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