NCT01026402已完成1 期
A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTor Kinase Inhibitor AZD2014 Administered Orally to Patients With Advanced Solid Malignancies
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
- 172
- 试验地点
- 1
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug. The study will also assess the blood levels and action of AZD2014 in the body over a period of time and will indicate whether the drug has an effect on the types of cancer the patients have.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 150 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmation of a solid, malignant tumour that is refractory to standard therapies or for which no standard therapies exist
- •At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
- •World Health Organisation performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
排除标准
- •Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks prior to first dose of study drug
- •Patients with abnormal fasting glucose, type I or uncontrolled type II diabetes
- •Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions
研究组 & 干预措施
AZD2014
Experimental
AZD2014 dose escalation phase in Part A and expansion phase in Part B.
干预措施: AZD2014 (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLTs)
时间窗: Up to 21 days from first multiple dose
Maximum Tolerated Dose (MTD) was determined by testing various doses and schedules of AZD2014 in cohorts of 3-6 evaluable patients. MTD reflects the highest dose of drug at each schedule that did not cause a DLT in \>1 patient
次要结局
- Maximum Concentration (Cmax) Single Dose(Following Single Dose up to 12, 24 or 48 hours post dose)
- Partial Metabolic Response (PMR), Cycle 1(Cycle 1 Day 8)
- Area Under the Curve (AUC) Single Dose(Following Single Dose up to 12, 24 or 48 hours post dose)
- Maximum Concentration (Cmax) at Steady State(Multiple dosing to steady state (up to 12 or 48 hours post dose))
- Urine PK - Fraction Dose Excreted (fe(0-12)) at Steady State(Pre dose through to 24 hours post dose)
- Urine PK - Renal Clearance (Renal CL) at Steady State(Pre dose through to 24 hours post dose)
- Percent Change From Baseline in p4EBP1 at 2 Hours Post Dose(predose and 2 hours after a single dose)
- Complete Metabolic Response (CMR), Cycle 1(Cycle 1 Day 8)
- Complete Metabolic Response (CMR), Cycle 2(Cycle 2 Day 8)
- Best Objective Response(Assessed every 8 weeks until progression or withdrawal, whichever came first, estimated to be up to 4 months)
- Partial Metabolic Response (PMR), Cycle 2(Cycle 2 Day 8)
- Area Under the Curve (AUC) at Steady State(Multiple dosing to steady state (up to 12 or 48 hours post dose))
- Urine PK - Fraction Dose Excreted (fe(0-12)) Single Dose(Pre dose through to 12 hours post dose)
- Urine PK - Renal Clearance (Renal CL) Single Dose(Pre dose through to 24 hours post dose)
- Percent Change From Baseline in pAKT (S473) in Platelet Rich Plasma (PRP) at 2 Hours Post Dose(predose and 2 hours after a single dose)
研究者
研究点 (1)
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