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NCT Number: NCT01102400

A Study 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).

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Key information

Conditions

Advanced Solid Malignancies Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDI-575

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • MedImmune LLC

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2010
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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