Pancreatic CancerPhase 3RASolute 304NCT07252232
Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
A Phase 3 study testing daraxonrasib in people with Pancreatic Cancer and PDAC, run by Revolution Medicines, Inc. at 86 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- daraxonrasib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 86 sitesin 10 countries
- Study dates
- 15 Dec 2025to 10 Jul 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
86 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
86 sites in 10 countries
United States46 sites, 46 recruiting
- Recruiting
Piedmont Physicians Medical Oncology Atlanta
Atlanta, Georgia, 30318
Eyal Meiri, 404-425-1777, orrteam@piedmont.org
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Kathleen Coleman, 404-251-1278, kathleen.marie.coleman@emory.edu
- Recruiting
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital
Baltimore, Maryland, 21287
GI Clinical Trial Referrals, 410-614-3644, giclinicaltrials@jhmi.edu
Mike Pishvaian, 202-660-6500
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
Mehmet Akce, 205-934-2992, makce@uabmc.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215
617-632-3000
- Recruiting
Texas Oncology - DFW
Dallas, Texas, 75246
- Recruiting
University of Texas, Southwestern Medical Center
Dallas, Texas, 75390
Carrie Manwaring, 214-645-9685, Carrie.Manwaring@utsouthwestern.edu
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Recruiting
Hartford Healthcare
Hartford, Connecticut, 06103
Jonathan Steinmetz, 860-972-4183, jonathan.steinmetz@hhchealth.org
- Not yet recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Kim Ross, 713-794-1623, GIClinicalTrials@mdanderson.org
- Recruiting
Community Health Network
Indianapolis, Indiana, 46250
Adam Norris, 317-621-3858, anorris@ecommunity.com
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Hani Babiker, 520-626-7866, babiker.hani@mayo.edu
- Recruiting
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Marc Roth, 816-932-2677, mroth@saint-lukes.org
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92037
Shakeela Dad, 858-822-5376, sdad@health.ucsd.edu
- Recruiting
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228
Jennifer Hege, 303-388-4876, jennifer.hege@usoncology.com
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Ann Lovelace, 702-609-9460, ann.lovelace@usoncology.com
- Recruiting
University of Kansas Medical Center Research Institute, Inc.
Lawrence, Kansas, 66045
- Recruiting
Texas Oncology - Northeast Texas
Longview, Texas, 75601
Angie Smith, Angie.smith2@usoncology.com
- Recruiting
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, 90048
Naomi Geier, 310-423-4693, naomi.geier@cshs.org
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90404
Madeleine Manahan, 310-633-8400 ext. x19212, mmanahan@mednet.ucla.edu
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
Stephanie Ambrose, 567-402-4502, sambrose@tcrcpt.org
- Recruiting
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Yolanda Justal, 305-243-2647, yxj512@med.miami.edu
- Recruiting
Mount Sinai Braman Comprehensive Cancer Center
Miami Beach, Florida, 33140
Yvonne Enriquez-Nunez, 305-674-2625, Yvonne.Enriquez@msmc.com
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Dawn Carini, 414-805-0789, dcarini@mcw.edu
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Kassie DiOrio, 732-235-2135, kassie.diorio@rutgers.edu
- Recruiting
Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center
New York, New York, 10016
Mark Bond, 212-731-6120, Ct.gov@nyulangone.org
Jennifer Coffey, 212-731-6120, Ct.gov@nyulangone.org
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
The Clinical Research Support Unit, 212-824-7391, CRSU@mssm.edu
- Recruiting
Columbia University Medical Center
New York, New York, 10032
cancerclinicaltrials@cumc.columbia.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Eileen O'Reilly, 646-888-4182, oreillye@MSKCC.ORG
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
Stanford Cancer Institute
Palo Alto, California, 94304
Cassandra Blake, 650-725-9895, cblake1@stanford.edu
- Recruiting
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Tanios Bekaii-Saab, 480-342-4800, bekaii-saab.tanios@mayo.edu
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Debbie Diecks, 412-623-8364, diecksda@upmc.edu
- Recruiting
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Ryan Carr, 507-284-2511, carr.ryan@mayo.edu
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Richard Dunne, 585-275-4401, WCICTOResearch@URMC.Rochester.edu
- Recruiting
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
- Recruiting
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 94112
Susan Sherry, 801-585-3453, susan.sharry@hci.utah.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Kevin Lopez, 415-502-3310, Kevin.lopez@ucsf.edu
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
- Recruiting
Fred Hutchison Cancer Center
Seattle, Washington, 98109
Ridge Archer, 206-667-1392, rarcher@fredhutch.org
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Heidi McKean, 605-322-6900, heidi.mckean@avera.org
- Recruiting
Florida Cancer Specialists
St. Petersburg, Florida, 33701
Study Coordinator, 727-216-1143
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron - VHIO
Barcelona, 08035
Jordi Perera, 0034 932543454 ext. 1256, jperera@vhio.net
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Teresa Macarulla Mercadé, 0034 932275402, macarulla@clinic.cat
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Rocío Garcia Carbonero, 0034 913908003
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Estibaliz San Martín González, 0034 948255400 ext. 2712, esgonzalez@unav.es
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
Inmaculada Gallego Jimenez, 0034 955018613, inmaculada.gallego.jimenez.sspa@juntadeandalucia.es
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Lorena SazLluch, 0034 629260816, lsaz@incliva.es
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Roberto Pazo Cid, 0034 976765500, rpazo@salud.aragon.es
Italy6 sites, 6 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
- Recruiting
IEO - Instituto Europeo di Oncologia
Milan, 20141
- Recruiting
Azienda Ospedaliera Universitaria-Luigi Vanvitelli
Naples, 80131
- Recruiting
IOV - Istituto Oncologico Veneto IRCCS
Padova, 35128
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
- Recruiting
Centro Ricerche Cliniche di Verona s.r.l.
