A Study of MEDI-575 in Patients With Advanced Solid Malignancies
- Registration Number
- NCT01102400
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Having advanced solid malignancy for which no curative or standard therapies exist
- Karnofsky performance status of ≥60
- Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part)
Exclusion Criteria
- Inadequate bone marrow reserve or organ function
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures
- History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MEDI-575 -
- Primary Outcome Measures
Name Time Method Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign 30 days after the last dose of MEDI-575
- Secondary Outcome Measures
Name Time Method Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST) 3 months after last dose of study drug Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion 30 days after last dose of study drug To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies 3 months after last dose of study drug
Trial Locations
- Locations (1)
Research Site
🇯🇵Sunto-gun, Japan