A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 510
- 试验地点
- 48
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.
详细描述
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with atebimetinib plus a modified schedule of gemcitabine and nab-paclitaxel will improve overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.
Patients will be randomized to one of two arms: Arm A with atebimetinib + gemcitabine and nab-paclitaxel (modified dosing schedule) or Arm B with gemcitabine and nab-paclitaxel.
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
- •Must be ≥18 years of age
- •Must have confirmed diagnosis according to AJCC staging as follows:
- •Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Participants must be treatment naive as follows:
- •First-line PDAC participants will have received no previous systemic anti-cancer therapy
- •Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria
- •Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values
排除标准
- •Inability to swallow oral medications
- •Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
- •Participants with only locally advanced disease
- •Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases
研究组 & 干预措施
GnP
Standard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
干预措施: GnP (Drug)
Atebimetinib + mGnP
Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
干预措施: Atebimetinib (Drug)
Atebimetinib + mGnP
Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
干预措施: mGnP (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to approximately 2 years
The OS of participants with atebimetinib in combination with mGnP versus GnP
次要结局
- Progression Free Survival (PFS)(Up to approximately 2 years)
- Overall Response Rate (ORR)(Up to approximately 2 years)
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Incidence of Adverse Events (AEs)(Up to approximately 2 years)
- Quality of Life (QOL) with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Up to approximately 2 years)