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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors and B-cell lymphoma).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc

Criteria

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