Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects
NCT ID: NCT01340040
Last Updated: 2014-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2011-07-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MEDI-573
MEDI-573
MEDI-573
MEDI-573 will be administrated once 7 days in Cohort 1 and 2, and once every 21 days in Cohort 3 as a IV infusion as part of a 21-day treatment cycle.
Interventions
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MEDI-573
MEDI-573 will be administrated once 7 days in Cohort 1 and 2, and once every 21 days in Cohort 3 as a IV infusion as part of a 21-day treatment cycle.
Eligibility Criteria
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Inclusion Criteria
* Histological or cytological confirmation of a solid, malignant tumour excluding lymphoma that is refractory to standard therapies or for which no standard therapies exist
* WHO performance status 0-2 with no deterioration over the previous 2 weeks
Exclusion Criteria
* Inadequate bone marrow reserve or organ function
* Poorly controlled diabetes mellitus as defined by the investigator's assessment and/or glycosylated hemoglobin (HbA1c) reading \> 6.5% within 28 days prior to the first dose of MEDI-573
* History of allergy or reaction to any component of the MEDI-573 formulation or drugs with a similar chemical structure or class to MEDI-573
18 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Bradley, MD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Matsuyama, Ehime, Japan
Countries
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References
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Iguchi H, Nishina T, Nogami N, Kozuki T, Yamagiwa Y, Yagawa K. Phase I dose-escalation study evaluating safety, tolerability and pharmacokinetics of MEDI-573, a dual IGF-I/II neutralizing antibody, in Japanese patients with advanced solid tumours. Invest New Drugs. 2015 Feb;33(1):194-200. doi: 10.1007/s10637-014-0170-x. Epub 2014 Oct 25.
Related Links
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Other Identifiers
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D5621C00006
Identifier Type: -
Identifier Source: org_study_id