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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 75
- 主要终点
- Disease-Free Survival (DFS) per Investigator
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.
详细描述
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.
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
- •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
SOC Observation
Patients randomized to the comparator control arm will receive SOC observation.
daraxonrasib
study drug
干预措施: daraxonrasib (Drug)
结局指标
主要结局
Disease-Free Survival (DFS) per Investigator
时间窗: Up to approximately 5 years
DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.
次要结局
- Overall survival (OS)(Up to approximately 5 years)
- DFS per blinded independent central review (BICR)(Up to approximately 5 years)
- DFS Rate at 1 year and 2 years(Up to approximately 2 years)
- OS rate at 1 year and 2 years(Up to approximately 2 years)
- Safety and tolerability of daraxonrasib(Up to approximately 5 years)
- Pharmacokinetics (PK)(Up to Cycle 4 Day 1 (Day 85))