A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Percent of Participants With a Serious Drug-related Adverse Event (AE)
研究概览
简要总结
This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.
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
- •Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug
- •Patient did not withdraw from the base protocol
- •Patient agrees to practice effective birth control during the study
排除标准
- •Patient is receiving other standard and/or investigational anticancer therapy
- •Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug
研究组 & 干预措施
Vorinostat
干预措施: vorinostat (Drug)
结局指标
主要结局
Percent of Participants With a Serious Drug-related Adverse Event (AE)
时间窗: From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)
A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose. A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug.
次要结局
未报告次要终点