NCT01340040已完成1 期
A Phase 1, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Japanese Subjects With Advanced Solid Tumours Refractory to Standard Therapy or for Which No Standard Therapy Exists
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (based on CTCAE version 4.0), laboratory values, vital sign measurements, ECG, Physical Examination
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MEDI-573
Experimental
MEDI-573
干预措施: MEDI-573 (Drug)
结局指标
主要结局
Number of participants with adverse events (based on CTCAE version 4.0), laboratory values, vital sign measurements, ECG, Physical Examination
时间窗: 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.
次要结局
- Pharmacokinetics, - Cmax(For Cohorts 1, 2 and 3:Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.)
- 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.)
- 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.)
- Pharmacokinetics - (AUC(0-t))(For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.)
- 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)
- 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.)
- Anti-tumor activity of MEDI-573 using Response Evaluation Criteria in Solid Tumors(RECIST)(Tumor assessment by RECIST 1.1 every 2 cycles)
- 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.)
- 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.)
研究者
研究点 (1)
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