NCT01361529Unknown1 期
Phase 1 Study of FLP Injection on Tumor Patients
Acea Bio (Hangzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- adverse effect assessment
研究概览
简要总结
The purpose of this study is to determine the tolerance and maximum tolerated dose (MTD) for FLP Injection with multiple dose in tumor patients.
详细描述
To determine the tolerance and MTD for FLP Injection with multiple dose in tumor patients.
To test clinical pharmacokinetics (PK) and PK parameter
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged from 18 to 70 years old, male or female;
- •histologically or cytologically proven advanced malignant solid tumors;
- •cancer patients after conventional treatment failure and lack of effective treatment, or patients refusing effective treatment of existing practices;
- •patients receiving the last treatment (chemotherapy, radiotherapy, biological therapy, targeted therapy, or other study drugs) for at least 4 weeks;
- •expected survival time>3 months;
- •ECOG score 0-1
排除标准
- •viral activity in patients
- •allergic to drugs or excipients;
- •hypersensitivity to paclitaxel injection patients;
- •HIV antibody positive, or suffering from other acquired and congenital immune deficiency disease, or history of organ transplantation;
- •neutrophil count <1.5 × 109 / L, platelets <100 × 109 / L, or hemoglobin <90g / L;
- •normal serum creatinine higher than 1.5 times the upper limit of reference range or the muscle of liver clearance <60ml/min;
- •no case of liver ALT or AST> 2.5 times the upper limit of normal, or liver metastases than normal under the ALT or AST 5 times upper limit of reference range;
- •fever or body temperature above 38 ℃ can be clinically significant impact on clinical trials of active infection;
- •medications failed to control hypertension (systolic pressure is over 160 mmHg or diastolic pressure over 100mmHg);
- •significant cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome), or clinically significant arrhythmias (such as long QT syndrome, Corrected QTc not be measured or ≧ 480 ms);
- •calcium, potassium, magnesium ions below the lower limit of normal;
- •> I-level peripheral neuropathy
- •Prior to the toxicity of anticancer therapy has not been restored or not from the surgery before full recovery;
- •bone metastases for the primary lesion of palliative radiotherapy;
- •any clinical problems can not control (such as the serious mental, neurological, cardiovascular, respiratory and other diseases);
- •a tumor metastasis, or a variety of mental disorders center; no history of asthma;
- •pregnancy or breast-feeding women
研究组 & 干预措施
safty test
Experimental
FLP,dose escalation,MTD
干预措施: FLP,dose escalation,MTD (Drug)
结局指标
主要结局
adverse effect assessment
时间窗: 21 days
to evlauate the symptom of adverse effect and the number of participates with adverse effect
次要结局
未报告次要终点
研究者
研究点 (1)
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