Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

a study on Pancreatic Cancer Pancreatic Ductal Adenocarcinoma Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

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)

Details

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.

Keywords

Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma (PDAC), Resected Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, RAS, KRAS, NRAS, HRAS, RAS Wild-Type, RASolute, Resectable Pancreatic Ductal Adenocarcinoma, Resectable PDAC, RAS Mutation, Pancreatic Neoplasms, daraxonrasib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 medications.

You CAN'T join if...

  • Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  • 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.

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90404 United States
  • University of Utah, Huntsman Cancer Institute accepting new patients
    Salt Lake City Utah 94112 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
Links
Sign up for this study
ID
NCT07252232
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated
Contact us about this trial