A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Enzastaurin With 5-FU/LV Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic Colorectal Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologic diagnosis of locally advanced or metastatic colorectal cancer (CRC) that is not curable. The histology types to be included are adenocarcinoma, mucinous adenocarcinoma, signet ring, and undifferentiated. Patients with neuroendocrine carcinomas will be excluded.
- •Received 6 cycles (3 months [12 weeks]) of first-line therapy with FOLFOX or FOLFIRI, plus bevacizumab for metastatic CRC. Patients have received at least 5 cycles with bevacizumab. Patients who received 6 cycles of first-line therapy with FOLFOX or FOLFIRI, plus bevacizumab for recurrent CRC that has relapsed at least 12 months after completion of adjuvant therapy will also be included. All standard FOLFOX (FOLFIRI) regimens given on a biweekly schedule will be permitted; however, 21-day regimens will not be allowed.
- •No more than 4 weeks may pass between the end of first-line therapy (that is, Day 14 of Cycle 6) and randomization.
- •Documented evidence of tumor response of complete response (CR), partial response (PR), or stable disease (SD) by computed tomography (CT) scan or magnetic resonance imaging (MRI). Confirmation of response is not required.
排除标准
- •Are unable to swallow tablets.
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Have known central nervous system metastases.
- •Are receiving concurrent administration of any other antitumor therapy.
- •Patients who have significant heart, liver, kidney, or psychiatric disease or have an active infection
研究组 & 干预措施
Enzastaurin + 5-FU/LV + Bev
5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with enzastaurin
干预措施: Enzastaurin (Drug)
Enzastaurin + 5-FU/LV + Bev
5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with enzastaurin
干预措施: Leucovorin (LV) (Drug)
Enzastaurin + 5-FU/LV + Bev
5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with enzastaurin
干预措施: 5-fluorouracil (5-FU) (Drug)
Enzastaurin + 5-FU/LV + Bev
5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with enzastaurin
干预措施: Bevacizumab (Bev) (Drug)
Placebo + 5-FU/LV + Bev
5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with placebo
干预措施: Placebo (Drug)
Placebo + 5-FU/LV + Bev
5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with placebo
干预措施: Leucovorin (LV) (Drug)
Placebo + 5-FU/LV + Bev
5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with placebo
干预措施: 5-fluorouracil (5-FU) (Drug)
Placebo + 5-FU/LV + Bev
5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with placebo
干预措施: Bevacizumab (Bev) (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Randomization to measured progressive disease or death up to 17.2 months
PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. Progressive disease was determined using a modified version of Response Evaluation Criteria in Solid Tumor (RECIST) Assessment and was defined as at least a 20% increase in sum of longest diameter of target lesions. Time to disease progression was censored at the date of death if death was due to other cause.
次要结局
- Overall Survival (OS) From Start of First Line Therapy(Start of first line therapy (approximately 3 months prior to randomization) to date of death from any cause up to 27 months post randomization)
- Number of Participants With Adverse Events (AEs)(Randomization up to 17.2 months)
- Overall Survival (OS)(Randomization up to 22.8 months)
- PFS From Start of First Line Therapy(Start of first line therapy to measured progressive disease or death up to 24 months)