Safety and Tolerability Study of INNO-406 to Treat Chronic Myeloid Leukemia or Acute Lymphocytic Leukemia

The purpose of this study is to determine the safety, tolerability and pharmacokinetic profile of INNO-406 when administered as a daily oral agent in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.

Inclusion criteria

• Have a confirmed diagnosis of Ph+ ALL or CML in chronic, accelerated, or blastic phases that are either resistant to or intolerant of imatinib therapy.
• Be ≥18 years old.
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
• Have an estimated life expectancy of ≥12 weeks.
• Be male or non-pregnant, non-lactating female. Patients who are fertile must agree to use an effective barrier method of contraception while on therapy and for 90 days following discontinuation of study drug.
• Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
• Have acceptable pre-treatment clinical laboratory results.

Exclusion criteria

• Have received chemotherapy ≤1 week from the start of therapy, with the exception of hydroxyurea and corticosteroids.
• Have received imatinib ≤3 days prior to enrollment or have not recovered from side effects of imatinib therapy.
• Have impaired cardiac function.
• Have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
• Have clinically significant acute or chronic liver or renal disease considered unrelated to tumor.
• Have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection).
• Are pregnant or lactating.
• Have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
• Have not recovered from acute toxicity of all previous therapy prior to enrollment.
• Have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol.
• Have a history of another primary malignancy that is currently clinically significant or requires active intervention.