A Phase 2 Study of Oral Enzastaurin HCl in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Progression Free Survival (PFS) at 6 Months
研究概览
简要总结
Enzastaurin given daily to participants with colorectal cancer who have Stage 4 disease and have not received prior chemotherapy for advanced colorectal cancer
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with colorectal cancer that is advanced or metastatic (has spread to other parts of the body); able to visit the doctor's office every 28 days for at least 6 months; able to swallow tablets
排除标准
- •women cannot be pregnant or breastfeeding; no history of significant heart disease or any other significant medical problems as determined by the participant's physician
研究组 & 干预措施
Enzastaurin HCl
干预措施: Enzastaurin HCl (Drug)
结局指标
主要结局
Percentage of Participants With Progression Free Survival (PFS) at 6 Months
时间窗: Baseline to 6 months
PFS defined as time from date of first dose of enzastaurin to first date of documented progressive disease (PD) or date of death (any cause), whichever occurred first. Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) PD defined as ≥20% increase in sum of the longest diameter (LD) of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of ≥1 new lesions. Participants not known to have died as of data-inclusion cut-off date and who did not have PD, PFS was censored at date of last progression-free disease assessment prior to date of any post discontinuation anticancer therapy. Participants who took any subsequent systemic anticancer therapy prior to PD or death, PFS was censored at date of last progression-free disease assessment prior to the date of any post discontinuation anticancer therapy. PFS at 6 months = participants who were progression free and alive at 6 months divided by the number of treated participants x 100.
次要结局
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)](Baseline to measured progressive disease (PD) up to 24 months)
- Change From Baseline in QTc Interval(Baseline, Cycle 1 Day 1 and Cycle 2 Day 1 of 28-day cycles)
- Progression Free Survival (PFS)(Baseline to measured PD up to 9 months)
- Number of Participants With Adverse Events (AEs) or Who Died(Baseline to study completion up to 24 months and 30-day post-study discontinuation)
- Duration of Stable Disease (SD)(Time from SD to measured PD up to 9 months)
- Pharmacokinetics-Minimum Observed Concentration (Cmin) of Total Analytes(Cycle 1 Day 2-predose, Cycle 2 Day 1-predose and Cycle 3 Day 1-predose of 28-day cycles)
- Overall Survival (OS)(Baseline to date of death from any cause up to 24 months)
- Time to Treatment Response(Baseline to date of confirmed response up to 24 months)
- Change From Baseline in Carcinoembryonic Antigen (CEA) Response at Each Cycle(Baseline and Cycles 1, 2, 3, 4, 5, 6 (28-day cycles))
- Duration of Complete Response (CR) or Partial Response (PR) (Duration of Response)(Time from response to PD)