A Study of MEDI-575 in Patients With Advanced Solid Malignancies
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
1 other identifier
interventional
22
1 country
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2010
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 31, 2010
CompletedFirst Posted
Study publicly available on registry
April 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 6, 2013
February 1, 2013
2.7 years
March 31, 2010
February 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST)
3 months after last dose of study drug
Study Arms (1)
1
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- MedImmune LLCcollaborator
Study Sites (5)
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Kashiwa, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Chuo-ku, Tokyo, Japan
Research Site
Sunto-gun, Japan
Related Publications (1)
Murakami H, Ikeda M, Okusaka T, Inaba Y, Iguchi H, Yagawa K, Yamamoto N. A Phase I study of MEDI-575, a PDGFRalpha monoclonal antibody, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):631-9. doi: 10.1007/s00280-015-2832-6. Epub 2015 Jul 30.
PMID: 26223436DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2010
First Posted
April 13, 2010
Study Start
March 1, 2010
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 6, 2013
Record last verified: 2013-02