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

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

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07252232
Protocol IDs
RMC-6236-304 (primary)
NCI-2026-00629
Study Sponsor
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.

Objectives

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

  1. At least 18 years old and has provided informed consent.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
  4. Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.
  5. Must have completed most recent treatment within the past 12 weeks.
  6. Adequate organ function (bone marrow, liver, kidney, coagulation).
  7. Documented RAS mutation status.
  8. Able to take oral medications.

Treatment Sites in Georgia

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.