A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC).
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
- Double (Participant, Investigator)
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
- •Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease which cannot be cured.
- •Participants must have disease which progressed after 1 prior systemic cytotoxic chemotherapy regimen for advanced disease.
- •At least 1 measurable lesion.
- •Must have stopped all previous systemic therapies for cancer for at least 2 weeks prior to enrollment.
- •Must be able to follow study guidelines and be able to show up for appointments.
排除标准
- •Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Previous treatment with enzastaurin or pemetrexed.
- •Concurrent administration of any other antitumor therapy.
- •Inability to swallow tablets.
- •Pregnant or breastfeeding.
研究组 & 干预措施
Pemetrexed + Enzastaurin
干预措施: enzastaurin (Drug)
Pemetrexed + Enzastaurin
干预措施: pemetrexed (Drug)
Pemetrexed + Placebo
干预措施: placebo (Drug)
Pemetrexed + Placebo
干预措施: pemetrexed (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Baseline to measured progressive disease up to 9.92 months
PFS was defined as the time from date of randomization to the first documented observation of disease progression or death from any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death at the data inclusion cut-off date.
次要结局
- Overall Survival (OS)(Baseline to date of death from any cause up to 12.32 months)
- Tumor Biomarkers(Tumor samples collected at baseline)
- Duration of Disease Control (DDC)(Baseline to measured progressive disease up to 9.92 months)
- Percentage of Participants With Complete Response or Partial Response (Tumor Response Rate)(Baseline to measured progressive disease up to 9.92 months)
- Time-to-Worsening (TW) in Lung Cancer Symptom Scale (LCSS) - Health Related Quality of Life (HRQoL) Subscale(Baseline to disease worsening up to 10.58 months)