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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014