NCT01001377已完成3 期
A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal 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
- Amgen
- 入组人数
- 1,010
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.
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
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, metastatic disease
- •Wild-type KRAS tumor status
- •Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2
- •Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease
- •Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC)
- •Adequate hematologic, renal, hepatic and metabolic function
排除标准
- •Symptomatic brain metastases requiring treatment
- •Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
- •Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before randomization.
- •Clinically significant cardiovascular disease
- •Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to randomization
研究组 & 干预措施
Cetuximab
Active Comparator
Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
干预措施: Cetuximab (Drug)
Panitumumab
Experimental
Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
干预措施: Panitumumab (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.
次要结局
- Time to Treatment Failure(From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.)
- Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score(From Study Day 1 through the last day of treatment or disease progression, up to Week 85.)
- Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)(From Study Day 1 through the last day of treatment or disease progression, up to Week 85.)
- Progression-free Survival(From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.)
- Objective Response(From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.)
- Duration of Response(From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.)
- Time to Response(From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.)
- Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score(From Study Day 1 through the last day of treatment or disease progression, up to Week 85.)
- Change From Baseline in NCCN FCSI Physical Well-being Scale Score(From Study Day 1 through the last day of treatment or disease progression, up to Week 85.)
- Change From Baseline in NCCN FCSI Functional Well-being Scale Score(From Study Day 1 through the last day of treatment or disease progression, up to Week 85.)
- Number of Participants With Adverse Events (AEs)(From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.)
研究者
研究点 (1)
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