Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before registration
Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men and > 470 ms for women at Screening.
Baseline corrected Fridericia QT (QTcF) >= 450 ms (males) or >= 470 ms (females)
Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 milliseconds (ms) for males and > 470 ms for females based on triplicate ECG.
Prolonged Fridericia's corrected QT (QTcF) > 450 ms for men and > 470 ms for women at screening.
Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms Part 2 Only:
The participant has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; note: if initial QTcF is found to be > 500 ms, two additional electrocardiogram (ECGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the participant meets eligibility in this regard
QTc Fridericia (QTcF) >450 ms
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from an electrocardiogram (ECG) using Fridericia’s Correction (QTcF)\r\n* At screening, a single ECG will be obtained on which QTcF must be < 470 ms; in case of clinically significant ECG abnormalities, including a QTcF value > 470 ms, 2 additional 12-lead ECGs should be obtained over a brief period (eg, 30 minutes) to confirm the finding
Subjects must have a 12-lead electrocardiogram (EKG) showing no active ischemia and Fridericia's corrected QT interval (QTcF) less than 480 ms.
Prolongation of corrected QT using Fridericia's formula (QTcF) interval to > 480 ms
Corrected QT interval (QTc) > 500 ms, uncorrectable by managing electrolytes and medications, using the Fridericia's correction (QTcF) formula
Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 7 days before starting study treatment\r\n* Note: if the QTcF is > 500 ms in first electrocardiography (ECG), a total of 3 ECGs should be performed; if the average of these 3 consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) >= 470 ms; abnormality must be confirmed on 3 electrocardiography (ECG)s
Has a mean QTcF prolongation >470 ms for females and >450 ms for males in three successive Screening measurements.
Has history or presence of an abnormal electrocardiogram (ECG) which, in the investigator's opinion, is clinically significant\r\n* Corrected QT Fredericia's formula (QTcF) >= 480 ms or presence of a left bundle branch block (LBBB); if the QRS duration > 120ms, the JTc can be used in place of the QTcF; the JTc must be < 340 ms
Have normal QT interval on electrocardiogram (ECG) evaluation QT corrected Fridericia (QTcF) of =< 450 ms in males or =< 470 ms in females
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiogram (EKG)s separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Baseline corrected QT interval (corrected QT interval by Fridericia's formula [QTcF]) < 480 ms
Subjects with prolongation of corrected QT interval by Fridericia’s method (QTcF) at rest, where the mean QTcF interval is > 450 milliseconds (ms) for males and > 470 ms for females based on triplicate electrocardiogram (ECG)
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before treatment; note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Have normal QT interval corrected (Frederica) (QTcF) interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of ? 450 ms in males or ? 470 ms in females.
Fridericia corrected QT (QTcF) correction unmeasurable or > 450 ms on screening ECG (Note: If a patient has a QTcF interval > 450 ms on screening ECG, the screening ECG may be repeated twice [at least 24 hours apart] for a total of 3 ECGs; the average QTcF from the three screening ECGs must be =< 450 ms in order for the patient to be eligible for the study)
Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is >450 ms for males or >470 ms for females based on triplicate electrocardiograms (ECGs).
A corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before first dose of study treatment; three electrocardiograms (ECGs) must be performed; if the average of these three consecutive results for QTcF is =< 500 msec, the subject meets eligibility in this regard
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Corrected QT interval using Fridericia's formula (QTcF) interval less than or equal to 480 ms (Phase II only)
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Corrected QT for Fridericia (QTcF) interval greater than 500 ms that is not correctable to less than 500 ms such as with cessation of a causative medication, etc
Baseline Fridericia corrected QT (QTcF) > 480 ms; NOTE: this criterion does not apply to patients with a left bundle branch block
History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening QTcF interval >480 ms is excluded. In the event that a single QTcF is >480 ms, the subject may enroll if the average QTcF for the 3 ECGs is < 480ms. For patients with an intraventricular conduction delay (QRS interval >120ms), the JTc interval may be used in place of the QTcF with Sponsor approval. The JTc must be <340 ms if JTc is used in place of the QTcF. Patients with an intraventricular delay due to a left bundle branch block are excluded; Note: QTcF prolongation due to pacemaker may enroll if the JTc is normal.
QTcF interval >470 ms on screening ECG.
Baseline QT interval corrected with Fridericia's method (QTcF) >480 ms NOTE: this criterion does not apply to subjects with a right or left bundle branch block (BBB)
For screening electrocardiographs (ECGs), exclude patients with a Fridericia's corrected QT interval (QTcF) > 480 ms, or JTc > 340 ms for those with an intraventricular conduction delay. If the screening ECG has a QTcF > 480 ms, eligibility can be confirmed if the average of 3 ECGs done 5 minutes apart have an average QTcF < 480 ms
Corrected QT using Fridericia's formula (QTcF) =< 450 ms
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms =< 7 days before the first dose of study treatment
Cardiac ejection fraction >= 50%, and Fridericia's formula corrected QT (QTcF) < 450 ms (male) or < 470 ms (female) on electrocardiogram (ECG) at baseline
DOSE ESCALATION COHORT: History or presence of an abnormal electrocardiogram (ECG) which, in the investigator's opinion, is clinically meaningful; screening corrected QT using Fridericia’s formula (QTcF) interval > 480ms is excluded; subjects with left bundle branch block are excluded
Patients with clinically significant cardiovascular disease; this includes:\r\n* Myocardial infarction or unstable angina within 6 months prior to registration\r\n* New York heart association (NYHA) class II or greater congestive heart failure\r\n* History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication; this does not include asymptomatic atrial fibrillation with controlled ventricular rate\r\n* Any history of congenital long QT syndrome\r\n* The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiogram (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Subjects who have a corrected QT (Fridericia's correction formula [QTcF]) interval > 480 milliseconds (ms) (CTCAE grade > 1) determined by the electrocardiogram (ECG) recorder’s algorithm on the screening ECG
A corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the patient meets eligibility in this regard
Subjects with mean of triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
For participants receiving alectinib: baseline Fridericias corrected QT interval (QTcF) greater than (>) 470 milliseconds (ms) or symptomatic bradycardia.
Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before start of treatment; Note: at baseline (i.e. screening), three ECGs to be obtained within 30 minutes but approximately 2 to 3 minutes apart (i.e. triplicate); if the average of the three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
QTcF values higher than 450 ms at screening
Subjects with mean QTcF interval > 500 ms.
Evidence of QTcF prolongation defined as > 450 ms for males and > 470 ms for females at screening
Fridericia´s Corrected QT interval (QTcF) prolongation > 450 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome). The QTcF will be calculated as the mean of the 3 ECGs taken at screening.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before treatment initiation
Subject with mean Fridericia-corrected QT interval (QTcF) > 450 ms at screening based on central reading.
A screening Fridericia corrected QT interval (QTcF) >= 450 ms (men) or >= 470 ms (women)
Corrected QT interval using Fridericia's formula (QTcF) > 470 msec within 4 weeks of enrollment; if the initial QTcF is found to be > 470 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 470 ms, the subject meets eligibility in this regard
A screening Fridericia corrected QT interval (QTcF) ? 450 ms (men) or ? 470 ms (women).
Baseline corrected QT interval using Fridericia's formula (QTcF) > 480 ms; NOTE: this criterion does not apply to patients with a left bundle branch block
Have normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ?450 ms in males or ?470 ms in females.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 milliseconds (ms) within 28 days before initiation of cabozantinib; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
QT interval corrected for heart rate by Fridericia's formula (QTcF) ? 480ms
Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms (average of triplicate readings) Note: This criterion does not apply to subjects with a right or left bundle branch block (BBB)
Subject has Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
Patient has a corrected QT interval (QTcF) > 500 ms at screening
Corrected QT interval corrected for Fridericia's formula (QTcF) < 450 ms
Corrected QT interval according to Fridericia (QTcF) prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiogram (ECGs) taken at screening.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before initiation of protocol therapy; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization
The patient has a corrected QT interval (corrected QT using Fridericia formula [QTcF]) > 500 ms within 28 days before randomization; if QTcF is >= 500 ms by Bazett formula, this must be confirmed by the Fridericia formula
Normal QT Fridericia-corrected interval (QTcF) ?450 ms for males and ?470 ms for females
QT-interval corrected according to Fridericia's formula (QTcF) ? 450 ms on electrocardiogram (ECG) at Screening
Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) > 450 ms
Subject has QTcF interval > 450 ms on 12-lead ECG at screening.
Normal QT interval corrected (Fridericia) (QTcF) on screening electrocardiogram (ECG) evaluation, defined as QTcF of =< 450 ms in males or =< 470 ms in females
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before day 1 of cycle 1; note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Cardiovascular disorders including:\r\n* Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening\r\n* Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment\r\n* The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard\r\n* Any history of congenital long QT syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** Unstable angina pectoris\r\n** Clinically-significant cardiac arrhythmias\r\n** Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n** Myocardial infarction\r\n** Cardiomyopathy
Cardiac ejection fraction ?50%, and QTcF<450 ms (males) or <470 ms (females) on ECG at Baseline.
Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) >450 ms
Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 ms for males and > 470 ms for females based on triplicate electrocardiogram (ECG).
QTcF corrected with Frederica's or Bazett's formula QTcB >450 ms for males and >470 ms for females on screening ECG.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before enrollment; note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 14 days before week 1 day 1
QTcF >450 ms for males and >470 ms for females on screening ECG
Fridericia's corrected QT (QTcF) prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome); the QTcF will be calculated as the mean of the 3 electrocardiograms (ECGs) taken at screening\r\n* NOTE: The formula used to calculate QTcF can be physician’s choice, but it must be used consistently throughout the study
Prolonged corrected interval between the Q wave and T wave (QTc) by Fridericia's correction factor (QTcF) interval on pre-entry ECG ?450 ms (average of 3 ECG readings done in triplicate);
Baseline Fridericia corrected QT (QTcF) > 480 ms; NOTE: this criterion does not apply to patients with a left bundle branch block
Subject has a QTcF > 480 ms (corrected) in the screening or baseline ECG.
A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation (Fridericia corrected QT interval [QTcF] > 500 ms), a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry; patients with rate-controlled atrial fibrillation/flutter will be allowed on study
A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation (QT interval by Fridericia's correction formula [QTcF] > 500 ms), a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry; patients with rate-controlled atrial fibrillation/flutter will be allowed on study
Has a mean corrected QT interval using Fridericia's Correction Formula (QTcF) prolongation to > 470 ms for females and > 450 ms for males in three successive Screening measurements
Has prolonged corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 milliseconds (ms) based on triplicate electrocardiograms (ECGs)
Baseline Fridericia's correction formula (QTcF) or corrected QT (QTc) > 480 ms.; NOTE: This criterion does not apply to patients with a left bundle branch block
QTcF interval >450 ms for men and >470 ms for women, symptomatic bradycardia <45 beats per minute or other significant ECG abnormalities in the investigator's opinion.