TrialPath
Recruiting

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

NCT07491445 · Revolution Medicines, Inc.
In plain English

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Official title
RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma
About this study
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).
Eligibility criteria
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 design
Enrollment target: 900 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-09
Estimated completion: 2029-03
Last updated: 2026-06-03
Interventions
Drug: daraxonrasibDrug: gemcitabineDrug: nab-paclitaxel
Primary outcomes
  • Progression free survival (PFS) (Up to approximately 2 years)
  • Overall survival (OS) (Up to approximately 2 years)
Sponsor
Revolution Medicines, Inc. · industry
Contacts & investigators
ContactRevolution Medicines Study Director · contact · medinfo@revmed.com · 1-844-2-REVMED
All locations (5)
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterRecruiting
Baltimore, Maryland, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Comprehensive Cancer Centers of NevadaRecruiting
Henderson, Nevada, United States
Taylor Cancer Research CenterRecruiting
Maumee, Ohio, United States
Virginia Mason Medical CenterRecruiting
Seattle, Washington, United States
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma · TrialPath