A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Disease Control Rate
研究概览
简要总结
Marqibo (liposomal vincristine) is a form of vincristine preparation. Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growing and spreading throughout the body. This may cause the cancer cells to die. Liposomal vincristine is formed when vincristine is placed inside of oil droplets called liposomes, which may help to improve the delivery of drug to the tumor site. The liposomal formulation results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer cells to vincristine continuously.
The goal of this clinical research study is to learn if Marqibo (liposomal vincristine) can help to control metastatic uveal melanoma. The safety of liposomal vincristine will also be studied.
Approximately 50 patients will take part in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Uveal melanoma with histologic or cytologic confirmation of metastatic disease.
- •One unidimensionally measurable lesion. If this is a cutaneous lesion it must be at least 10 mm by caliper measure. If it is a visceral or nodal or soft tissue lesion, it must be >20 mm with conventional techniques or >10 mm with spiral CT scan. Bone lesions are not considered measurable.
- •Must not have received any prior systemic chemotherapy, immunotherapy, vaccine or hepatic arterial chemotherapy for metastatic disease.
- •Adequate liver, renal, and bone marrow function.
- •Zubrod performance status of 0-
- •Sign an informed consent form.
排除标准
- •Major surgery within 4 weeks of enrollment.
- •Advanced symptomatic central nervous system (CNS) involvement by melanoma and those on phenytoin or requiring steroids for brain metastases, spinal cord compression, or meningeal "carcinomatosis".
- •History of neurological disorders unrelated to chemotherapy (including familial neurological diseases and acquired demyelinating disorders).
- •Grade 2 or greater sensory, motor and/or autonomic neuropathy at screening from any cause.
- •Receiving treatment with drugs known to inhibit or induce hepatic drug metabolism by cytochrome P450-3A4 isoenzymes and/or P-glycoprotein within 1 week of study enrollment.
研究组 & 干预措施
Cohort 1
Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
干预措施: Marqibo® (vincristine sulfate liposomes injection) (Drug)
Cohort 2
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
干预措施: Marqibo® (vincristine sulfate liposomes injection) (Drug)
结局指标
主要结局
Disease Control Rate
时间窗: 1 year
Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD)
次要结局
未报告次要终点