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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Malignancies

Treatments: Drug: MEDI-575

Study type: Interventional

Funder types: Industry

Identifiers

NCT01102400

D2840C00001

Details and patient eligibility

About

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).

Enrollment: 22 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

1

Experimental group

Treatment:

Drug: MEDI-575