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

Advanced Solid Malignancies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102400
• Other study ID #: D2840C00001
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2010
• Last updated: February 5, 2013
• Start date: March 2010
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Research Site	Chuo-ku	Tokyo
Japan	Research Site	Kashiwa	Chiba
Japan	Research Site	Matsuyama	Ehime
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Sunto-gun

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	MedImmune LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign		30 days after the last dose of MEDI-575	Yes
Secondary	Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion		30 days after last dose of study drug	No
Secondary	To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies		3 months after last dose of study drug	No
Secondary	Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST)		3 months after last dose of study drug	No