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) (RASolute 304)

未提供0 个研究点目标入组 500 人开始时间: 待定

适应症

试验速览

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•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.

•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.

发起方

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