Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 304)

September 11, 2026 updated by: Revolution Medicines, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Revolution Medicines Study Director
  • Phone Number: 1-844-2-REVMED
  • Email: medinfo@revmed.com

Study Locations

  • France
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
    • Cedex
      • Lille, Cedex, France, 59037
        • Recruiting
        • Hopital Claude Huriez - CHU Lille
      • Rennes, Cedex, France, 35042
        • Recruiting
        • CRLCC Eugene Marquis
    • Val-De- Marne
      • Villejuif, Val-De- Marne, France, 94804
        • Recruiting
        • Hôpital Paul Brousse
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Recruiting
        • Institut Gustave Roussy
  • Germany
      • Frankfurt, Germany, 60488
        • Recruiting
        • Krankenhaus Nordwest GmbH
        • Contact:
      • Heidelberg, Germany, 69120
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italy, 20141
        • Recruiting
        • IEO - Instituto Europeo di Oncologia
      • Padova, Italy, 35128
        • Recruiting
        • Iov - Istituto Oncologico Veneto Irccs
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
      • Verona, Italy, 37134
        • Recruiting
        • Centro Ricerche Cliniche di Verona s.r.l.
  • Japan
      • Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
      • Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
      • Tokyo, Japan, 135-8550
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Pan American Oncology Trials, LLC
        • Contact:
  • South Korea
      • Busan, South Korea, 49201
        • Recruiting
        • Dong-A University Hospital
        • Contact:
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron - VHIO
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Rocío Garcia Carbonero
          • Phone Number: 0034 913908003
      • Seville, Spain, 41013
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
        • Contact:
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Estibaliz San Martín González
          • Phone Number: 2712 0034 948255400
          • Email: esgonzalez@unav.es
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre
        • Contact:
      • Glasgow, United Kingdom, G22 0YN
        • Recruiting
        • Beatson West of Scotland Cancer Centre
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London
        • Contact:
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital
        • Contact:
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • HonorHealth Research Institute
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:
      • Los Angeles, California, United States, 90404
        • Recruiting
        • University of California, Los Angeles
        • Contact:
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Cancer at Cedars-Sinai Medical Center
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
    • Colorado
      • Lakewood, Colorado, United States, 80228
    • Connecticut
      • Hartford, Connecticut, United States, 06103
    • Florida
      • Jacksonville, Florida, United States, 32224
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center
        • Contact:
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Study Coordinator
          • Phone Number: 727-216-1143
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network
        • Contact:
    • Kansas
      • Lawrence, Kansas, United States, 66045
        • Recruiting
        • University of Kansas Medical Center Research Institute, Inc.
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital
        • Contact:
        • Contact:
          • Mike Pishvaian
          • Phone Number: 202-660-6500
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute (DFCI)
        • Contact:
          • Phone Number: 617-632-3000
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Cancer Center
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Cancer Institute
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
          • The Clinical Research Support Unit
          • Phone Number: 212-824-7391
          • Email: CRSU@mssm.edu
      • New York, New York, United States, 10032
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center
        • Contact:
        • Contact:
      • Rochester, New York, United States, 14642
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
    • Ohio
      • Maumee, Ohio, United States, 43537
        • Recruiting
        • Taylor Cancer Research Center
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania, Abramson Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - DFW
      • Houston, Texas, United States, 77030
      • Longview, Texas, United States, 75601
    • Utah
      • Salt Lake City, Utah, United States, 94112
        • Recruiting
        • University of Utah, Huntsman Cancer Institute
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchison Cancer Center
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital and the Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: daraxonrasib
study drug
Drug: daraxonrasib
oral tablets
No Intervention: SOC Observation
Patients randomized to the comparator control arm will receive SOC observation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS) per Investigator
Time Frame: Up to approximately 5 years
DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.
Up to approximately 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 5 years
OS is defined as the time from randomization until death from any cause.
Up to approximately 5 years
DFS per blinded independent central review (BICR)
Time Frame: Up to approximately 5 years
DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per RECIST v1.1 as assessed by BICR.
Up to approximately 5 years
DFS Rate at 1 year and 2 years
Time Frame: Up to approximately 2 years
DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively.
Up to approximately 2 years
OS rate at 1 year and 2 years
Time Frame: Up to approximately 2 years
OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively.
Up to approximately 2 years
Safety and tolerability of daraxonrasib
Time Frame: Up to approximately 5 years
Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests.
Up to approximately 5 years
Pharmacokinetics (PK)
Time Frame: Up to Cycle 4 Day 1 (Day 85)
Predose concentration of daraxonrasib
Up to Cycle 4 Day 1 (Day 85)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Revolution Medicines, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RMC-6236-304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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