Trial summary: 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.
Status: OPEN - Recruiting
Trial identifier: NCT07491445
Sponsor: Revolution Medicines, Inc.
Phase: III
Diagnosis: Metastatic (Stage IV) pancreatic ductal adenocarcinoma.
Line of therapy: First line
Treatment: Daraxonrasib (oral RAS inhibitor) +/- gemcitabine/nab-paclitaxel chemotherapy (administered via IV)
  • Key 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.
  • Key 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.

RASolute 303

Locations: Epworth Richmond, Epworth Freemasons (East Melbourne), Epworth Eastern (Box Hill)

Epworth PI: A/Prof Sumitra Ananda

Jreissati Pancreatic Centre at Epworth 

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