Patients with QTc interval > 470 milliseconds
Patients with baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Corrected QT (QTc) interval =< 480 milliseconds
Corrected QT (QTc) interval =< 480 milliseconds
Marked baseline prolongation of QT/corrected QT (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
Corrected QT interval (QTc) of < 480 milliseconds
Prolongation of QT corrected (QTc) interval to >480 milliseconds (ms)
Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/QTc ([QT interval/corrected QT interval], e.g., a repeated demonstration of a QTc interval > 500 ms)
Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/ corrected QT (QTc) ([QT interval/corrected QT interval], eg, a repeated demonstration of a QTc interval > 500 ms)
Baseline QTc prolongation (e.g., repeated demonstration of QTc interval > 480 milliseconds or history of congenital long QT syndrome or torsades de pointes)
History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful. Screening corrected QT (QTc) interval > 470 msec is excluded (corrected by Fridericia). If a single QTc is > 470 milliseconds, the subject may enroll if the average QTc for the 3 ECGs is < 470 milliseconds. For subjects with an intraventricular conduction delay (QRS interval > 120 milliseconds), the JTc interval may be used in place of the QTc with sponsor approval. The JTc must be < 340 milliseconds if JTc is used in place of the QTc. Subjects with left bundle branch block are excluded. Note: QTc prolongation due to pacemaker may enroll if the JTc is normal or with medical monitor approval.
Baseline corrected QT (QTc) interval >= 480 milliseconds
No previous history of corrected QT (QTc) prolongation as a result of medication that required discontinuation of that medication
History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful; screening corrected QT (QTc) interval > 470 milliseconds is excluded; in the event that a single QTc is > 470 milliseconds, the subject may enroll if the average QTc for the 3 ECGs is < 470 milliseconds; for subjects with an intraventricular conduction delay (QRS interval > 120 milliseconds), the corrected JT (JTc) interval may be used in place of the QTc with sponsor approval; the JTc must be < 340 milliseconds if JTc is used in place of the QTc; subjects with left bundle branch block are excluded\r\n* Note: QTc prolongation due to pacemaker may enroll if the JTc is normal
History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful; screening corrected QT (QTc) interval >= 480 milliseconds is excluded; in the event that a single QTc is >= 480 milliseconds, the subject may enroll if the average QTc for the 3 ECGs is < 480 milliseconds; for subjects with an intraventricular conduction delay (QRS interval > 120 milliseconds), the corrected JT (JTc) interval may be used in place of the QTc with the approval of the principal investigator; the JTc must be < 340 milliseconds if JTc is used in place of the QTc; subjects with left bundle branch block are excluded; note: QTc prolongation due to pacemaker may enroll if the JTc is normal
Baseline prolongation of the rate-corrected QT interval (QTc) > 480 milliseconds or history of congenital long QT syndrome or Torsades de pointes
Concomitant use of a drug with a known risk of corrected QT interval (QTc) prolongation
Known QT interval prolongation
Prolongation of corrected QT (QTc) interval to >480 milliseconds (msec) when electrolyte balance is normal
Corrected QT (QTc) interval > 0.450 seconds (males) or > 0.470 seconds (females), or known history of QTc prolongation or Torsade de Pointes (TdP)
Marked baseline prolongation of QT/corrected QT interval (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
Baseline prolongation of the rate-corrected QT interval (QTc; example, repeated demonstration of QTc interval > 480 millisecond [ms], or history of congenital long QT syndrome, or torsades de pointes).
