NCT00471146已完成3 期
A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.
详细描述
This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.
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
- •Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
- •Adequate renal, hepatic and bone marrow function.
- •Performance status 0 or 1.
排除标准
- •Prior treatment with any systemic chemotherapy for metastatic disease.
- •Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
- •Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
- •Inability to take oral medication.
研究组 & 干预措施
A
Experimental
干预措施: AG-013736 (Drug)
A
Experimental
干预措施: Gemcitabine (Drug)
B
Active Comparator
干预措施: Gemcitabine (Drug)
B
Active Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline until death or at least 1 year after the randomization of last participant
Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. 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
- Percentage of Participants With Objective Response (OR)(Baseline, every 8 weeks until tumor progression or death)
- Progression Free Survival (PFS)(Baseline until disease progression or at least 1 year after the randomization of last participant)
- Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score(Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal)
- Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score(Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal)
- Duration of Response (DR)(Baseline until death or at least 1 year after the randomization of last participant)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score(Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal)
- Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile(Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal)
- Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)(Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months)
- Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score(Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal)
研究者
研究点 (1)
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