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

AstraZeneca10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Advanced Solid Malignancies

Interventions

MEDI-573DRUG

MEDI-573 will be administrated once 7 days in Cohort 1 and 2, and once every 21 days in Cohort 3 as a IV infusion as part of a 21-day treatment cycle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Matsuyama, Ehime, Japan

Outcomes

Primary Outcomes

Number of participants with adverse events (based on CTCAE version 4.0), laboratory values, vital sign measurements, ECG, Physical Examination

The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

Time frame: All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment.

Secondary Outcomes

Immunogenicity of MEDI-573 (by measuring anti-MEDI-573 antibodies)

The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

Time frame: For Cohorts 1, 2 and 3:day 1 (pre-dose) of every cycle; 30 days after the last dose; 3 months after the last dose

Anti-tumor activity of MEDI-573 using Response Evaluation Criteria in Solid Tumors(RECIST)

subjects who discontinue the study treatment for reasons other than disease progression or initiation of alternative anticancer therapy will undergo tumor assessment 3 months after the last dose of MEDI-573). The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

Time frame: Tumor assessment by RECIST 1.1 every 2 cycles

Pharmacokinetics, - Cmax

The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

Time frame: For Cohorts 1, 2 and 3:Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.

Pharmacokinetics,- Cmax at steady state (Cmax, ss)

The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

Time frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.