Verona, 37134
Japan6 sites, 6 recruiting
- Recruiting
National Cancer Center Hospital East
Chiba, 277-8577
Masafumi Ikeda, 81471331111, masikeda@east.ncc.go.jp
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
- Recruiting
Kyoto University Hospital
Kyoto, 606-8507
- Recruiting
National Cancer Center Hospital
Tokyo, 104-0045
- Recruiting
Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Masato Ozaka, masato.ozaka@jfcr.or.jp
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Makoto Ueno, kccmakoto23u@gmail.com
United Kingdom6 sites, 6 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre
Birmingham, B15 2TH
Shivan Shivakumar, 0121 371 3571, Shivan.Sivakumar@uhb.nhs.uk
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, G22 0YN
- Recruiting
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L7 8YA
- Recruiting
The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London
London, SW3 6JJ
Naureen Starling, 02078118460, gitrials@rmh.nhs.uk
- Recruiting
Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital
London, W12 0HS
Michela Cicchetti, 0203 313 8364, michela.cicchetti@nhs.ne
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
France5 sites, 5 recruiting
- Recruiting
Hopital Claude Huriez - CHU Lille
Lille, Cedex, 59037
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
- Recruiting
CRLCC Eugene Marquis
Rennes, Cedex, 35042
- Recruiting
Hôpital Paul Brousse
Villejuif, Val-De- Marne, 94804
- Recruiting
Institut Gustave Roussy
Villejuif, Val-de-Marne, 94805
South Korea4 sites, 4 recruiting
- Recruiting
Dong-A University Hospital
Busan, 49201
Ae ri Jang, 82512402576, dongahicrc33@naver.com
- Recruiting
Seoul National University Hospital
Seoul, 03080
Do-Yoon Oh, 82220720701, ohdoyoun@snu.ac.kr
- Recruiting
Asan Medical Center
Seoul, 05505
Changhoon Yoo, 82230101727, yooc@amc.seoul.kr
- Recruiting
Samsung Medical Center
Seoul, 06351
Hyangsuk Jeong, +82 2 3410 0955, hyangsuk.jeong@samsung.com
Germany3 sites, 3 recruiting
- Recruiting
Krankenhaus Nordwest GmbH
Frankfurt, 60488
Thorsten Oliver Götze, +49 69 7601 4420, Info.IKF@khnw.DE
- Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Christoph Springfeld, +49 6221 56 6857, christoph.springfeld@med.uni-heidelberg.de
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
Thomas Seufferlein, +49 731 500 44501, thomas.seufferlein@uniklinik-ulm.de
Canada2 sites, 2 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
- Recruiting
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, M5G 2M9
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Oncology Trials, LLC
San Juan, 00909
Principal Investigator, 787-407-3333, info@panoncologytrials.com
About this study
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)
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.
Read the 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.
- Conditions
- Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma (PDAC), Resected Pancreatic Adenocarcinoma
- Being tested
- daraxonrasib
- Keywords
- Pancreatic Cancer, PDAC, Pancreatic Ductal Adenocarcinoma, RAS, KRAS, NRAS, HRAS, RAS Wild-Type, RASolute, Resectable Pancreatic Ductal Adenocarcinoma, Resectable PDAC, Resected Pancreatic Adenocarcinoma, RAS Mutation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daraxonrasibDrug
oral tablets
| Study group | Role | What they receive |
|---|---|---|
| daraxonrasib | Experimental | study drug Receives: Drug: daraxonrasib |
| SOC Observation | No intervention | Patients randomized to the comparator control arm will receive SOC observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS) per Investigator
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.
Measured: Up to approximately 5 years
Secondary outcomes (6)
Overall survival (OS)
OS is defined as the time from randomization until death from any cause.
Measured: Up to approximately 5 years
DFS per blinded independent central review (BICR)
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.
Measured: Up to approximately 5 years
DFS Rate at 1 year and 2 years
DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively.
Measured: Up to approximately 2 years
OS rate at 1 year and 2 years
OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively.
Measured: Up to approximately 2 years
Safety and tolerability of daraxonrasib
Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests.
Measured: Up to approximately 5 years
Pharmacokinetics (PK)
Predose concentration of daraxonrasib
Measured: Up to Cycle 4 Day 1 (Day 85)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start15 Dec 2025
- Primary completion10 May 2029 (estimated)
- Study completion10 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Revolution Medicines, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Revolution Medicines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252232
- Sponsor's protocol ID
- RMC-6236-304
- Acronym
- RASolute 304
- Status last verified
- Aug 2026
- First submitted
- 13 Nov 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available