Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible
History of congestive heart failure, arrhythmias, acute coronary syndrome or torsades de pointes
Receiving any medications or substances with risk of Torsades de Pointes; Note: medications or substances on the list “Drugs with Risk of Torsades de Pointes” are prohibited; medications or substances on the list “Drugs with Possible or Conditional Risk of Torsades de Pointes” may be used while on study with extreme caution and careful monitoring
Patients receiving drugs with a known risk of torsades de pointes are not eligible; Note: This list includes the prohibition of grapefruit for 14 days prior to enrollment
Participants taking medications that are known to be associated with torsades de pointes or QT prolongation within 14 days of starting treatment
Taking medications that are known to be associated with torsades de pointes; medications include but are not limited to:\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Erythromycins, clarithromycin\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic\r\n* Chloroquine, domperidone, halofantrine, levomethadyl, pentamidine\r\n* Sparfloxacin, lidoflazine\r\n** Note: participants who have taken a medication associated with torsades de pointes will still be eligible for participation if the medication is discontinued at least 14 days before the initiation of study treatment
Require continued treatment with medications that are known to carry a risk of torsades de pointes.
Medications that have a known risk to prolong the QT interval or induce Torsades de Pointes;
EXPANDED ACCESS COHORT: History of QT syndrome, Brugada syndrome, known history of clinically significant QTc prolongation, or Torsades de Pointes
Patients receiving drugs with a known risk of torsades de pointes are not eligible.
Current treatment with any agent known to cause Torsades de Pointes which cannot be discontinued at least five half-lives or two weeks prior to the first dose of study treatment.
Must have QTc < 460 msec for patients receiving drugs that have a risk of inducing Torsades de Pointes within 7 days prior to registration for protocol therapy
Willingness to discontinue medications known to be associated with risk of Torsades de Pointes such as quinidine, procainamide, disopyramide, amiodarone, erythromycin, clarithromycin, chlorpromazine and haloperidol
Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes (unless these can be changed to acceptable alternatives).
Current treatment with any agent known to cause Torsades de Pointes which cannot be discontinued at least five half-lives or two weeks prior to the first dose of study treatment.
Use of concomitant medications with high risk of causing Torsades des Pointes.
Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes (unless these can be changed to acceptable alternatives).
Receiving QT-prolonging drugs with a risk of causing torsades de pointes (See Appendix E), unless ECG meets inclusion criteria on a stable dose of the drug and with discussion and agreement with the project clinician
Patients with a documented history of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes, or taking drugs that are known to prolong the QT
Receiving any medications or substances with risk of torsades de pointes; NOTE: medications or substances with known risk of torsades de pointes are prohibited; consult pharmacist for review if needed
Concurrent use of any of the following medications during study participation:\r\n* Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib\r\n* Medications which prolong the QTc interval and may predispose to torsades de pointes
Use of medications that are known to prolong the QT interval and/or are associated with a risk of torsades de pointes 7 days prior to first dose
Use of medications that are known to prolong the QT interval and/or are associated with a risk of Torsades de Pointes 7 days prior to first dose
Currently use medications known to cause QT prolongation or Torsades de Pointes.
Are taking medications with a known risk of Torsades de Pointes
Any concomitant medications that are known to be associated with Torsades de Pointes, that in the investigator’s opinion cannot be discontinued, are allowed however, must be monitored closely
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of antimicrobials that are considered to be essential for care of the patient
Patients on medications known to be associated with torsades de pointes
Concomitant use of drugs with a risk of causing torsades de pointes
Patients currently taking drugs that are generally accepted to have a risk of causing torsades de pointes (unless these can be changed to acceptable alternatives)
Have prolonged QTcF interval, or being treated with medications known to be associated with the development of Torsades de Pointes.
Receiving any medications or substances with risk of torsades de pointes; Note: medications or substances on the list \Drugs with Risk of Torsades de Pointes\ are prohibited; medications or substances on the list \Drugs with Possible or Conditional Risk of Torsades de Pointes\ may be used while on study with extreme caution and careful monitoring
AZD1775 should not be given to patients who have a history of Torsades de pointes unless all risk factors that contributed to Torsades have been corrected. AZD1775 has not been studied in patients with ventricular arrhythmias or recent myocardial infarction.
