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

ConditionsPancreatic Cancer Pancreatic Cancer Metastatic PDAC PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Pancreatic Adenosquamous Carcinoma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorRevolution Medicines, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

daraxonrasib
gemcitabine
nab-paclitaxel

Treatment groups

900 Participants

are divided into 3 treatment groups

Locations

Japan

Wakayama Medical University Hospital641-8510, Wakayama Japan

Yamaguchi University Hospital755-8505, Yamaguchi Japan

United States

Florida

H Lee Moffitt Cancer Center and Research Institute33612, Tampa United States

Maryland

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center21287, Baltimore United States

Sponsors and collaborators

Revolution Medicines, Inc.

Lead sponsor

Source ClinicalTrials.gov