RASolute 304: A Phase III Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib versus Observation Following Curative Intent Therapy in Patients with Resected Pancreatic Ductal Adenocarcinoma (PDAC)
Categories (click each to see list of all clinical trials associated with that category): GI (ONC), Pancreatic Cancer Center of Excellence - PCCE (ONC)
Current Status: Not open
Phase: III
Principal Investigator: Klute, Kelsey
Contact Information:
Mahdi Hassan
mhassan@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07252232?term=NCT07252232&rank=1#participation-criteria
Summary
Primary objective: To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC versus standard of care observation on: DFS (per Investigator)
Key Secondary objective: To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC versus standard of care observation on: OS
Other Secondary Objectives:
To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC versus standard of care observation on: DFS (per BICR); DFS rate at 1 year and 2 years (per Investigator and BICR); OS rate at 1 year and 2 years
To evaluate the safety and tolerability oftreatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC
To characterize the PK of daraxonrasib