RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Revolution Medicines, Inc.

Summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

Description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers

Detailed 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 confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease. * Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy. * Must have completed most recent treatment within the past 12 weeks. * Adequate organ function (bone marrow, liver, kidney, coagulation). * Documented RAS mutation status. * Able to take oral…

Locations (78)

Mayo Clinic
Phoenix, Arizona
bekaii-saab.tanios@mayo.edu 480-342-4800
HonorHealth Research Institute
Scottsdale, Arizona
UC San Diego Moores Cancer Center
La Jolla, California
sdad@health.ucsd.edu 858-822-5376
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California
naomi.geier@cshs.org 310-423-4693
University of California, Los Angeles
Los Angeles, California
mmanahan@mednet.ucla.edu 310-633-8400
Stanford Cancer Institute
Palo Alto, California
cblake1@stanford.edu 650-725-9895

Summary

Description

Eligibility

Interventions

Locations (78)