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Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Trial Status: active
The purpose of this study is to evaluate the safety and efficacy of an investigational
RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy,
compared with standard of care (SOC) chemotherapy alone.
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 pancreatic adenocarcinoma.
Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
Documented RAS mutation status, either mutant or wild-type.
Measurable disease per RECIST v1.1.
Adequate organ function (bone marrow, liver, kidney, coagulation).
Able to take oral medications.
Exclusion Criteria
Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.
Active or known history of untreated central nervous system metastatic disease.
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 NCT07491445.
Locations matching your search criteria
United States
California
San Francisco
UCSF Medical Center-Mount Zion
Status: Approved
Name Not Available
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Texas
Houston
UT MD Anderson Cancer Center
Status: Active
Name Not Available
Utah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not Available
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether
treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and
nab-paclitaxel will improve progression-free survival and/or overall survival compared
with standard gemcitabine and nab-paclitaxel when given as first-line treatment in
patients with metastatic pancreatic adenocarcinoma.
Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib +
gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).
