Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).

• 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

• Patient 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

• Life expectancy > 12 weeks

• Able to be hospitalized from 1 day prior to the initial dosing until day 15 of the dosing, and from day 27 until day 29 of the dosing

Exclusion Criteria:

• Patient exhibits persistent subjective and objective findings of toxicity ≥ Grade 2 (CTCAE v4.0-JCOG) from the previous cancer treatment with antitumor effect (except of alopecias)

• Received previous treatment with antitumor effect within 21 days prior to the scheduled initial dosing

• Patient had a major surgical procedure within 21 days prior to the scheduled initial dosing or a major surgical procedure scheduled during the course of the study

• Use of an investigational drug or device within 21 days prior to the scheduled initial dosing

• Use of blood transfusion or hematopoietic growth factors within 14 days prior to the scheduled initial dosing

• A positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)

• Known history of a positive test for human immunodeficiency virus (HIV) infection

• Patient has central nervous system (CNS) or leptomeningeal involvement with clinical symptoms