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina, or clinically significant pericardial effusion)
Evidence or history of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association class III or IV cardiac disease, severe arrhythmia, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or contraindicate the use of an investigational drug, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm)
Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant pulmonary disease other than primary cancer, uncontrolled diabetes mellitus, and/or significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina, or clinically significant pericardial effusion)
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm)
Evidence of significant uncontrolled concomitant disease that in the opinion of the investigator could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)