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

Completed · Phase 1

Conditions studied: Advanced Malignancies, Positive for Anaplastic Lymphoma Kinase, Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS, Solid Tumor, B-Cell Lymphoma

In brief

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

Key facts

Study ID

NCT01284192

Run by

Astellas Pharma Inc

People needed

46

Starts

2010-12-01

Expected to finish

2016-03-01

Last updated by the study team

2016-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site US160 — Orange, California, United States
• Site US184 — Sacramento, California, United States
• Site US11 — Chicago, Illinois, United States
• Site US2688 — Detroit, Michigan, United States
• Site US2492 — Houston, Texas, United States
• Site US1905 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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