No clinically significant infections as judged by the treating investigator
N or N disease detected clinically or by imaging
Uncontrolled clinically significant arrhythmias.
Has a medical history of clinically significant lung disease
Clinically significant anemia due to non-MDS etiologies
Treatment with clinically significant metabolic CYPA inducers within days before the first dose of study drug; clinically significant CYPA inducers are not permitted during the study
Participant has clinically significant uncontrolled conditions.
Current diagnosis of any other active or clinically significant nonbreast cancer
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 > hours;
Have any clinically significant disease considered by the investigator to interfere with study participation
Has clinically significant heart disease that affects normal activities.
Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or central nervous system disorders.
Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial
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.
Clinically significant active infection, in the judgment of the investigator
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 ) changes in AST, ALT, ALP, bilirubin, or GGT values.
Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
Evidence of increased intracranial pressure (clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
Clinically significant, uncontrolled heart disease
No clinically significant infections as judged by the treating investigator
TREATMENT WITH SJCAR: Electrocardiogram (EKG) without evidence of clinically significant arrhythmia
Evidence of increased intracranial pressure (midline shift > mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness)
Evidence of increased intracranial pressure (midline shift > 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
Concurrent clinically significant infections as determined by the treating Investigator.
Has clinically significant lung disease or is suspected to have such diseases by imaging at Screening
Treatment with clinically significant metabolic inducers within 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 days before the first dose of the study drug; clinically significant metabolic enzyme inducers are not permitted during this study
No clinically significant infections as judged by the treating investigator
Any clinically significant uncontrolled concomitant disease
Has any other clinically significant abnormal laboratory value in the opinion of the investigator
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
clinically significant active infection
clinically significant CNS disorder
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
Clinically significant dry eye or contact lens use
Patients with any clinically significant autoimmune disease uncontrolled with treatment
Active or clinically significant Gastric Antral Vascular Ectasia (GAVE, \watermelon stomach\)
Treatment with clinically significant metabolic enzyme inducers within days before the first dose of the study drug; clinically significant metabolic enzyme inducers are not permitted during this study (CYPA/ inducers)
No clinically significant infections or any other medical condition(s) that render the subject ineligible for high dose IL- therapy as judged by the treating investigator
History of clinically significant auditory or ocular toxicity with ICT
Patients with clinically significant cardiomyopathy requiring treatment
No clinically significant uncontrolled infections as determined by investigator
No clinically significant infections as judged by the treating investigator
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 uncontrolled condition(s) s described in the protocol.
Subject has a clinically significant peripheral artery disease, e.g., those with claudication, within months
Has any clinically significant infection
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 clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
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
Clinically significant uncontrolled illness
Patients with any clinically significant autoimmune disease uncontrolled with treatment
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
Evidence of clinically significant neuropathy (> Grade ) by physical exam.
Any Grade or higher lab abnormalities should be discussed and approved by the Medical Monitor prior to enrollment (even if not considered clinically significant);
Treatment with clinically significant metabolic enzyme inducers within days before the first dose of the study drug; clinically significant metabolic enzyme inducers are not permitted during this study
Clinically significant, uncontrolled heart diseases
Electrocardiogram (EKG) without clinically significant abnormality
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
No clinically significant infections as judged by the treating investigator
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
- Participant has clinically significant uncontrolled condition(s) as described in the protocol.
Clinically significant surgery within weeks of enrollment.
Active clinically significant infection
Active clinically significant infection within -days of study treatment.
History or evidence of current clinically significant uncontrolled arrhythmias
Known, clinically significant carotid artery disease
Any clinically significant electrolyte imbalance, particularly hypokalemia and hypomagnesemia, should be corrected before treatment
Uncontrolled and clinically significant disease-related metabolic disorder
Patients must not have clinically significant autoimmune disease that requires treatment with immunosuppressant medications
Any clinically significant active infection that requires systemic treatment at the time of enrollment
Clinically significant resting bradycardia
Treatment for clinically-significant hyperglycemia, hyperlipidemia, or hypertension that develops on study is required
Clinically significant uncontrolled condition(s).
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
Any sign of clinically significant bleeding
Clinically significant organ/system disease unrelated to RCC that in the judgment of the investigator should preclude treatment with dalantercept or axitinib.
Evidence of active tuberculosis or recent (< week prior to first scheduled dosing) clinically significant infection requiring systemic therapy.
Has a medical history of clinically significant lung disease
Clinically significant heart disease
Has all prior treatment (i.e., chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ? Grade per NCI CTCAE, Version . 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:
Patients who have received treatment with clinically significant enzyme inducers within days prior to registration are not eligible
Has all prior treatment (i.e., chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ? Grade per CTCAE, version . or are clinically stable and not clinically significant, at time of enrollment
Have ongoing clinically significant adverse event(s) due to prior treatments administered as determined by the investigator.
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
Clinically significant pulmonary disease
Subject with clinically significant wound
Serum bilirubin < x upper limit of normal, or considered not clinically significant by the study doctor or designee
Known clinically significant hypotension
Known clinically significant autoimmune disorders requiring on-going systemic immune-suppression for control
Have altered immunity such as autoimmune disorders, clinically significant anemia, hemophilia, and blood dyscrasias
Another malignancy that is clinically significant or requires active intervention (chemotherapy or radiation)
No clinically significant infections as judged by the treating investigator.
