NCT00267020已完成2 期
A Randomized, Open-Label Phase 2 Study of 2 Regimens, Gemcitabine Plus Enzastaurin and Single-Agent Gemcitabine, in Patients With Locally Advanced or Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in participants with pancreatic 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
- 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
- •Diagnosis of adenocarcinoma of the pancreas.
- •Pretreatment tumor specimen must be available.
- •No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for pancreatic cancer, including 5-fluorouracil (5-FU) with radiation therapy.
- •Prior radiation allowed.
- •Ability to stop some types of anti-seizure medicines within 14 days of enrollment.
排除标准
- •Endocrine pancreatic tumor or ampullary cancer.
- •Central Nervous System (CNS) metastases.
- •Inability to swallow tablets.
- •10% or greater weight loss over the 6 weeks before study entry.
研究组 & 干预措施
Enzastaurin+Gemcitabine
Experimental
干预措施: enzastaurin (Drug)
Enzastaurin+Gemcitabine
Experimental
干预措施: gemcitabine (Drug)
Gemcitabine
Active Comparator
干预措施: gemcitabine (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Randomization to the date of death from any cause up to 27.7 months
OS was the duration from randomization to death. OS was censored at the last contact for participants who were alive, at the cut-off date.
次要结局
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)(Randomization to measured progressive disease (PD) up to 19.9 months)
- Change in Scores From Baseline (Improved, Stable or Worsened) to End of Study in Functional Assessment of Cancer Therapy Hepatobiliary Version 4 ( FACT-Hep v.4) (Quality of Life (QOL))(Baseline through end of study up to 27.7 months)
- Carbohydrate Antigen 19-9 (CA 19-9) Concentration in the Blood(Cycles 1 to 6, and post-treatment (up to 27.7 months))
- Progression Free Survival (PFS)(Randomization to measured PD or death from any cause up to 21.6 months)
- Duration of Response(Time of response to PD or death from any cause up to 19.9 months)
- Relationship of Steady-State Drug Levels to Clinical Outcomes of Overall Survival (OS)(Randomization to date of death from any cause up to 27.7 months)
- Relationship of Steady-state Drug Levels to Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Disease Control)(Beginning of treatment up to 27.7 months)
- Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) (Toxicity)(Baseline through study completion (Up To 27.7 Months))
研究者
研究点 (1)
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