A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 665
- 试验地点
- 1
- 主要终点
- Overall Survival Time (OS)
研究概览
简要总结
This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.
详细描述
The aim of this study is to determine if paclitaxel given together with ramucirumab (IMC-1211B) as second line therapy will prolong overall survival (OS) compared to paclitaxel alone.
Approximately 663 participants (at least 18 years) in approximately 200 study centers and in approximately 30 countries will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma. Participants must have received at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy prior to study entry due to disease progression.
Upon registration and completion of screening procedure and reviewing the Inclusion and Exclusion Criteria eligible participants will be randomized to receive either paclitaxel plus ramucirumab or paclitaxel plus placebo.
Ramucirumab (IMC-1211B) DP/placebo will be administered IV on Days 1 and 15, paclitaxel will be administered IV on Days 1, 8 and 15 of a 4 weekly cycle.
Participants will be continuously treated and monitored until radiographic or symptomatic progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
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
- •Signed informed consent
- •histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
- •Metastatic disease or locally advanced, unresectable disease
- •Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline)
- •Organs are functioning well (liver, kidney, blood)
- •Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1
排除标准
- •First line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline
- •Previous systemic therapy with other anti-angiogenic drugs
- •Uncontrolled high blood pressure
- •Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month
- •Evidence of central nervous system (CNS) metastasis at baseline
研究组 & 干预措施
Ramucirumab (IMC-1211B) Drug Product (DP) and Paclitaxel
Ramucirumab (IMC-1211B) DP and Paclitaxel
干预措施: Ramucirumab (IMC-1211B) DP (Biological)
Ramucirumab (IMC-1211B) Drug Product (DP) and Paclitaxel
Ramucirumab (IMC-1211B) DP and Paclitaxel
干预措施: Paclitaxel (Drug)
Placebo and Paclitaxel
Placebo and Paclitaxel
干预措施: Placebo (Drug)
Placebo and Paclitaxel
Placebo and Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall Survival Time (OS)
时间窗: Randomization up to 27.5 months
OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.
次要结局
- Time to Progressive Disease (TTP)(Baseline up to 22.2 months)
- Cmax After 4th Ramucirumab (IMC-1211B) Infusion(Cycle 2, Day 15 1 hour post end of infusion (28-day cycles))
- Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion(Cycle 2, Day 15 (28-day cycle))
- Percentage of Participants With CR or PR (Objective Response Rate [ORR])(Randomization up to 22.2 months)
- Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion(Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles))
- Cmax After 7th Ramucirumab (IMC-1211B) Infusion(Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles))
- Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion(Cycle 1, Day 1 predose (28-day cycles))
- Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion(Cycle 4, Day 1 (28-day cycles))
- Progression-Free Survival (PFS)(Randomization up to 22.2 months)
- Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD(Randomization up to 22.2 months)
- Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)(Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks)
- Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status(Baseline, end of therapy (up to 103 weeks))
- Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score(Baseline, end of therapy (up to 103 weeks))