Abnormal ECHO or MUGA at baseline <%.
Abnormal cardiac function defined by a LVEF <% by ECHO or MUGA
EXPANDED ACCESS COHORT: Participants must have adequate cardiac function, defined as:\r\n* Left ventricular ejection fraction (LVEF) >= % as determined by echocardiogram (ECHO) or MUGA\r\n* QTcF =< msec on screening electrocardiogram (ECG)
Left ventricular ejection fraction >= % by dimensional (D) echocardiogram (ECHO) or multigated acquisition (MUGA) scan, or left ventricular shortening fraction >= % by ECHO for patients receiving MAC, RIC or RIC-MMF, or LVEF > %; if the patient has radiologic evidence of aortic, renal, or coronary artery vasculitis, LVEF >= % for patients receiving IOC
Has a left ventricular ejection fraction (LVEF) ?% by either an ECHO or MUGA within days before registration
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.
Has a history of significant cardiac disease, including:\r\n* History of a recent myocardial infarction (within one year), a past myocardial infarction (more than one year ago) along with current coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF < % by multigated acquisition [MUGA] or echocardiogram [ECHO])\r\n* Current history of angina/coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF < % by MUGA or ECHO)\r\n* Clinical evidence of congestive heart failure requiring medical management (irrespective of ECHO results)
Left ventricular ejection fraction greater than (>) % as measured by ECHO or MUGA scan within weeks before receiving the first dose of study drug.
Impaired cardiac function (left ventricular ejection fraction [LVEF] < %) as assessed by echocardiography (ECHO) or radionuclide ventriculogram (MUGA) scan
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) >= % on ECHO or MUGA
Left ventricular ejection fraction equal to or greater than normal within month of enrollment; echocardiography (ECHO) scans must be used throughout the study
Patients will be ineligible for treatment on this protocol if (prior to protocol entry):\r\n* There is a history of a recent (within one year) myocardial infarction\r\n* There is a current or prior history of angina/coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF < % by MUGA or ECHO)\r\n* There is clinical evidence of congestive heart failure requiring medical management (irrespective of MUGA or ECHO results)
Left ventricular ejection fraction (LVEF) ? % as measured by MUGA scan or -D ECHO within days prior to start of therapy and no clinically significant abnormalities on a -lead ECG
Left ventricular ejection fraction (LVEF) ? % as measured by MUGA scan or -D ECHO within days prior to start of therapy and no clinically significant abnormalities on a -lead ECG
Patients with a known history of congestive heart failure or cardiac ejection fraction < % (or less than institutional normal limits); echocardiogram (ECHO) or multigated acquisition scan (MUGA) is not required prior to enrollment; for patients assigned to the chemotherapy arm, an ECHO or MUGA should be done within months of day of gemcitabine-docetaxel treatment\r\n* Patients who enroll on study and are randomized to Regimen I (chemotherapy ) and then are found on baseline ECHO or MUGA to have cardiac ejection fraction < % or below institutional normal will remain ON study; such patients will receive gemcitabine + docetaxel for cycles but will NOT receive any doxorubicin treatment; they will continue treatment follow-up as outlined for all patients assigned to Regimen I
Patients must have an EKG and ECHO or MUGA scan prior to entering the study.
Normal LVEF per institutional criteria as determined by either ECHO or MUGA scanning.
have major abnormalities documented by echocardiography (ECHO) with Doppler (for example, moderate or severe heart valve function defect and/or left ventricular ejection fraction <%, evaluation based on the institutional lower limit of normal). For additional details, refer to ECHO protocol.
Normal cardiac function defined as either a MUGA or echocardiogram (ECHO) with left ventricular ejection fraction (LVEF) in normal institutional range (MUGA %; ECHO %)
The patient has LVEF ?% by ECHO or MUGA scan and no clinically significant abnormalities in -lead ECG
Subjects must have a MUGA scan or echo with LVEF >%
Participants with a history of chronic heart failure must have cardiac ECHO indicating left ventricular ejection fraction (LVEF) ? % within days prior to first dose of study drug
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] < % 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 < % by ECHO)\r\n* There is clinical evidence of congestive heart failure requiring medical management (irrespective of ECHO results)
Left ventricular ejection fraction (LVEF) < % as determined by MUGA scan or ECHO
Left ventricular ejection fraction (LVEF) < % as determined by MUGA scan or echocardiogram (ECHO).
Left ventricular ejection fraction (LVEF) >% per ECHO or MUGA for patients on the sunitinib arms (Parts e and f).
Cardiac ejection fraction ?% by ECHO or MUGA
Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < % (or below the study site's lower limit of normal) as measured by MUGA or ECHO.
Left ventricular ejection fraction (LVEF) ?institutional lower limit of normal as measured by multigated acquisition scan (MUGA) or -dimensional (-D) echocardiography (ECHO) within days prior to start of therapy and no clinically significant abnormalities on a -lead electrocardiogram (ECG)
LVEF <% as determined by MUGA or echo
Cardiac ejection fraction ?% by ECHO or MUGA
Significant cardiovascular disease, including:\r\n* Symptomatic left ventricular dysfunction or known baseline left ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or echocardiogram (ECHO) of < lower limit of institutional normal (LLN); \symptomatic\ is defined as New York Heart Association (NYHA) class II or greater; Note: MUGA and ECHO do not need to be measured to establish eligibility for this study\r\n* Uncontrolled hypertension (in the opinion of the treating provider)\r\n* Myocardial infarction, severe angina, or unstable angina within months prior to administration of first dose of study drug\r\n* History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) within months of first dose of study drug\r\n* Uncontrolled cardiac arrhythmias\r\n* Coronary or peripheral artery bypass graft within months of first dose of study drug\r\n* History of cerebrovascular accident (CVA), transient ischemic attack (TIA), or rest claudication within months of first dose of study drug
LVEF ? % by MUGA or ECHO
A normal ejection fraction, as defined by the participants institution; only limited echocardiograms (ECHOs) will be used as cardiac evaluation; no other tests are allowed; ECHO is to be done only in HLA-A positive participants; If ECHO has been done within days prior to randomization and results showing a normal ejection fraction have been obtained prior to randomization, an additional ECHO is not needed at baseline
Patients with an ejection fraction < % assessed by MUGA or ---ECHO within days prior to starting study cycle (of midostaurin or control group)
Left ventricular ejection fraction (LVEF) by echocardiography (ECHO) or multiplegated acquisition (MUGA) within normal range (according to institutional standards).
Left ventricular ejection fraction (LVEF) < % as measured by echocardiography or MUGA scan performed at Screening