Expanded Access Program of Ponatinib

Exclusion Criteria

• •1. Are eligible for an ongoing and accessible clinical trial of ponatinib
• •2. Have not adequately recovered from AEs due to agents previously administered
• •3. Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy.
• •4. Have previously been treated with ponatinib.
• •5. Have significant or active cardiovascular disease, specifically including, but not restricted to:
• •* Myocardial infarction within 3 months prior to first dose of ponatinib,
• •* History of clinically significant atrial arrhythmia or any ventricular arrhythmia,
• •* Unstable angina within 3 months prior to first dose of ponatinib,
• •* Congestive heart failure within 3 months prior to first dose of ponatinib.
• •6. Have abnormal QTcF (\> 450 ms for males or \> 470 ms for females)
• •7. Have a significant bleeding disorder unrelated to CML or Ph+ ALL.
• •8. Have a history of pancreatitis or alcohol abuse
• •9. Have elevated amylase or lipase (\> 1.5 x ULN for institution) at entry.
• •10. Have inadequate hepatic function or any of the following:
• •* Total bilirubin \> 1.5 x ULN for institution at entry
• •* Alanine aminotransferase and aspartate aminotransferase \> 2.5 x ULN for institution at entry
• •* Prothrombin time \>1.5 x ULN for institution at entry
• •11. Have inadequate renal function or serum creatinine \> 2.5 x ULN for institution at entry
• •12. Have uncontrolled hypertriglyceridemia or triglycerides \> 450 mg/dL at entry.
• •13. Have malabsorption syndrome or other gastrointestinal illness that could affect absorption of orally administered ponatinib.
• •14. Women who are pregnant or lactating.
• •15. Underwent major surgery within 14 days prior to the first dose of ponatinib.
• •16. Have ongoing or active infection (including known history of human immunodeficiency virus \[HIV\], hepatitis B virus \[HBV\], or hepatitis C virus \[HCV\]).
• •17. Suffer from any condition or illness that, in the opinion of the Investigator would compromise patient safety or interfere with the evaluation of the safety of the study drug.