A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus AMG 102
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 130
- 主要终点
- Progression free survival (PFS), as measured by RECIST per local review
研究概览
简要总结
Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma.
Primary Objective(s):
Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX.
Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).
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
- •Pathologically confirmed unresectable locally advanced or metastatic gastric or esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus within 5 cm of the EGJ are eligible
- •ECOG performance status 0 or 1
- •Male or female ≥ 18 years of age
排除标准
- •Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or metastatic gastric or esophagogastric adenocarcinoma
- •Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy.
- •Subjects with resectable disease or suitable for definitive chemoradiation
- •Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy
- •Tumors of squamous cell histology
- •Known central nervous system metastases
- •Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization
- •Serious or non-healing wound
研究组 & 干预措施
Phase 2 Arm C
AMG 102 placebo plus ECX
干预措施: Capecitabine (Drug)
Phase 2 Arm C
AMG 102 placebo plus ECX
干预措施: Epirubicin (Drug)
Phase 2 Arm C
AMG 102 placebo plus ECX
干预措施: Cisplatin (Drug)
Phase 2 Arm C
AMG 102 placebo plus ECX
干预措施: Placebo (Drug)
Phase 1b
Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.
干预措施: Capecitabine (Drug)
Phase 1b
Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.
干预措施: Epirubicin (Drug)
Phase 1b
Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.
干预措施: AMG 102 (Drug)
Phase 1b
Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed.
干预措施: Cisplatin (Drug)
Phase 2 Arm B
AMG 102 at 7.5mg/kg plus ECX
干预措施: Capecitabine (Drug)
Phase 2 Arm B
AMG 102 at 7.5mg/kg plus ECX
干预措施: Epirubicin (Drug)
Phase 2 Arm B
AMG 102 at 7.5mg/kg plus ECX
干预措施: AMG 102 (Drug)
Phase 2 Arm B
AMG 102 at 7.5mg/kg plus ECX
干预措施: Cisplatin (Drug)
Phase 2 Arm A
AMG 102 at 15mg/kg plus ECX
干预措施: Capecitabine (Drug)
Phase 2 Arm A
AMG 102 at 15mg/kg plus ECX
干预措施: Epirubicin (Drug)
Phase 2 Arm A
AMG 102 at 15mg/kg plus ECX
干预措施: AMG 102 (Drug)
Phase 2 Arm A
AMG 102 at 15mg/kg plus ECX
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression free survival (PFS), as measured by RECIST per local review
时间窗: Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.
次要结局
- Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only).(Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.)
- Incidence of adverse events, significant laboratory value changes form baseline and anti-AMG 102 antibody formation.(Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.)
- Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin with or without AMG 102(Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.)