NCT00219557已完成2 期
A RANDOMIZED PHASE 2 STUDY OF THE ANTI-ANGIOGENESIS AGENT AG-013736 IN COMBINATION WITH GEMCITABINE IN PATIENTS WITH CHEMOTHERAPY-NAIVE ADVANCED PANCREATIC CANCER PRECEDED BY A PHASE 1 PORTION
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 111
- 试验地点
- 35
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.
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
- •patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas
- •no prior therapy for metastatic disease
排除标准
- •patients with locally advanced disease who are candidates for radiation therapy.
- •uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)
研究组 & 干预措施
Gemcitabine
Active Comparator
干预措施: Gemcitabine (Drug)
Axitinib [AG-013736] plus gemcitabine
Experimental
干预措施: AG-013736 (Drug)
Axitinib [AG-013736] plus gemcitabine
Experimental
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant
Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
次要结局
- Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)(0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1)
- Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)(Phase 1 baseline up to Week 4)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine(0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1)
- Percentage of Participants With Overall Response (OR)(Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)(0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1)
- Maximum Observed Plasma Concentration (Cmax) of Gemcitabine(0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1)
- Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study(Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).)
- Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)(Phase 1 Baseline up to Week 4)
- Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)(0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1)
- Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)(0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1)
- Plasma Decay Half-life (t1/2) of Gemcitabine(0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1)
- Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2(Phase 2 Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 80 weeks)
- Duration of Response (DR)(Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks)
- Progression-free Survival (PFS)(Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks)
- One Year Survival Probability(Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant)
- Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study(Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).)
研究者
研究点 (35)
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