Marked baseline prolongation of QT/corrected QT (QTc) interval (QTc interval >= 500 msec) using the Fridericia method (QTc = QT/RR0.33) for QTc analysis
Corrected QT (QTc) interval > 480 ms (>= grade 2) on a 12-lead electrocardiogram (ECG)\r\n* If baseline QTc on screening ECG is >= grade 2:\r\n** Check potassium and magnesium serum levels\r\n** Correct any identified hypokalemia and/or hypomagnesemia and repeat ECG to confirm exclusion of patient due to QTc\r\n* For patients with heart rate < 60 beats per minute (bpm) or > 100 bpm, manual read of the QT interval by a cardiologist is required, with Fridericia correction applied to determine Fridericia QTc (QTcF) which must be used to determine eligibility\r\n* Note: If heart rate is 60-100 bpm, manual read of the QT interval and correction to QTcF is not required
Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant (such as acute ischemia, left bundle branch block, ventricular arrhythmias) or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval > 480 milliseconds)
Baseline prolongation of the rate-corrected QT interval (QTc) (e.g. repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsades de pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged corrected QT (QTc) interval (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females); valvular, ischemic, or pulmonary heart disease; cardiomyopathy; history of heart failure
Screening corrected QT interval (QTc) interval > 470 milliseconds
Marked baseline prolongation of QT/corrected QC (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
Corrected QT interval (QTc) prolongation > 450 milliseconds (msec)
Prolongation of QTc interval to >480 milliseconds (ms)
Prolongation of QT interval (QT)/corrected QT interval (QTc) (QTc interval > 470 ms) using the Fridericia method of QTc analysis
Corrected QT (QTc) interval =< 480 milliseconds
Baseline electrocardiogram (EKG) shows normal corrected QT interval (QTc) interval of =< 470 milliseconds (ms)
Corrected QT (QTc) interval > 450 ms on screening 12-lead electrocardiogram (ECG)\r\n* If baseline QTc on screening ECG meets exclusion criteria:\r\n** Check calcium, potassium, and magnesium serum levels\r\n** Correct any identified hypocalcemia, hypokalemia, and/or hypomagnesemia and repeat ECG to confirm exclusion of patient due to prolonged QTc interval\r\n* For patients with heart rate (HR) 60-100 beats per minute (bpm), manual read of QTc is not required\r\n* For patients with a baseline HR < 60 bpm or > 100 bpm, manual read of the QT interval by a cardiologist is required, with Fridericia correction applied to determine QTc (ie, QTcF)
Marked baseline prolongation of QT/QT corrected (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
Corrected QT interval (QTc) > 480 milliseconds as corrected by the Fridericia formula
QTc interval >0.450 seconds (males) or >0.470 (females), or known history of QTc prolongation or Torsade de Pointes (TdP)
A clinically significant electrocardiogram (ECG) abnormality, including a marked Baseline prolonged QT/QTc interval (e.g., a repeated demonstration of a QTc interval >500 milliseconds (msec)).
History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval > 450 milliseconds).
Corrected QT interval duration prolongation
No marked baseline prolongation of QT/QTc interval
Baseline prolongation of the rate-corrected QT interval (QTc; example, repeated demonstration of QTc interval >480 millisecond [ms], or history of congenital, long-QT syndrome, or torsades de pointes).
Have a corrected QT interval >470 milliseconds as calculated be the Fredericia equation.
A clinically significant electrocardiogram (ECG) abnormality (ie, corrected QT interval [QTc] interval greater than 480 msec when electrolyte balance is normal), or a history of risk factors for torsade de pointes, hypokalemia, long QT syndrome, or the use of concomitant medications resulting in a prolongation of QTc interval.
Known history or predisposition to QT interval prolongation
Prolongation of QT/QTc interval
Treatment with medications known to cause corrected QT (QTc) interval prolongation within 7 days of study day 1 is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting
Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/corrected QT (QTc) ([QT interval/corrected QT interval], e.g., a repeated demonstration of a QTc interval > 480 ms), a family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or torsade de pointes (TdP)
Concurrent use of digoxin due to cardiac disease; corrected QT (QTc) interval >= 450 milliseconds in men and >= 470 milliseconds in women within 2 weeks of registration or known history of QTc prolongation or Torsades de Pointes
Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval > 480 milliseconds).
Corrected QT interval (QTc)/QT Fridericia equation (QTf) interval >= 480 milliseconds; unless secondary to pacemaker or bundle branch block
The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB)
Participant has a corrected QT (QTc) interval > 470 ms or known history of QTc prolongation or Torsade de Pointes
Corrected QT (QTc) prolongation, as defined by > 470 milliseconds on ECG
Prolongation of corrected QT interval (QTc) > 480 milliseconds using Bazett’s formula
Corrected QT interval (QTc) > 475 milliseconds
The subject has a baseline corrected QT interval < 500 within 28 days before randomization
Treatment with medications known to cause corrected QT (QTc) interval prolongation within 7 days of study day 1 is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting
Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms)
Clinically significant abnormality on electrocardiogram (ECG). The corrected QT interval (QTc, Fridericia) must be < 470 milliseconds for men and < 490 milliseconds for women (Must be confirmed by at least 2 additional 12-lead ECGs at least 2 minutes apart such that average manually over-read QTcF based on 3 ECGs exceeds stated thresholds)
QTc interval >0.45 seconds
Patients must not have QTc prolongation defined as a QTc interval equal to or greater than 450 milliseconds (msecs)
Concurrent administration of crizotinib and agents that can cause corrected QT (QTc) prolongation is not permitted
Participants with electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc).
Participants with electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc).
