Patients who have had an echocardiogram performed within 6 months prior to step 2 randomization must have ventricular ejection fraction (left ventricular ejection fraction [LVEF]) >= 50% or >= within normal limits for the institution
Patients must have ejection fraction >= 45% based on echocardiogram performed within 28 days prior to registration
Transthoracic echocardiogram with ejection fraction > 50%
Cardiac ejection fraction (left ventricular ejection fraction [LVEF]) >= 50% by echocardiogram =< 28 days prior to registration
Left ventricular ejection fraction (LVEF) >= 50% calculated by echocardiogram (ECHO)
EXPANDED ACCESS COHORT: Participants must have adequate cardiac function, defined as:\r\n* Left ventricular ejection fraction (LVEF) >= 50% as determined by echocardiogram (ECHO) or MUGA\r\n* QTcF =< 480 msec on screening electrocardiogram (ECG)
PART I: Baseline left ventricular ejection fraction (LVEF) by 2 dimensional (2D) echocardiogram >= 53%
PART II: Baseline LVEF by 2D echocardiogram >= 55%
Echocardiogram demonstrated left ventricular ejection fraction >= 40%.
Left ventricular ejection fraction < 40% as measured on transthoracic echocardiogram
Left ventricular ejection fraction (LVEF) < 50% as assessed by echocardiogram or radionuclide angiography
Within two weeks prior to enrollment: Left ventricular ejection fraction (LVEF) >= 50% as determined an echocardiogram
Left ventricular ejection fraction (LVEF) < 50% as assessed by echocardiogram or radionuclide angiography
Left ventricular ejection fraction (LVEF as determined by cardiac echo or MUGA scan) below the normal limits of the institutions specific testing range. This assessment may be repeated once at the discretion of the Investigator with the approval of the Sponsor.
Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) of ? 50% as assessed by echocardiogram or MUGA scan, or LVEF of 45-49% and clearance by a cardiologist; if subject receives cardiotoxic chemotherapy after enrollment, repeat echocardiogram or MUGA is required to reestablish eligible LVEF
Echocardiogram demonstrating left ventricular ejection fraction (LVEF) >= 35%
Left ventricular ejection fraction (LVEF) ejection fraction (EF) >= of 50% (by echocardiogram or MUGA scan within 12 weeks of registration), within 2 weeks of registration (except where specified otherwise)
Left ventricular ejection fraction (LVEF as determined by cardiac echo or MUGA scan) below the normal limits of the institutions specific testing range. This assessment may be repeated once at the discretion of the Investigator with the approval of the Sponsor.
Left ventricular ejection fraction (LVEF) < 50% as assessed by echocardiogram or radionuclide angiography
Patients with left ventricular ejection fraction < 50% or 10% decrease from baseline on echocardiogram after anthracycline based chemotherapy
Left ventricular ejection fraction (LVEF) assessed by echocardiogram within 3 months prior to initiation of study treatment indicates an LVEF of >= 50%
Left ventricular ejection fraction (LVEF) < 50% (evaluated by echocardiogram or magnetic resonance imaging [MRI])
Left ventricular ejection fraction: < 40% estimated by echocardiogram (ECHO)
LVEF < 50% and >= 40% documented in echocardiogram done within the last 30 days
RECIPIENT: Left ventricular ejection fraction > 40%, preferably by 2-dimensional (2-D) echocardiogram (echo) obtained within 28 days of enrollment
Left ventricular ejection fraction > 40%, preferably by two dimensional (2-D) echocardiogram (ECHO), obtained within 90 days of enrollment; if the patient has radiological evidence of aortic, renal artery, or coronary artery vasculitis, a left ventricular ejection fraction > 30% is acceptable
Normal echocardiogram (ECHO) (Left ventricular ejection fraction [LVEF] has to be within normal, institutional limits)
Left ventricular ejection fraction (LVEF) >= 45% as measured by echocardiogram during screening evaluation
Echocardiogram with normal ejection fractions
Left ventricular ejection fraction (LVEF) assessment (eg, echocardiogram, radionuclide ventriculogram scan [MUGA], first-pass technique) performed within 3 months prior to initiation of study treatment indicates an LVEF of >= 50%
Symptomatic congestive heart failure or radionuclide ventriculogram (RVG) or echocardiogram determined left ventricular ejection fraction of < 30%, active angina pectoris, or uncontrolled hypertension
Within 30 days of registration: Left ventricular ejection fraction (echocardiogram within 6 months permitted) >= 40%
Subjects who have a left ventricular ejection fraction (LVEF) < 50%, as assessed by echocardiogram performed at screening
Patients must have either echocardiogram (ECHO) with ejection fraction >= 45% within 28 days prior to registration
Normal echocardiogram (ECHO) (left ventricular ejection fraction [LVEF] has to be within normal, institutional limits)
Left Ventricular Shortening Fraction (LVSF) ? 28% confirmed by echocardiogram, or Left Ventricular Ejection Fraction (LVEF) ? 45% confirmed by echocardiogram or MUGA within 7 days of screening
Hemodynamically stable and Left Ventricle Ejection Fraction (LVEF) ? 45% confirmed by echocardiogram or Multigated Radionuclide Angiography (MUGA)
Left ventricular ejection fraction (LVEF) ? 40% as measured by MUGA scan or 2-D ECHO within 28 days prior to start of therapy and no clinically significant abnormalities on a 12-lead ECG
Left ventricular ejection fraction (LVEF) ? 40% as measured by MUGA scan or 2-D ECHO within 28 days prior to start of therapy and no clinically significant abnormalities on a 12-lead ECG
Symptomatic congestive heart failure or evidence of left ventricular dysfunction (ejection fraction < 40%) as measured by gated radionucleotide ventriculogram or echocardiogram; active angina pectoris, or uncontrolled hypertension
Active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year; if echocardiogram (ECHO) is obtained the left ventricular ejection fraction (LVEF) should exceed 40%
Baseline ejection fraction ? 50% as assessed by echocardiogram or MUGA.
