What is the Purpose of this Study?
Primary Objective: To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC) versus standard of care observation on Disease Free Survival (DFS) per investigator Secondary Objectives: - To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC) versus standard of care observation on the following: o Overall survival (OS) (Key secondary objective) o Disease Free Survival per BICR (central imaging) o DFS rate at 1 year and 2 years (per investigator and BICR) o OS rate at 1 year and 2 years - To evaluate the safety and tolerability of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemo in patients with resected PDAC - To characterize the PK of daraxonrasib - Exploratory objectives
Eligibility
- * At least 18 years old and has provided informed consent.
- * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- * 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.
Where can I participate?
- CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi
- Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer
More about this Clinical Trial
What is the full name of this clinical trial?
RMC-6236-304: 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