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

RECRUITINGPhase 3Sponsored by Revolution Medicines, Inc.
Actively Recruiting
PhasePhase 3
SponsorRevolution Medicines, Inc.
Started2025-12-15
Est. completion2029-05-10
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →

NCT07252232

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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 medications.

Exclusion Criteria:

* 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.

Conditions6

CancerPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic CancerResectable Pancreatic Ductal Adenocarcinoma (PDAC)Resected Pancreatic Adenocarcinoma

Locations6 sites

Hartford Healthcare
Hartford, Connecticut, 06103
Jonathan Steinmetz(860) 972-4183jonathan.steinmetz@hhchealth.org
Community Health Network
Indianapolis, Indiana, 46250
Adam Norris(317) 621-3858anorris@ecommunity.com
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Marc Roth(816) 932-2677mroth@saint-lukes.org
Taylor Cancer Research Center
Maumee, Ohio, 43537
Principal Investigator567-402-4502sambrose@tcrcpt.org
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Heidi McKean605-322-6900heidi.mckean@avera.org

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