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

Study drug

MEDI-573

Sex

All

Actual Enrollment

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

Collaborators

MedImmune

Inclusion and exclusion criteria

Location

Research Site

Matsuyama, Ehime, Japan

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.

Documents available

Protocol Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

001-800-236-9933

clinicaltrialenquiries@medimmune.com

Investigators

Principal Investigator

Edward Bradley