Receiving any medications that prolong the QTc and have a known risk for Torsades de pointes; providers should use caution with drugs with possible increased risk for Torsades de pointes; NOTE: patient will be eligible if they can be taken off these medications prior to initiation of therapy and no less than 4 half-lives of the medication
Any concomitant medications that are known to be associated with Torsades de Pointes or QT elongation
Concomitant medications required on dosing days that increase risk of torsades de pointes
Corrected QT interval (QTc) >= 480 msec and/or receiving any concomitant medications that are associated with a risk of QTc prolongation and/or torsades de pointes; NOTE: these medications should be discontinued or replaced with drugs that do not carry these risks
Receiving a medication with known risk of torsades de pointes; the following medications are specifically prohibited: amiodarone, arsenic trioxide, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, dolasetron, droperidol, erythromycin, halofantrine, haloperidol, ibutilide levomethadyl, mesoridazine, methadone, pentamidine, pimozide, procainamide, quinidine, sotalol, sparfloxacin, and thioridazine; patients should be watched carefully for indications of torsades de pointes, such as syncope; performing additional electrocardiograms (EKGs) on subjects who must take one or more of these medications is not required; however, additional investigations, including EKGs, may be performed as per the treating physician’s judgment
Certain medications that are associated with a risk for QTc prolongation and/or torsades de pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible
Any concomitant medications that are associated with a risk of corrected QT interval (QTc) prolongation and/or torsades de pointes should be discontinued or replaced with drugs that do not carry these risks, if possible; patients who must take medication with a risk of possible risk of torsades de pointes should be watched carefully for symptoms of QTc prolongation, such as syncope; patients with personal or family history of congenital long QTc syndrome are NOT eligible
Concurrent treatment with any medical that prolongs QT interval and may induce torsades de pointes, and which cannot be discontinued at least 2 weeks before treatment with ASTX660. [Applies to Phase 1 only].
Taking any drugs associated with torsades de pointes or known to moderately or severely prolong the QTc(F) interval
Taking any drugs associated with torsades de pointes or known to moderately or severely prolong the QTc(F) interval
Use of medications that have been linked to the occurrence of torsades de pointes
Treatment with medications that are known to carry a risk of Torsades de Pointes.
Medications that have a known risk to prolong the QT interval or induce Torsades de Pointes
Current use of any drugs with a known risk of causing torsades de pointes
That have a known risk to prolong the QT interval or induce Torsades de Pointes.
Concomitant use of QT prolonging agents strongly associated with torsades de pointes is not permitted
Patient is taking a drug with known risk to promote QT prolongation and torsades de pointes
Taking medications that are known to be associated with torsades de pointes
Patients with torsades de pointes within 12 months of study entry
Receiving QT-prolonging drugs with a risk of causing torsades de pointes (TdP), unless ECG meets inclusion criteria on a stable dose of the drug and with discussion and agreement with the project clinician
Participants receiving a medication that has a known risk of QTc prolongation or is associated with torsades de pointes or any prohibited medications, concomitantly or within 14 days (28 days for levomethadyl) of enrollment
That have a known risk to prolong the QT interval or induce Torsades de Pointes.
Medications with a risk of causing Torsades de Pointes are not permitted; although concomitant treatment with corrected QT (QTc) prolonging agents is not strictly prohibited, these agents should be avoided whenever possible and an alternative non-QTc prolonging drug should be substituted if possible
PART B: Concomitant use of medications known to be associated with torsades-de-pointes
Concomitant use of drugs with a risk of causing prolonged QTc and/or torsades de pointes, or patients with a history of risk factors for torsades de pointes (e.g., familial long QT syndrome, heart failure, left ventricular hypertrophy, slow heart rate [< 45 beats per minute])
Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible
Taking medications that are known to be associated with Torsades de Pointes
Receiving medication that prolongs QT interval ,with a risk of causing Torsades de Pointes (TdP), unless ECG meets inclusion criteria while on a stable dose of the medication
Medications that are known to be associated with Torsades de Pointes
Receiving any medications or substances with risk of torsades de pointes; Note: medications or substances on the list “Drugs with Risk of Torsades de Pointes” are prohibited; medications or substances on the list “Drugs with Possible or Conditional Risk of Torsades de Pointes” may be used while on study with extreme caution and careful monitoring
Use of drugs that have a risk of causing QT interval prolongation and/or have a known risk of causing Torsades de Pointes (TdP) before 14 days or the recommended 5 half-life.
Drugs that are known to increase torsades de pointes should be avoided; patients must discontinue these medications prior to enrollment on study; selection of alternate concomitant medications with no or minimal torsades de pointes potential is recommended
Medicines with high probability to cause QT prolongation or torsades de pointes. Subjects on chronic medications in this category may enroll after discussion with the medical monitor if changing these medications are not in the best medical interest of the patient.
