NCT00261391已完成1 期
Phase I Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Marimastat in Patients With Disabling Malformations and No Other Treatment Options
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- History
研究概览
简要总结
3 patients were enrolled in each of 3 study cohorts. There three cohorts were given differing, incrementally larger doses of this phase I drug. The same safety measures are being obtained on all patients. Efficacy measures were individualized as enrolllees do not have the same underlying vascular anomaly. The study is structured to include a 24 month drug-phase and a 24 month follow-up phase. The study is now closed to enrollment.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with vascular malformation causing risk of one or more of the following based on unanimous assessment of designated physicians in the multidisciplinary Vascular Anomalies Team.
- •airway/respiratory/visual/auditory/neurologic compromise;
- •high output cardiac failure;
- •life-threatening or disabling hemorrhage(cutaneous/GI/intracranial/ parenchymal/cavitary);
- •skeletal distortion/destruction/erosion;
- •life-threatening or disabling soft tissue distortion or destruction
- •Patient must be felt to have failed, be unable to significantly benefit from, or be at risk for other available therapies, including surgeries, embolization, and sclerotherapy based on unanimous assessment of designated physicians in the multidisciplinary Vascular Anomalies Team.
- •Patient must be felt to have one or more physical, imaging, photographic, physiologic or other measurable features that can be measured on a regular basis for preliminary evaluation of efficacy. The feature(s) must be agreed on by the designated physicians in the multidisciplinary Vascular Anomalies Team).
- •Signed Patient informed consent.
排除标准
- •Pregnancy
- •Patient nursing child.
- •Female patient of childbearing potential unwilling to receive contraceptive counseling and use reliable contraceptive method.
- •Patient enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- •Parent or guardian or child unwilling to provide consent or assent.
结局指标
主要结局
History
Physical Examination
Laboratory studies
Vital Signs
EKG
Urine studies
次要结局
- Individualized. Change in the predetermined measure of the vascular anomaly.
研究者
研究点 (2)
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