A Phase 2, Open-label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Non-small Cell Lung Cancer Refractory to Platinum-based Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 13
研究概览
简要总结
This non-randomized, open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321. Patients must have been previously treated with a platinum-containing chemotherapy regimen.
A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside of this research trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Recurrence of non-small cell lung cancer after at least 1 prior chemotherapy regimen containing a platinum agent
- •Recovery from all acute side effects of prior therapies (with the exception of hair loss)
- •Adequate bone marrow, liver, and kidney function
排除标准
- •More than 2 prior chemotherapy regimens for treatment of advanced or metastatic non-small cell lung cancer. (Treatment given in conjunction with surgery will not be included in the maximum of 2 prior regimens)
- •Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of beginning study
- •Symptomatic brain metastases
