A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 in Subjects With Lymphoid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This study is to determine the appropriate dosing regimen of GS-9820 in subjects with lymphoid malignancies. This is a Phase 1b, open-label, dose-escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of GS-9820.
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
- •Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL
- •Measurable lymphadenopathy
- •Requires therapy
排除标准
- •Recent history of a major non-lymphoid malignancy
- •Evidence of ongoing infection
- •Concurrent participation in another therapeutic clinical trial
研究组 & 干预措施
GS-9820
Participants will be sequentially enrolled at progressively higher dose levels to receive GS-9820 administered twice a day. Escalation will proceed to the maximum tolerated dose (MTD), defined as the highest tested dose associated with a rate of dose-limiting toxicities (DLT) of < 33% during the first 4 weeks of therapy.
干预措施: GS-9820 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Up to 4 weeks
MTD will be assessed to determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies.
次要结局
- Overall safety(Up to 5 years)
- Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC(Baseline to Day 29)
- Pharmacodynamics to measure changes in the phosphatidylinositol 3-kinase (P13K) delta pathway activation and changes in plasma concentration of disease-associated chemokines and cytokines(Baseline to Day 29)
- Tumor control(Up to 5 years)
- Patient well-being assessed using changes in baseline in HRQL (health related quality of life questionnaire) domain and symptom scores based on the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym)(Up to 5 years)
- Drug exposure(Up to 5 years)