NCT00977210已完成1 期
A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors.
Mateon Therapeutics1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年7月最近更新:
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
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions.
研究概览
简要总结
The purpose of this study is to establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly infusions to patients with advanced solid tumors.
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
- •Histologically proven cancer.
- •Written informed consent.
- •Age >/= 18 years.
- •Life expectancy of at least 12 weeks.
- •World Health Organization (WHO) performance status of 0 or
- •Adequate Hematological and biochemical indices to support investigational therapy.
- •All women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
- •WOCBP and fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days after the last dose of study medication.
- •Measurable and evaluable disease.
- •All toxic manifestations of previous treatment must have resolved.
- •Able to undergo MRI scanning.
排除标准
- •Radiotherapy, endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) prior to treatment.
- •Pregnant and lactating women.
- •Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
- •Patients which have active uncontrolled infections.
- •Patients with any other condition that in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
- •Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- •Previous or ongoing cardiac conditions.
- •Uncontrolled hypertension.
- •Patients taking any drug known to prolong the QTc interval.
- •Patients who have had any ischaemic or vascular damage from previous radiotherapy.
- •Patients taking warfarin or heparin.
- •Patients taking naproxen.
- •Patients taking supplements or multivitamins containing vitamin C.
- •Patients should not be taking any other investigational drug for the duration of the study.
- •Patients with brain metastases or neurological tissue involvement of the spinal column.
研究组 & 干预措施
OXi4503
Experimental
干预措施: OXi4503 (Drug)
结局指标
主要结局
To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions.
时间窗: 4 weeks
次要结局
- To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503.(4 weeks)
研究者
研究点 (1)
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