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

Status

Completed

Conditions

Intervention / Treatment

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

  • Japan
      • Sunto-gun, Japan
        • Research Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Research Site
    • Chiba
      • Kashiwa, Chiba, Japan
        • Research Site
    • Ehime
      • Matsuyama, Ehime, Japan
        • Research Site
    • Tokyo
      • Chuo-ku, Tokyo, Japan
        • Research Site

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
Drug: MEDI-575
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

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
30 days after the last dose of MEDI-575

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
30 days after last dose of study drug
To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies
Time Frame: 3 months after last dose of study drug
3 months after last dose of study drug
Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: 3 months after last dose of study drug
3 months after last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

MedImmune LLC

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.

General Publications

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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