Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma)

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor or B-cell lymphoma and meets at least 1 of the following criteria:

  • Disease progression despite standard therapies
  • No standard therapies are available or such therapies are not anticipated to result in a durable response
  • Standard therapies are considered unsuitable or have been refused
• Able to take oral medications
• Life expectancy > 12 weeks
• For the expansion cohort of the study, all subjects must be confirmed to be positive for ALK gene abnormalities
• Subjects with stable brain metastasis will be allowed

Exclusion Criteria:

• Active central nervous system (CNS) metastases or leptomeningeal involvement as assessed through medical history review and physical examination (dose escalation subjects only)
• Known history of a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
• Known hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection
• Cardiac arrhythmias > Grade 1 using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.03
• Class 3 or 4 New York Heart Association congestive heart failure, acute coronary syndrome, myocardial infarction or cerebrovascular accident within 6 months prior to Cycle 1, Day 1
• Inadequate bone marrow, renal, and/or hepatic function
• Confirmed active peptic ulcer disease or history of gastrointestinal bleeding within the past 3 months
• Known history of long QT syndrome