Status:
COMPLETED
Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Solid Tumor
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).
Detailed Description
This study will be conducted using a traditional 3 + 3 dose escalation study design. Enrollment of at least 3 subjects is planned for each dosing cohort. The decision to expand a cohort or dose escala...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01401504
Start Date
May 1 2011
End Date
January 1 2014
Last Update
June 11 2014
Active Locations (1)
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1
Kansai, Japan