dose-escalation study to assess safety, tolerability and pharmacokinetics of MEDI-573 in Japanese subjects
Study identifier:D5621C00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Japanese Subjects with Advanced Solid Tumours Refractory to Standard Therapy or for Which No Standard Therapy Exists
Medical condition
cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI-573
Sex
All
Actual Enrollment
10
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 01 Jul 2011
Primary Completion Date: 01 Apr 2012
Study Completion Date: 01 May 2012
Study design
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
MedImmune
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI-573 MEDI-573 | Drug: 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. |
Contacts
Investigators
Principal Investigator
Edward Bradley
MedImmune
