NCT01132625已完成1 期
A Japanese Phase I, Multi-center, Open-label, Study of AUY922 Administered Intravenously on a Once Weekly Schedule in Adult 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
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- establish maximum tolerate dose (safety and tolerability)
研究概览
简要总结
This study will characterize the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of AUY922 in adult patients with advanced solid malignancies in Japan.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced malignant solid tumors
- •ECOG Performance Status of ≤ 2
- •Patients must have the following laboratory values:
- •Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 8.5 g/dl, Platelets (plt) ≥ 100 x 109/L
- •Potassium, Calcium, Magnesium, Phosphorus within normal limits or correctable with supplements
- •AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN)
- •Serum bilirubin ≤ 1.5 x ULN, Serum albumin > 2.5g/dl, Serum creatinine≤ 1.5 x ULN or 24-hour clearance ≥ 50 ml/min
- •Able to sign informed consent and to comply with the protocol
排除标准
- •Patients with brain metastasis.
- •Prior treatment with any HSP90 or HDAC inhibitor compound.
- •Treatment with therapeutic doses of coumarin anticoagulants.
- •Pregnant and lactating women.
- •Severe and/or uncontrolled acute or chronic liver disease
- •Severe and/or uncontrolled acute or chronic renal disease
- •Chronically significant heart disease
- •History (or family history) of long QT syndrome. QTc ≥ 450 msec on screening ECG, ischemic heart disease, heart fail, ECG abnormalities, atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes.
- •Patients who are currently receiving treatment with any medication which has a relative risk or prolonging the QTcF interval or inducing Torsades de Pointes
- •Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g Gilbert's syndrome).
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AUY922
Experimental
干预措施: AUY922 (Drug)
结局指标
主要结局
establish maximum tolerate dose (safety and tolerability)
时间窗: about 3 years
次要结局
- Efficacy assessed by RECIST(about 4 years)
- Safety assessed by type, frequency and severity of adverse events(about 4 years)
- Pharmacodynamic assessed by blood and tumor biomarkers at baseline and post AUY922(about 4 years)
- Pharmacokinetic assessed by Cmax, Tmax, AUC(about 3 years)
研究者
研究点 (1)
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