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

This study has been completed.
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01102400
First received: March 31, 2010
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Advanced Solid Malignancies
 Drug: MEDI-575
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies [ Time Frame: 3 months after last dose of study drug ] [ Designated as safety issue: No ]
  • Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 3 months after last dose of study drug ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: March 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102400

Locations
Japan
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
AstraZeneca
MedImmune LLC
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01102400     History of Changes
Other Study ID Numbers: D2840C00001
Study First Received: March 31, 2010
Last Updated: February 5, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
cancer
tumor
hepatocellular carcinoma

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013