- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01102400
A Study of MEDI-575 in Patients With Advanced Solid Malignancies
February 5, 2013 updated by: AstraZeneca
A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sunto-gun, Japan
- Research Site
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Aichi
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Nagoya, Aichi, Japan
- Research Site
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Chiba
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Kashiwa, Chiba, Japan
- Research Site
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Ehime
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Matsuyama, Ehime, Japan
- Research Site
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Tokyo
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Chuo-ku, Tokyo, Japan
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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MEDI-575 will be administered weekly or every 3 weeks as IV infusion as part of a 21-day treatment cycle.
One or two doses will be selected for expansion part
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign
Time Frame: 30 days after the last dose of MEDI-575
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30 days after the last dose of MEDI-575
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion
Time Frame: 30 days after last dose of study drug
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30 days after last dose of study drug
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To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies
Time Frame: 3 months after last dose of study drug
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3 months after last dose of study drug
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Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: 3 months after last dose of study drug
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3 months after last dose of study drug
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
March 31, 2010
First Submitted That Met QC Criteria
April 12, 2010
First Posted (Estimate)
April 13, 2010
Study Record Updates
Last Update Posted (Estimate)
February 6, 2013
Last Update Submitted That Met QC Criteria
February 5, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2840C00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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