A Study of MEDI-575 in Patients With Advanced Solid Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102400
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : February 6, 2013
MedImmune LLC
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Advanced Solid Malignancies Drug: MEDI-575 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies [ Time Frame: 3 months after last dose of study drug ]
  3. Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 3 months after last dose of study drug ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01102400

Research Site
Nagoya, Aichi, Japan
Research Site
Kashiwa, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Chuo-ku, Tokyo, Japan
Research Site
Sunto-gun, Japan
Sponsors and Collaborators
MedImmune LLC

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT01102400     History of Changes
Other Study ID Numbers: D2840C00001
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: February 2013

Keywords provided by AstraZeneca:
hepatocellular carcinoma

Additional relevant MeSH terms: