A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL)

Inclusion Criteria

• Patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, as follows:
• All patients must have screening bone marrow (BM) cytogenetics with conventional banding performed within 42 days prior to beginning treatment.
• Examination of at least 20 metaphases is required in patients in CP. If less than 20 metaphases are examined, the BM aspirate must be repeated.
• Adequate BM aspirate with differential cell counts is required in patients with AP, BP, or Ph+ ALL. If an adequate aspirate is not obtained, the aspirate must be repeated.
• Be previously treated with and resistant, or intolerant, as defined in the protocol, to either dasatinib or nilotinib for CML or at least one TKI for Ph+ ALL, regardless of whether dasatinib or nilotinib or the prior TKI were used to treat newly diagnosed or resistant patients.
• Must be ≥ 18 years old.
• Provide written informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Minimum life expectancy of 3 months or more.
• Adequate renal function defined as serum creatinine grade 1 by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 [NCI CTCAE v.4.0]) from adverse events (AEs) (except alopecia) due to agents previously administered.
• Received other therapies as follows:
• For CP and AP patients, received interferon, cytarabine, or immunotherapy within 14 days, or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib.
• For BP patients, received chemotherapy within 7 days prior to the first dose of ponatinib. Otherwise, 2a applies.
• For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of ponatinib and other chemotherapy within 7 days prior to the first dose of ponatinib. Otherwise, 2a applies.
• All patients are excluded if they have not recovered (> grade 1 by NCI CTCAE v.4.0) from AEs (except alopecia) due to agents previously administered.
• Underwent autologous or allogeneic stem cell transplant 450 mg/dL).
• Have malabsorption syndrome or other gastrointestinal illness that could affect absorption of orally administered ponatinib.
• Have been diagnosed with another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ, or controlled prostate cancer, which are allowed within 3 years).
• Are pregnant or lactating. Women of childbearing potential must agree to an effective contraception from the time of signing the informed consent through the Follow-up Visit, approximately 30 days after last dose of ponatinib.
• Underwent major surgery (with the exception of minor surgical procedures, such as catheter placement or BM biopsy) within 14 days prior to first dose of ponatinib.
• Have ongoing or active infection (including known history of human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV]). Testing for these viruses is not required in the absence of history.
• Suffer from any condition or illness that, in the opinion of the Investigator or the Medical Monitor, would compromise patients safety or interfere with the evaluation of the safety of the study drug.