Last updated 4 days ago
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
900 patients around the world
Available in Brazil, United States
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).
Revolution Medicines, Inc.
1Research sites
900Patients around the world
This study is for people with
Pancreatic cancer
Pancreatic ductal adenocarcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
Recruiting
StudyRASolute 303
SponsorRevolution Medicines, Inc.
Study typeInterventional
Conditions
Pancreatic cancerPancreatic ductal adenocarcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07491445
