A Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML

Exclusion Criteria

• •Patients in complete molecular remission (CMR) on a TKI.
• •Patients who have failed nilotinib or not tolerated nilotinib in the past
• •Certain cardiovascular disorders
• •Currently receiving treatment with strong CYP3A4 inhibitors which cannot be discontinued prior to starting study drug
• •Actively receiving herbal medicines that are strong CYP3A4 inhibitors and/or inducers and treatment cannot be discontinued prior to starting study drug
• •Currently receiving treatment with any medications that have the potential to prolong the QT interval that cannot be discontinued prior to starting study drug
• •Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the drug
• •Acute or chronic pancreatic disease within the last year
• •Cytopathologically confirmed Central Nervous System (CNS) infiltration
• •Another primary malignancy that requires systemic chemotherapy or radiation
• •Acute or chronic liver disease or severe renal disease considered unrelated to the cancer
• •History of significant congenital or acquired bleeding disorder unrelated to cancer
• •Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered from prior surgery
• •Past treatment with ruxolitinib
• •Treatment with other investigational agent within 30 days of Day 1
• •Inability to grant consent or history of non-compliance to medical regimens
• •Women who are breastfeeding
• •Women of child-bearing potential, unless they are using highly effective contraception