A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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
- •adult patients, >=18 years of age;
- •histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
- •measurable disease according to RECIST;
- •failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
- •ECOG performance status of 0-2.
排除标准
- •local or locally advanced-resectable pancreatic cancer;
- •any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
- •major surgery within 2 weeks prior to randomization.
研究组 & 干预措施
Erlotinib
Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
干预措施: Erlotinib (Drug)
Placebo
Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: From the time of randomization until progression of disease or death (up to 30 months)
Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method.
次要结局
- Overall Survival(From the time of randomization until or death (up to 30 months))
- Percentage of Participants With Best Overall Response Rate(From the time of randomization until progression of disease or death (up to 30 months))
- Percentage of Participants With Disease Control Rate (DCR)(Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months))
- Number of Participants With Adverse Events (AEs)(Up to 28 days after discontinuation of study drug (up to 30 months))