Uncontrolled clinically significant pulmonary disease.
History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or drug intake
Clinically significant uncontrolled condition(s)
Clinically significant peripheral artery disease (e.g., claudication with < block) or any other arterial thrombotic event
Have current or prior history of infection or clinically significant adverse events (AEs) associated with an exogenous implant(s) or device(s) that cannot be easily removed
Clinically significant valvular heart disease
Patients with clinically significant cardiomyopathy requiring treatment
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 > by NCI CTCAE (v .) within 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
No arrhythmia interpreted by the study cardiologist to be clinically significant
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 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 > mm, clinically significant papilledema, vomiting and nausea, or reduced level of consciousness)
History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or oral drug intake
Clinically significant acute pancreatitis within 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
Clinically significant resting bradycardia
Patients with a history of clinically significant cutaneous drug reaction to minocycline, as documented in the patient medical records
History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or oral drug intake
No significant immunodeficiency
History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or oral drug intake
Clinically significant valvular heart disease
Presence of clinically relevant ascitis
Subject has a clinically significant peripheral artery disease, e.g., those with claudication, within months
Clinically significant illness that requires medical treatment within weeks or a clinically significant infection that requires medical treatment within weeks of dosing
Clinically significant cardiovascular disease defined as: i. Left ventricular ejection fraction (LVEF) ? %, measured within months prior to Day 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 second (FEV) ? % of expected ii. Lung diffusing capacity for carbon monoxide (DLCO) ? % 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) > kg/m g. Renal impairment defined as serum creatinine > . mg/dL (> mol/L) or creatinine clearance < ml/min h. Clinically significant cognitive impairment defined as requiring medical therapy and/or assistance with activities of daily living
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 systemvascular, cardiac, pulmonary, hepatic, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine or immunodeficiency, autoimmune or clinically significant active psychiatric disorders)
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:
Uncontrolled clinically significant arrhythmias
Has clinically significant heart disease that affects normal activities
History of clinically significant heart problems
Clinically significant electrolyte imbalance ? Grade .
Evidence of increased intracranial pressure (midline shift > mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
Ongoing or clinically significant active infection as judged by the investigator.
Ongoing or clinically significant active infection as judged by the investigator.
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
Clinically significant electrolyte imbalance ? grade .
Active and clinically significant systemic or localized infection.
Any sign of clinically significant bleeding
History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or oral drug intake
Clinically significant bleeding within days before enrollment
Clinically significant bleeding within days of study Day
Clinically significant hypotension
Clinically significant autoimmune disorders requiring on-going systemic immune-suppression for control
Clinically significant central nervous system disease defined as untreated, progressive, or requiring steroids for control of symptoms.
A history or evidence of current clinically significant uncontrolled arrhythmias;
Clinically significant active pulmonary risk
History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other significant arrhythmias
Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\r\n* Active systemic fungal infection\r\n* Diagnosis of fever and neutropenia within week prior to study drug administration
Clinically significant resting bradycardia
Any other clinically significant heart disease
Clinically significant anemia unrelated to MDS
No evidence of a clinically significant active infection
Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or central nervous system disorders
Clinically significant abnormalities of glucose metabolism.
Clinically-significant thrombosis within months of screening
Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
Lifetime history of suicidality, homicidality, or clinically significant hostility/aggression
Clinically significant resting bradycardia
Other clinically significant heart disease
Persistent clinically significant toxicities from prior chemo ? Grd
Persistent clinically significant toxicities from prior chemo ? Grd
History of any clinically significant local or systemic infectious disease within weeks prior to initial treatment administration
No clinically significant infections as judged by the treating investigator.
Clinically significant obstructive airway disease
Subjects must be free of any clinically significant disease other than cancer that would interfere with the study evaluations
Any clinically significant electrolyte imbalance, particularly hypokalemia and hypomagnesemia, should be corrected before treatment
Subjects must be free of any clinically significant disease other than cancer that would interfere with the study evaluations
Serum bilirubin < x ULN, or considered not clinically significant by the study doctor or designee
Patient has clinically active diverticular disease
Patients with clinically significant illnesses which, according to the Investigator, could compromise participation in the study;
Uncontrolled clinically significant arrhythmia in last months.
Married or cohabiting with a significant other of either gender for more than one year
Manometry felt to be clinically indicated
Report a clinically significant level of FCR (as assessed with the Fear of Cancer Recurrence Inventory Short Form >= )
Concurrent clinically significant infections as determined by the treating investigator.
Clinically significant uncontrolled condition(s).
Clinically significant gastrointestinal disorder
Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI)
Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI)
History of or current clinically significant immunodeficiency
History of or current clinically significant alloimmunization to leukocyte antigens
Patient has acute bleeding that is clinically significant within hours before the start of study treatment.
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
Clinically significant edema requiring diuretic therapy
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Be clinically stable
Liver enzymes without clinically significant abnormalities after review by the study physicians
Active clinically significant infection
Significant ophthalmologic abnormality,
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
Clinically significant resting bradycardia
Concomitant use or administration of clinically significant enzyme inducers less than or equal to (<=) days before the first dose of TAK-.
Clinically significant active infection
is clinically unstable and/or