Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
Trial Status: active
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07252232.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not AvailableCalifornia
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not AvailableLos Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not AvailableSacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not AvailableSan Francisco
University of California San Francisco
Status: Active
Name Not AvailableFlorida
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: Active
Contact: Peter Joel Hosein
Email: phosein@miami.edu
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not AvailableMiami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not AvailablePlantation
UM Sylvester Comprehensive Cancer Center at Plantation
Status: Active
Contact: Peter Joel Hosein
Email: phosein@miami.edu
Georgia
Atlanta
Emory University Hospital Midtown
Status: Active
Name Not AvailableEmory University Hospital/Winship Cancer Institute
Status: Active
Name Not AvailableKansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not AvailableMaryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not AvailableMassachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not AvailableMassachusetts General Hospital Cancer Center
Status: Active
Name Not AvailableMinnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not AvailableNebraska
Omaha
University of Nebraska Medical Center
Status: Active
Name Not AvailableNew York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not AvailableMemorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableIcahn School of Medicine at Mount Sinai
Status: Active
Name Not AvailableLaura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not AvailableRochester
University of Rochester
Status: Active
Name Not AvailableNorth Carolina
Durham
Duke University Medical Center
Status: Active
Name Not AvailablePennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not AvailablePittsburgh
UPMC Hillman Cancer Center
Status: Active
Name Not AvailableTexas
Houston
UT MD Anderson Cancer Center
Status: Active
Name Not AvailableUtah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not AvailableWashington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not AvailableThis 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.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationRevolution Medicines, Inc.
- Primary IDRMC-6236-304
- Secondary IDsNCI-2026-00629
- ClinicalTrials.gov IDNCT07252232