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Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

NCT07252232 · Revolution Medicines, Inc.
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Official title
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)
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-15
Estimated completion: 2030-07-10
Last updated: 2026-04-06
Interventions
Drug: daraxonrasib
Primary outcomes
  • Disease-Free Survival (DFS) per Investigator (Up to approximately 5 years)
Sponsor
Revolution Medicines, Inc. · industry
Contacts & investigators
ContactRevolution Medicines Study Director · contact · medinfo@revmed.com · 1-844-2-REVMED
All locations (15)
University of California, Los AngelesRecruiting
Los Angeles, California, United States
University of California, San FranciscoNot Yet Recruiting
San Francisco, California, United States
Hartford HealthcareRecruiting
Hartford, Connecticut, United States
Community Health NetworkRecruiting
Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center, Johns HopkinsRecruiting
Baltimore, Maryland, United States
Saint Luke's Cancer InstituteRecruiting
Kansas City, Missouri, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Taylor Cancer Research CenterRecruiting
Maumee, Ohio, United States
Avera Cancer InstituteRecruiting
Sioux Falls, South Dakota, United States
University of Utah, Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Pan American Oncology Trials, LLCRecruiting
San Juan, Puerto Rico, Puerto Rico
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical CentreRecruiting
Birmingham, United Kingdom
The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-LondonRecruiting
London, United Kingdom
Imperial College Healthcare NHS Foundation Trust, Hammersmith HospitalRecruiting
London, United Kingdom
Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) · TrialPath