Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects
- Registration Number
- NCT01340040
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MEDI-573 MEDI-573 MEDI-573
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (based on CTCAE version 4.0), laboratory values, vital sign measurements, ECG, Physical Examination All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics, - Cmax For Cohorts 1, 2 and 3:Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacokinetics - total clearance and terminal phase (Vz) of MEDI-573 For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacokinetics, - terminal elimination rate constant (λz) For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacokinetics - (AUC(0-t)) For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Immunogenicity of MEDI-573 (by measuring anti-MEDI-573 antibodies) 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 The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacokinetics - time to maximum concentration (tmax) For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Anti-tumor activity of MEDI-573 using Response Evaluation Criteria in Solid Tumors(RECIST) Tumor assessment by RECIST 1.1 every 2 cycles 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.
Pharmacokinetics,- Cmax at steady state (Cmax, ss) For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacodynamics: - Insulin-like growth factor (IGF)-I and IGF-II on circulating plasma levels of MEDI-573 For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Trial Locations
- Locations (1)
Research Site
🇯🇵Matsuyama, Ehime, Japan