Patients with significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, myocardial infarction within the past 6 months, unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of frequency adjusting medication for atrial fibrillation is allowed, if stable medication for at least last month prior to initiation of belinostat treatment and medication not listed as causing Torsades de Pointes), or evidence of acute ischemia on electrocardiogram (ECG); marked baseline prolongation of QT/corrected QT (QTc) interval, e.g., repeated demonstration of a QTc interval > 450 msec; long QT syndrome; concomitant use of drugs known to prolong the QT interval and/or cause Torsades de Pointes is not allowed during the study or within 2 weeks of study entry; these drugs should also be avoided for up to 4 weeks following discontinuation of study treatment; drugs that may be associated with Torsades de Pointes but lack substantial evidence will be allowed at the discretion of the PI (although it is preferable to substitute an alternate medication), and patients will be closely monitored
Treatment with medications that are known to carry a risk of Torsades de Pointes
Patient is taking a drug with a risk to promote QT prolongation and Torsades de Pointes.
Concurrent medications associated with a risk of corrected QT (QTc) prolongation and/or torsades de pointes are not allowed; those medications listed as reported but lacking substantial evidence for causing QTc prolongation and torsades de pointes will be allowed, although if an alternative medication can be substituted, that would be preferable; for this study, a baseline electrocardiogram (EKG) will be performed and will be repeated during cycle 1 and then every 3 cycles while on treatment
Evidence of QT prolongation and/or torsades de pointes (TdP) on electrocardiogram (EKG)
Subject has unavoidable concomitant treatment with any drug known for causing Torsades de Pointes.
Patients on medications with the potential for significant interaction with orteronel; patients may be rescreened and considered eligible for this protocol 7 days after they discontinue these medications; specific considerations include:\r\n* Medications with a known risk for causing torsades des pointes\r\n* Medications with a potential for increasing the QTc\r\n* Medications should be reviewed with attention to:\r\n** Beta-blockers \r\n** Diuretics \r\n** Anti-coagulants\r\n** These medications will not exclude patients from study, but should be brought to the attention of both the treating physician and PI with consideration for closer monitoring, to be determined clinically
Participants taking medications known to have a significant risk of causing QTc prolongation and Torsades de Pointes
Subjects taking medications known to increase risk of Torsades de Pointes
Receiving any medication that has documented data or is generally accepted as having increased risk of QT prolongation and/or Torsades de Pointes
Taking medications known to increase risk of Torsades De Pointes (an abnormal heart rhythm)
Taking medications known to increase risk of Torsades De Pointes
Concurrent medication that may cause QTc prolongation or induce Torsades de Pointes
Patients taking medications known to cause prolongation of the QT interval and associated with torsades de points; patients receiving drugs that are “possibly” or have a “conditional” risk may be entered
Patients currently taking drugs that are generally accepted to have a risk of causing torsades de pointes (unless these can be changed to acceptable alternatives)
Any concomitant medications that are associated with a risk of corrected QT (QTc) prolongation and/or Torsades de Pointes should be discontinued or replaced with drugs that do not carry these risks, if possible; patients who must take medication with a possible risk of Torsades de Pointes should be watched carefully for symptoms of QTc prolongation, such as syncope; patients with personal or family history of congenital long QTc syndrome are NOT eligible
Receiving any medications that prolong the corrected QT (QTc) and have a known risk for Torsades de pointes; note: providers should use caution with drugs with possible increased risk for Torsades de pointes; patient will be eligible if they can be taken off these medications prior to initiation of therapy and no less than 4 half-life of the medication
Patient is using drugs (or has medical conditions) that are generally accepted to have a risk of causing torsades de pointes (TdP) patients who have discontinued any of these medications must have a wash-out period of at least 5 days or 5 half-lives of the drug (whichever is greater) prior to the first dose of AC480IV
Subjects taking any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes are not eligible if QTc ? 460 msec.
Treatment with medications that are known to carry a risk of Torsades de Pointes
Concurrent medications associated with a known risk of corrected QT interval (QTc) prolongation and/or Torsades de Pointes are not allowed within 2 weeks of initiation of study treatment; those medications listed as a possible risk for causing QTc prolongation and Torsades de Pointes will be allowed, although if an alternative medication can be substituted, that would be preferable; granisetron is an acceptable antiemetic on this study, but if a patient must take ondansetron, they may NOT take any other concomitant agents which might impact their QTc
Any concurrent medication with a known risk of inducing Torsades de Pointes, that in the investigator’s opinion cannot be discontinued
Treatment with QT-prolonging drugs with a risk of causing torsades de pointes (TdP. Participants taking drugs with a possible or conditional risk of QT prolongation or drugs that are to be avoided by participants with congenital long QT syndrome may be considered if on a stable dose, pending discussion and agreement between the investigator and the sponsor.