Extended Use of CS 7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Subjects With Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 主要终点
- Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
研究概览
简要总结
This is a study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug. Participants who have not progressed while receiving CS-7017 will continue to benefit from longer administration of the agent.
详细描述
This is an open-label non-randomized study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant previously treated with CS-7017 as part of a study that included CS-7017 and has shown clinical benefits from treatment with CS-7017.
排除标准
- •Anticipation of need for a major surgical procedure or radiation therapy during the study.
- •Any of the following conditions within 6 months prior to initiating study treatment: Myocardial infarction with significant impairment of cardiac function (eg, ejection fraction ≤ 50%), severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class II or higher congestive heart failure.
- •Participants with clinically significant pleural or pericardial effusions.
- •Clinically significant active infection, which requires antibiotic therapy, or human immune deficiency virus (HIV)-positive subjects receiving antiretroviral therapy.
- •Participants with diabetes mellitus requiring treatment with insulin, sulfonylureas or thiazolidinediones (TZDs) agents, malabsorption syndrome, chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction.
研究组 & 干预措施
1
CS-7017 tablets twice daily at strength ranging from 0.5 mg to 0.75 mg
干预措施: CS-7017 (Drug)
结局指标
主要结局
Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
时间窗: From baseline and every 6 weeks postdose, up to 2 years 6 months
At each evaluation, the participant's status was assessed as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD); the best response was then identified. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions).
次要结局
- Response/Stable Disease Duration and Time to Progression Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer(Baseline and every 6 weeks postdose, up to 2 years 6 months)
- Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer(Baseline up to 30 days after last dose, up to 2 years 6 months)