Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
NCT ID: NCT07252232
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2025-12-15
2030-07-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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daraxonrasib
study drug
daraxonrasib
oral tablets
SOC Observation
Patients randomized to the comparator control arm will receive SOC observation.
No interventions assigned to this group
Interventions
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daraxonrasib
oral tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Revolution Medicines, Inc.
INDUSTRY
Responsible Party
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Locations
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Hartford Healthcare
Hartford, Connecticut, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Pan American Oncology Trials, LLC
Río Piedras, Puerto Rico, Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Jonathan Steinmetz
Role: primary
Marc Roth
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Other Identifiers
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RMC-6236-304
Identifier Type: -
Identifier Source: org_study_id