A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and duration of tumor control
详细描述
This is a Phase 2, multicenter, single-arm, controlled, clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor GS-1101 (CAL-101) as therapy for previously treated chronic lymphocytic leukemia.
This clinical trial (Study GS-US-312-0120) is a single-arm in which compliant subjects from GS US-312-0119 -Arm B who experience progression of CLL while receiving single-agent ofatumumab therapy are potentially eligible to receive single-agent, open-label GS 1101 therapy.
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
- •Participation in Study GS-US-312-0119
- •Occurrence of confirmed progression of CLL while receiving single-agent ofatumumab in Study GS US 312
- •Permanent cessation of Study GS-US-312-0119 (single-agent ofatumumab) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of CLL.
- •The time from permanent cessation of single-agent ofatumumab on Study GS-US-312-0119 and the initiation of GS 1101 on Study GS-US-312-0120 is no more than 12 weeks.
排除标准
- 未提供
研究组 & 干预措施
GS-1101
GS-1101 (oral; 150 mg BID)
干预措施: GS-1101 (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 18 mon
Patient Well-Being
时间窗: 18 months
Health-related quality-of-life questionnaire
Disease-related Biomarkers
时间窗: 18 months
Pharmacokinetics
时间窗: 6 months
Evaluation of plasma concentrations at peak (Cmax) and trough (Cmin)
Incidence of Adverse Events
时间窗: 18 months
Health Resource Utilization
时间窗: 18 months
次要结局
未报告次要终点