A Phase 2 Evaluation of Oral LY317615 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Relapsed or Refractory DLBCL Who Are Progression-Free for at Least 2 Cycles (28-Day Cycles) After Receiving Enzastaurin (LY317615) (Clinical Response Rate)
研究概览
简要总结
This study will measure the effectiveness and any side effects of LY317615 in participants with diffuse large B-cell lymphoma (DLBCL: a sub-type of Non-Hodgkins Lymphoma).
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
- •A diagnosis of recurrent or refractory DLBCL.
- •Adequate organ functions.
- •Able to swallow capsules.
排除标准
- •More than 3 prior treatments for this disease.
- •Serious heart problems.
研究组 & 干预措施
LY317615
500 milligrams (mg), oral, daily (QD), up to six (6) 28-day cycles
干预措施: LY317615 (Drug)
结局指标
主要结局
Percentage of Participants With Relapsed or Refractory DLBCL Who Are Progression-Free for at Least 2 Cycles (28-Day Cycles) After Receiving Enzastaurin (LY317615) (Clinical Response Rate)
时间窗: Randomization to measured progressive disease (PD) up to 34.3 months
Clinical Response Rate in participants with DLBCL was calculated as (number of participants who were progression-free for at least two 28-day cycles \[clinical responder\]) divided by (total number of participants analyzed) multiplied by 100. Progression free survival (PFS) defined as the time from randomization to the first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate)(Randomization to measured PD or death up to 34.3 months)
- Progression Free Survival (PFS)(Randomization to PD or death due to any cause up to 34.3 months)
- Duration of Overall Response (DOR)(Time of response to PD up to 34.3 months)
- Number of Participants With Adverse Events (AEs) or Who Died(Randomization to study completion [Baseline up to 37 cycles (28-day cycles, 34.3 months) and 30-day follow-up])
- Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval (AUC0-24,ss) of Enzastaurin and Its Metabolite LY326020(Cycle 1 Day 1 predose, 1 to 4 hours postdose and Cycle 1 Day 28 predose and at least 1-hour postdose (28-day cycle))
- PKCβ Expression by IHC in Readily Assessable DLBCL Tumors From Participants(Baseline)