Study of Daraxonrasib for Metastatic Pancreatic Cancer

This study is testing a new targeted therapy called daraxonrasib for people with metastatic pancreatic cancer (cancer that has spread to other parts of the body). Researchers want to see if daraxonrasib, either alone or combined with standard chemotherapy (gemcitabine and nab-paclitaxel), is safer and more effective than chemotherapy alone. This study is for adults aged 18 and older with pancreatic adenocarcinoma that has spread, and you must have a documented RAS gene mutation status. The main goals are to see how long people live without their cancer growing (progression-free survival) and how long they live overall (overall survival), both measured for up to about two years. The current status of this study is unclear, and it plans to enroll around 900 participants.

Study design
This is a global, randomized, open-label, Phase 3 study. Participants will be randomly assigned to one of three treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival and overall survival will be measured for up to approximately two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07491445

Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

Recruiting
PHASE3Ages 18+InterventionalTreatment
Revolution Medicines, Inc.
~900 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:daraxonrasibgemcitabinenab-paclitaxel

At a glance

Recruiting sites
47 of 49 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over Up to approximately 2 years
+1 more outcome measured
Pancreatic Cancer
Pancreatic Cancer Metastatic
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Ductal Adenocarcinoma (PDAC)
Pancreatic Adenocarcinoma Metastatic
Pancreatic Adenocarcinoma
Pancreatic Adenosquamous Carcinoma

NCT07491445

Where you'd take part

This study runs at 49 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Calvary Mater Newcastle

    Waratah, New South Wales, Australiastudy coordinator listed

    Recruiting

  • Cancer Institute Hospital - Japan Foundation for Cancer Research

    Koto-Ku, Tokyo, Japanstudy coordinator listed

    Recruiting

  • CEPON - Centro de Pesquisa Oncologicas de Santa Catarina

    Florianópolis, Santa Catarina, Brazilstudy coordinator listed

    Recruiting

  • Curie Oncology Pte Ltd

    Singapore, Singaporestudy coordinator listed

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Duke University Medical Center

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Epworth HealthCare

    East Melbourne, Victoria, Australiastudy coordinator listed

    Recruiting

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Revolution Medicines Study Director
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Eligibility criteria

Inclusion

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

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.
  • Progression free survival (PFS)Up to approximately 2 years

    PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.

  • Overall survival (OS)Up to approximately 2 years

    OS is defined as the time from randomization until death from any cause.