Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With Trastuzumab in Patients With HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 84
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
详细描述
This is a randomized, open Label, Phase 2 Study of MM-111 and Paclitaxel withTrastuzumab in Patients with HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy. Approximately 120 patients will be randomized in a 1:1 ratio between the experimental and comparator arms.
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
- •Patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach
- •Patients must have documentation of histologically or cytologically confirmed HER2 expression
- •Patients must be ≥18 years of age
- •Patients must have ECOG PS of 0, 1, or 2
- •Patients must have adequate hematologic status, renal and hepatic function
排除标准
- •Patients with known hypersensitivity to any of the components of MM-111
- •Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in Cremophor® EL
- •Patients with a known history of hypersensitivity to trastuzumab or any of its components (group 1 patients only)
- •Patients with an active infection or with an unexplained fever >38.5°C
研究组 & 干预措施
Arm 1a
MM-111 + Paclitaxel + Trastuzumab
干预措施: MM-111 (Drug)
Arm 1a
MM-111 + Paclitaxel + Trastuzumab
干预措施: Paclitaxel (Drug)
Arm 1a
MM-111 + Paclitaxel + Trastuzumab
干预措施: Trastuzumab (Drug)
Arm 1b
Paclitaxel + Trastuzumab
干预措施: Paclitaxel (Drug)
Arm 1b
Paclitaxel + Trastuzumab
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 30 months
Target and non-target lesion antitumor response and disease progression during treatment with each dosing regimen will be evaluated using the international criteria proposed by the RECIST v1.1. Disease status will be assessed every 8 weeks from the date of the first dose of any drug in a regimen.
次要结局
未报告次要终点