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)
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
University of California, San Francisco
NOT_YET_RECRUITING
San Francisco
Connecticut
Hartford Healthcare
RECRUITING
Hartford
Indiana
Community Health Network
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center Research Institute, Inc.
RECRUITING
Lawrence
Maryland
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
RECRUITING
Baltimore
Missouri
Saint Luke's Cancer Institute
RECRUITING
Kansas City
New York
Columbia University Medical Center
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Taylor Cancer Research Center
RECRUITING
Maumee
South Dakota
Avera Cancer Institute
RECRUITING
Sioux Falls
Utah
University of Utah, Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Other Locations
Puerto Rico
Pan American Oncology Trials, LLC
RECRUITING
San Juan
United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre
RECRUITING
Birmingham
Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital
RECRUITING
London
The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London
RECRUITING
London
Contact Information
Primary
Revolution Medicines Study Director
medinfo@revmed.com
1-844-2-REVMED
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2030-07-10
Participants
Target number of participants: 500
Treatments
Experimental: daraxonrasib
study drug
No_intervention: SOC Observation
Patients randomized to the comparator control arm will receive SOC observation.
Related Therapeutic Areas
Sponsors
Leads: Revolution Medicines, Inc.