Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)
研究概览
简要总结
Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
详细描述
This is an open label, non-randomized, single-arm continuation protocol study using ZEN003694. Patients who have completed participation in their original ("parent") ZEN003694 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in the continuation protocol. The patient must have been enrolled in a Zenith Epigenetics sponsored ZEN003694 therapeutic study to be eligible for participation in this continuation protocol.
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
- •Protocol-defined completion in a parent ZEN003694 trial
- •Patient has clinical benefit as determined by the investigator at the time of entry to the continuation protocol
- •ECOG performance status of 0 or 1
- •Acceptable ZEN003694 tolerability, in the judgment of the investigator
- •Initiation of dosing in this continuation trial to occur within two weeks (14 days) of completing dosing in the parent trial, unless more time is approved by the sponsor in writing
排除标准
- •Concurrent participation in another clinical investigational treatment trial
- •Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study
- •Discontinued ZEN003694 or withdrew consent to participate in original Zenith Epigenetics-sponsored ZEN003694 study
- •Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule
研究组 & 干预措施
Experimental: ZEN003694 in Combination with Enzalutamide
Patients who have completed participation in their original ZEN003694-002 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in combination with enzalutamide
干预措施: ZEN003694 (Drug)
Experimental: ZEN003694 in Combination with Enzalutamide
Patients who have completed participation in their original ZEN003694-002 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in combination with enzalutamide
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)
时间窗: Up to 3 years
次要结局
- Evaluate Overall survival (OS): Time from date of first dose of ZEN003694 in the parent protocol or randomization to the date of death from any cause(Up to 3 years)
- Evaluate radiographic response rate by RECIST 1.1 criteria(Up to 3 years)