Protocol EC-FV-05: An Open-label, Multi-center, Extension Study of EC145 Administered Weeks 1 and 3 of a 4-Week Cycle in Subjects Enrolled in a Previous Study With EC145
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of participants experiencing adverse events
研究概览
简要总结
This extension protocol is for those subjects that have completed the allowed duration of participation in an Endocyte-sponsored clinical trial of EC145 (vintafolide) and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study.
详细描述
This extension protocol is for those subjects that have completed the allowed duration of participation in an Endocyte-sponsored clinical trial of EC145 and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study.
Following confirmation of eligibility, subjects will receive intravenously-administered EC145 at a dose of 2.5 mg. Dosing will occur on Monday, Wednesday, and Friday of weeks 1 and 3 of each 4-week cycle. No therapy will be administered during weeks 2 and 4. Subjects randomized to non-EC145-containing treatment arms of EC145 trials are not eligible for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Must have received prior treatment with EC145 within the context of an Endocyte-sponsored, IRB-approved clinical trial.
- •Disease (i.e., cancer) that was considered "stable" at the last evaluation while participating in the previous EC145-containing study. "Stable" is defined as not having progression of disease per standard criteria (RECIST, etc). Stable disease may be indicated by previously attained complete or partial tumor shrinkage that has not progressed per standard criteria.
- •No more than 10 weeks have elapsed since the last evaluation of "stable disease".
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Must have recovered (to baseline/stabilization) from prior EC145-associated acute toxicities.
- •Adequate bone marrow reserve, hepatic, and renal function.
- •Negative serum pregnancy test for women of childbearing potential
- •Willingness to practice contraceptive methods for men and women of childbearing potential.
排除标准
- •Pregnancy.
- •Development of a secondary malignancy requiring treatment.
- •Symptomatic central nervous system (CNS) metastasis.
- •History of receiving any investigational treatment or other systemic therapy directed at controlling cancer since the subject's last dose on the parent EC145 study.
研究组 & 干预措施
All Participants
All participants invited to enroll on study will receive EC145 (vintafolide) 2.5 mg by intravenous bolus on Monday, Wednesday, and Friday of Weeks 1 and 3 in each 4-week cycle.
干预措施: EC145 (Drug)
结局指标
主要结局
Number of participants experiencing adverse events
时间窗: Up to 2 years
Number of participants experiencing serious adverse events
时间窗: Up to 2 years
Number of participants discontinuing study drug due to adverse events
时间窗: Up to 2 years
次要结局
未报告次要终点