NCT00486954已完成3 期
A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone in the Second Line Treatment of ErbB2 Amplified Advanced Gastric 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
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study
研究概览
简要总结
EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Paclitaxel plus Lapatinib
Experimental
6 pills of lapatinib at 250 mg each once daily and infusion of paclitaxel at 80 mglm2 weekly
干预措施: Lapatinib (Drug)
Paclitaxel plus Lapatinib
Experimental
6 pills of lapatinib at 250 mg each once daily and infusion of paclitaxel at 80 mglm2 weekly
干预措施: Paclitaxel (Drug)
Paclitaxel alone
Active Comparator
Infusion of paclitaxel at 80 mglm2 weekly
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study
时间窗: 28 days
DLTs consisted of only drug-related toxicities (neurologic and non-neurologic DLTs). A neurologic DLT was defined as grade 3/4 clinically significant peripheral motor and/or sensitive neuropathy. Non-neurologic DLTs mainly included the following: grade 3/4 clinically significant non-hematological toxicity (except nausea), grade 4 neutropenia lasting \>=7 days, thrombocytopenia (\<=25000 cells per cubic millimeter), inability to begin next treatment within 2 weeks of scheduled dosing due to unresolved toxicity, treatment delay (due to toxicity) of \>5 days, for Days 8 or 15 of weekly paclitaxel.
Overall Survival (OS) in the Randomized Part of the Study
时间窗: From randomization until death due to any cause (up to 42.58 months)
OS was defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. For censored participants, time to death was defined as the time from randomization to the time of last contact.
次要结局
- Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study(Days 8 and 14)
- Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study(Days 8 and 14)
- Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study(Days 8 and 14)
- Cmax of Paclitaxel in the Pilot Part of the Study(Days 1 and 8)
- Tmax of Paclitaxel in the Pilot Part of the Study(Days 1 and 8)
- AUC(0-24) of Paclitaxel in the Pilot Part of the Study(Days 1 and 8)
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study(Days 1 and 8)
- Half-life of Paclitaxel in the Pilot Part of the Study(Days 1 and 8)
- Clearance of Paclitaxel in the Pilot Part of the Study(Days 1 and 8)
- Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study(Days 1 and 8)
- Progression-free Survival (PFS) in the Randomized Part of the Study(From randomization until disease progression or death due to any cause (up to 42.35 months))
- Time to Progression in the Randomized Part of the Study(From randomization until disease progression or death due to disease (up to 42.35 months ))
- Percentage of Participants With Overall Response in the Randomized Part of the Study(From randomization up to 5.62 months)
- Number of Participants With the Indicated Time to Response in the Randomized Part of the Study(up to 5.62 months)
- Duration of Response in the Randomized Part of the Study(up to 18.27 months)
- Number of Participants With the Indicated Grade 3 and Grade 4 Adverse Events (AEs) for Which All Grades of the AE Were Reported in >=10% of Participants, Regardless of Causality in the Randomized Part of the Study(From the first dose of investigational product to 30 days after the last dose (up to 110.3 weeks in the Randomized part))
- Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QOL Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Physical Functioning Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Role Functioning Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Social Functioning Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Fatigue Symptom Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Symptom Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Pain Symptom Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Dyspnea Symptom Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Insomnia Symptom Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Appetite Loss Symptom Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Constipation Symptom Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Diarrhea Symptom Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Symptom Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-STO22 Dysphagia Scale Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-STO22 Pain Scale Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-STO22 Reflux Symptoms Scale Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-STO22 Eating Restrictions Scale Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-STO22 Anxiety Scale Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-STO22 Dry Mouth Scale Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-STO22 Taste Scale Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-STO22 Body Image Scale Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Change From Baseline in the EORTC QLQ-STO22 Hair Loss Scale Score at the End of Therapy in the Randomized Part of the Study(Baseline and end of therapy (up to 42.58 months))
- Number of Participants With the Indicated Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry Intensity in the Randomized Part of the Study(Pretreatment)
- Number of Participants With the Indicated Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry Intensity in the Randomized Part of the Study(Pretreatment)
- Number of Participants With Mutations That May Correlate With Response and Toxicity to Lapatinib(Pretreatment)
研究者
研究点 (1)
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