2025-523495-23-00招募中3 期
RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2‑Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients with Resected Pancreatic Ductal Adenocarcinoma (PDAC)
Revolution Medicines Inc.31 个研究点 分布在 4 个国家目标入组 98 人开始时间: 2026年5月27日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 31
研究概览
简要总结
To compare the treatment effect of daraxonrasib versus standard of care observation in patients with resected pancreatic ductal adenocarcinoma (PDAC) following completion of neoadjuvant and/or adjuvant chemotherapy
研究设计
- 分配方式
- Na
- 主要目的
- Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old and has provided informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
- •Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.
- •Must have completed most recent treatment within the past 12 weeks.
- •Adequate organ function (bone marrow, liver, kidney, coagulation).
- •Documented RAS mutation status.
- •Able to take oral medications.
排除标准
- •Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
- •Any conditions that may affect the ability to take or absorb study drug.
- •Major surgery within 28 days prior to randomization.
- •Patient is unable or unwilling to comply with protocol-required study visits or procedures.
研究组 & 干预措施
DARAXONRASIB (RMC-6236), DARAXONRASIB (RMC-6236)
Test
干预措施: DARAXONRASIB (RMC-6236) (Drug)
研究者
Revolution Medicines Study Director
Scientific
Revolution Medicines Inc.
研究点 (31)
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