Corrected QT interval (QTc) > 470 msec on electrocardiogram (by Bazett’s; average of triplicate recordings at the discretion of the principal investigator [PI]) will exclude patients from entry on study; medications that are known to cause QTc interval prolongation are prohibited for patients entering on trial; patients for whom a given medication that may cause QTc interval prolongation cannot be discontinued, may be eligible at the discretion of the study PI, provided QTc interval criteria is met at enrollment
Has marked prolongation of QTc interval at screening or baseline using the Fridericia method of correction for heart rate
Clinically significant electrocardiogram (ECG) abnormality, including a marked Baseline prolonged QT interval/corrected QT interval ([QT/QTc], example, a repeated demonstration of a QTc interval >500 millisecond [ms]).
Baseline prolongation of the rate-corrected QT interval (QTc) > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes
Patients with current evidence of significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, dilated/hypertrophic or restrictive cardiomyopathy, myocardial infarction (within the past 6 months), unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of medications for rate control for atrial fibrillation is allowed such as calcium channel blockers and beta-blockers, if stable medication for at least last month prior to initiation of MK-2206 treatment and medication not listed as causing torsades de pointes), or evidence of acute ischemia on electrocardiogram (ECG); marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval > 450 msec*; long QT syndrome; the required use of concomitant medication that may cause torsades de pointes or may cause a significant prolongation of the QTc\r\n*Note: Due to difficulties assessing QTc in patients with heart block, they may be eligible if deemed safe by a cardiologist
Must not have QT interval of >470 millisecond.
Corrected QT (QTc) interval >= 500 milliseconds
Concomitant medication that may cause Torsade de Pointes, i.e. prolongation of the QT interval > 500 msec
History of familial long QT syndrome, or use of medications that may cause QTc interval prolongation
Corrected QT (QTc) prolongation with other medications; if the medication can be discontinued and an alternative medication started that does not cause QTc prolongation, the patient would be eligible; if no alternative medication is available and the medication cannot be discontinued for medical reasons, then the patient would not be eligible
Prolongation of corrected QT interval (QTc) > 480 milliseconds (msec)
Patients must not have a marked baseline prolongation of QT/corrected QT (QTc) interval (e.g., demonstration of a QTc interval > 500 milliseconds (ms)
Corrected QT interval (QTc) > 470 milliseconds on baseline electrocardiogram (ECG) (using corrected QT interval using Fridericia [QTcF] or Bazett [QTcB]); if electrolytes are abnormal, they may be corrected and baseline ECG should be repeated
Patients may not currently be taking quinidine, ceritinib, highest risk corrected QT interval (QTc)-prolonging agents, mifepristone, or succinylcholine
Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/QTc ([QT interval/corrected QT interval], e.g., a repeated demonstration of a QTc interval > 500 ms)
EXCLUSION CRITERIA FOR CROSSOVER THERAPY: Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/QTc ([QT interval/corrected QT interval], e.g., a repeated demonstration of a QTc interval > 500 ms)
Current evidence of cardiac arrhythmias defined as corrected QD interval (QTc) >= 480 mm/sec
Patients with a known pathologic prolongation of the corrected QT (QTc)
Corrected QT (QTc) interval within normal range for age
Marked baseline prolongation of QT/corrected QT (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
Previous history of Corrected QT Interval (QTc ) prolongation resulting from medication that required discontinuation of that medication
Patients with corrected QT (QTc) interval > 0.47 seconds
Patients with baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) are ineligible
Patients with current evidence of significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, dilated/hypertrophic or restrictive cardiomyopathy, myocardial infarction (within the past 6 months), unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of medications for rate control for atrial fibrillation is allowed such as calcium channel blockers and beta-blockers, if stable medication for at least last month prior to initiation of romidepsin treatment and medication not listed as causing Torsades de Pointes), or evidence of acute ischemia on electrocardiogram (ECG); marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval > 450 msec*; long QT syndrome; the required use of concomitant medication that may cause Torsades de Pointes or may cause a significant prolongation of the QTc\r\n* Note: due to difficulties assessing QTc in patients with heart block, they may be eligible if deemed safe by a cardiologist; if a patient must take ondansetron as their antiemetic, their QTc may NOT be over 450 (no exception for patients with heart block)
Corrected QT (QTc) prolongation with other medications that required discontinuation of that medication
Prolongation of corrected QT interval (QTc) to >480 ms as demonstrated by a repeated electrocardiogram (ECG) or a clinically significant ECG abnormality, including a marked prolonged QT/QTc interval (eg, a repeated demonstration of a QTc interval >500 ms).