PHASE II: Left ventricular ejection fraction (LVEF) >= 50% calculated by echocardiogram (ECHO)
Left ventricular ejection fraction (LVEF) of at least 50% as determined by MUGA or echocardiogram
Baseline (< 1 month before treatment) cardiac left ventricular function with resting ejection fraction of less than 50% measured by echocardiogram
Left ventricular ejection fraction (LVEF) < 50% as assessed by echocardiogram or radionuclide angiography
Left ventricular ejection fraction >= 50%, as determined by radionuclide ventriculography (RVG) or echocardiogram within 60 days prior to initiation of protocol therapy
Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy.
Normal cardiac function defined as either a MUGA or echocardiogram (ECHO) with left ventricular ejection fraction (LVEF) in normal institutional range (MUGA 50%; ECHO 55%)
Left ventricular ejection fraction >= 50%, as determined by RVG (MUGA) or echocardiogram within 60 days prior to initiation of extension phase therapy (all cohorts)
Active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year; if echocardiogram (ECHO) is obtained, the left ventricular ejection fraction (LVEF) should exceed 40%
LVEF < 45% by echocardiogram
Left ventricular ejection fraction <50% as determined by echocardiogram (ECHO) performed at screening or within 30 days prior to C1D1
Patients will be ineligible for treatment on this protocol if:\r\n* There is a history of a recent myocardial infarction (within one year)\r\n* There is a history of a past myocardial infarction (more than one year ago) along with current coronary symptoms requiring medications and/or evidence of depressed left ventricular function (left ventricular ejection fraction [LVEF] < 45% by echocardiogram [ECHO])\r\n* There is a current history of angina/coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF < 45% by ECHO)\r\n* There is clinical evidence of congestive heart failure requiring medical management (irrespective of ECHO results)
Adequate heart function with echocardiogram demonstrating ejection fraction >= 45% with no evidence of systolic dysfunction
Baseline cardiac echocardiogram scan with left ventricular ejection fraction (LVEF) of >= 50%
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Cardiac function: \r\n* Left ventricular ejection fraction >= 50 by gated radionuclide study OR shortening fraction of >= 27% by echocardiogram\r\n* Patient has no ventricular arrhythmias except for benign premature ventricular contractions\r\n* Patient has a corrected QT (QTc) interval =< 450 ms
Left ventricular ejection fraction (LVEF) < 45% as determined by MUGA scan or echocardiogram (ECHO).
Left ventricular ejection fraction (LVEF) >50% per ECHO or MUGA for patients on the sunitinib arms (Parts 2e and f).
Patients with a left ventricular cardiac ejection fraction < 50% as assessed by an echocardiogram or MUGA scan
Left ventricular ejection fraction < 50% as assessed by echocardiogram or radionuclide angiography.
Subjects with a left ventricular cardiac ejection fraction < 50% as assessed by an echocardiogram or MUGA scan
Left ventricular ejection fraction (LVEF) ?50% by echocardiogram
Left ventricular ejection fraction (LVEF) <40%, as determined by screening echocardiogram (echocardiogram results obtained within 90 days prior to screening are acceptable)
Left ventricular ejection fraction (LVEF) < 50% by MUGA or echocardiogram
Adequate cardiac function measured by left ventricular ejection fraction (LVEF) > 50%; if asymptomatic, pre-transplant echocardiogram is adequate; if symptomatic, echocardiogram needs to be repeated
LVEF (measured by Echocardiogram) > 50%
Spirometry with at least 70% of predicted volumes (including FEV1). A left ventricular ejection fraction (LVEF) of 45% or more. All patients will have a screening 2-D Echocardiogram as part of eligibility screening.
History of myocardial infarction (MI) or NYHA Class II-IV congestive heart failure within 6 months of the administration of the first dose of ARQ 092 (MI occurring >6 months of the first dose of ARQ 092 will be permitted); Grade 2 or worse conduction defect (eg right or left bundle branch block); left ventricular ejection fraction (LVEF) < 50% assessed by echocardiogram/MUGA scan
MUGA/Echocardiogram Left Ventricular Ejection Fraction < 50%.
If in Arm D (doxorubicin and cyclophosphamide), left ventricular ejection fraction (LVEF) >= 50% as measured by echocardiogram (ECHO) within 4 weeks prior to study drug administration
Ejection fraction < 50% on echocardiogram (ECHO) or MUGA
Baseline screening echocardiogram (echo) left ventricular ejection fraction (LVEF) =< 50
Left ventricular ejection fraction < 45% (evaluated by echocardiogram or MUGA scan)
Left ventricular ejection fraction < 50% (evaluated by echocardiogram or MUGA)