A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine Versus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 65
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to determine whether the combination of MM-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1.
详细描述
This is a randomized, double-blind, placebo-controlled Phase 2 study of MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer. All patients will be initially screened for free IGF-1 status. Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients. Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise eligible will be followed in an observational group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are not eligible.
- •Patient must have received no prior radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
- •Blood sample sent for free IGF-1 testing
- •ECOG performance status (PS) of 0 or 1
排除标准
- •Patients who only present with localized disease
- •Patients with CNS malignancies (primary or metastatic)
- •Clinically significant cardiac disease
研究组 & 干预措施
Arm B (Comparator Arm)
Placebo in combination with nab-paclitaxel and gemcitabine
干预措施: Gemcitabine (Drug)
Arm A (Experimental Arm)
MM-141 in combination with nab-paclitaxel and gemcitabine
干预措施: Gemcitabine (Drug)
Arm A (Experimental Arm)
MM-141 in combination with nab-paclitaxel and gemcitabine
干预措施: MM-141 (Drug)
Arm B (Comparator Arm)
Placebo in combination with nab-paclitaxel and gemcitabine
干预措施: Placebo (Drug)
Arm A (Experimental Arm)
MM-141 in combination with nab-paclitaxel and gemcitabine
干预措施: Nab-Paclitaxel (Drug)
Arm B (Comparator Arm)
Placebo in combination with nab-paclitaxel and gemcitabine
干预措施: Nab-Paclitaxel (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Approximately 2 years
次要结局
- Duration of Response according to RECIST v1.1(Approximately 2 years)
- Rate of adverse events reported with the combination of MM-141 with nab-paclitaxel and gemcitabine versus the comparator arm(Approximately 2 years)
- Objective Response Rate according to RECIST v1.1(Approximately 2 years)
- Overall Survival(Approximately 2.5 years)