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Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic 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(s) of care (SOC) treatment.
Inclusion Criteria
At least 18 years old and has provided informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically or cytologically confirmed PDAC with metastatic disease.
Measurable disease per RECIST 1.1.
Adequate organ function (bone marrow, liver, kidney, coagulation)
Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
Able to take oral medications.
Exclusion Criteria
Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
History of or known central nervous system metastatic disease.
Any conditions that may affect the ability to take or absorb study treatment
Major surgery within 4 weeks prior to randomization.
Patient is unable or unwilling to comply with protocol-required study visits or procedures
Additional locations may be listed on ClinicalTrials.gov for NCT06625320.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
La Jolla
UC San Diego Moores Cancer Center
Status: Temporarily closed to accrual
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not Available
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Utah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not Available
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether
treatment with RMC-6236 will improve progression free survival (PFS) or overall survival
(OS) compared to Investigator's choice of standard of care chemotherapy in patients with
metastatic PDAC who were previously treated with one prior line of therapy with
5-fluorouracil (5-FU) based or gemcitabine-based regimen.
Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's
