Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Cancer; Advanced Solid Malignancies

Treatments: Drug: MEDI-573

Study type: Interventional

Funder types: Industry

Identifiers

NCT01340040

D5621C00006

Details and patient eligibility

About

The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in Japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese men or women at least 20 years of age
• Histological or cytological confirmation of a solid, malignant tumour excluding lymphoma that is refractory to standard therapies or for which no standard therapies exist
• WHO performance status 0-2 with no deterioration over the previous 2 weeks

Exclusion criteria

• Previous therapy with medication against IGF (ie, monoclonal antibodies with IGF-1R or IGF-targeting tyrosine kinase inhibitors)
• Inadequate bone marrow reserve or organ function
• Poorly controlled diabetes mellitus as defined by the investigator's assessment and/or glycosylated hemoglobin (HbA1c) reading > 6.5% within 28 days prior to the first dose of MEDI-573
• History of allergy or reaction to any component of the MEDI-573 formulation or drugs with a similar chemical structure or class to MEDI-573

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MEDI-573

Experimental group

Description:

MEDI-573

Treatment:

Drug: MEDI-573