A Phase 2 Study of Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Freedom From Progression (FFP) for at Least 3 Cycles
研究概览
简要总结
The purposes of this study are to determine the safety of oral enzastaurin and any side effects that might be associated with it and whether enzastaurin can help participants with mantle cell 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
- •Mantle cell lymphoma
- •Previous treatment for mantle cell lymphoma
- •Previously relapsed mantle cell lymphoma with no more than 4 chemotherapy regimens.
- •Have discontinued all previous therapies for cancer, except corticosteroids up to 25 milligrams per day (mg/day)
- •Adequate organ function
排除标准
- •Inability to swallow tablets
- •Must not have significant heart problems
研究组 & 干预措施
A
干预措施: enzastaurin (Drug)
结局指标
主要结局
Percentage of Participants With Freedom From Progression (FFP) for at Least 3 Cycles
时间窗: Baseline through at least 3 cycles of treatment (28-day cycle)
Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. The percentage of FFP was computed as the number of participants documented to be progression free after 3 cycles of treatment divided by the number of treated participants and then multiplied by 100.
次要结局
- Duration of CR, CRu, PR or Stable Disease (SD) [Duration of Overall Response](Date of progression or death due to any cause up to 22.01 months)
- Time to New Treatment(Baseline to date of new treatment up to 23.10 months)
- Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status)(Baseline, Cycles 2, 4 and 6)
- Progression-Free Survival (PFS)(Baseline to measured progressive disease or death due to any cause up to 22.01 months)
- Overall Survival (OS)(Baseline to date of death from any cause at least up to 23.10 months)
- Average Steady-State Plasma Concentration (Cav,ss,) of Enzastaurin and Total Analytes (Pharmacokinetics of Enzastaurin and Total Analytes)(Cycles 1 [1-4 hours (h) and 4-8 h postdose], 2 (predose, 2-4 h and 6-8 h postdose), and 3 (predose and 2-8 h postdose) of Day 1 of each 28-day cycle)
- Number of Participants With High Ki-67 Expression by IHC Staining(Baseline)
- Percentage of Participants With Complete Response (CR) Plus Unconfirmed Complete Response (CRu) Plus Partial Response (PR) (Objective Response Rate)(Baseline to 22.01 months)
- Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)(Baseline, Cycles 2, 4 and 6 (28-day cycle))
- Number of Participants With Protein Kinase C Beta (PKCβ) Expression by Immunohistochemistry (IHC) Staining(Baseline)
- Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin)(Each cycle (28-day cycle) up to 21 cycles and 30-day follow-up)