Studie av Daraxonrasib (RMC-6236) hos pasienter med resekert pankreasduktalcarcinom (PDAC) (RASolute 304)
21. oktober 2026 oppdatert av: Revolution Medicines, Inc.
RASolute 304: En fase 3 multicenter, åpen merket, randomisert, 2-arm studie av adjuvant Daraxonrasib versus standard observasjon etter fullført neoadjuvant og/eller adjuvant kjemoterapi hos pasienter med resekert pankreasduktalcarcinom (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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
500
Fase
- Fase 3
Utvidet tilgang
Godkjent for salg til publikum.
Se utvidet tilgangspost.
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Revolution Medicines Study Director
- Telefonnummer: 1-844-2-REVMED
- E-post: medinfo@revmed.com
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Centre - University Health Network
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Rekruttering
- McGill University Health Centre
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Alabama
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Birmingham, Alabama, Forente stater, 35249
- Rekruttering
- The University of Alabama at Birmingham
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Ta kontakt med:
- Mehmet Akce
- Telefonnummer: 205-934-2992
- E-post: makce@uabmc.edu
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Arizona
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Phoenix, Arizona, Forente stater, 85054
- Rekruttering
- Mayo Clinic
-
Ta kontakt med:
- Tanios Bekaii-Saab
- Telefonnummer: 480-342-4800
- E-post: bekaii-saab.tanios@mayo.edu
-
Scottsdale, Arizona, Forente stater, 85258
- Rekruttering
- HonorHealth Research Institute
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California
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La Jolla, California, Forente stater, 92037
- Rekruttering
- UC San Diego Moores Cancer Center
-
Ta kontakt med:
- Shakeela Dad
- Telefonnummer: 858-822-5376
- E-post: sdad@health.ucsd.edu
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Los Angeles, California, Forente stater, 90404
- Rekruttering
- University of California, Los Angeles
-
Ta kontakt med:
- Madeleine Manahan
- Telefonnummer: x19212 310-633-8400
- E-post: mmanahan@mednet.ucla.edu
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Los Angeles, California, Forente stater, 90048
- Rekruttering
- Cedars-Sinai Cancer at Cedars-Sinai Medical Center
-
Ta kontakt med:
- Naomi Geier
- Telefonnummer: 310-423-4693
- E-post: naomi.geier@cshs.org
-
Palo Alto, California, Forente stater, 94304
- Rekruttering
- Stanford Cancer Institute
-
Ta kontakt med:
- Cassandra Blake
- Telefonnummer: 650-725-9895
- E-post: cblake1@stanford.edu
-
Sacramento, California, Forente stater, 95817
- Rekruttering
- University of California, Davis Comprehensive Cancer Center
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San Francisco, California, Forente stater, 94143
- Rekruttering
- University of California, San Francisco
-
Ta kontakt med:
- Kevin Lopez
- Telefonnummer: 415-502-3310
- E-post: Kevin.lopez@ucsf.edu
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Colorado
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Lakewood, Colorado, Forente stater, 80228
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
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Ta kontakt med:
- Jennifer Hege
- Telefonnummer: 303-388-4876
- E-post: jennifer.hege@usoncology.com
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Connecticut
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Hartford, Connecticut, Forente stater, 06103
- Rekruttering
- Hartford Healthcare
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Ta kontakt med:
- Jonathan Steinmetz
- Telefonnummer: 860-972-4183
- E-post: jonathan.steinmetz@hhchealth.org
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Rekruttering
- Mayo Clinic
-
Ta kontakt med:
- Hani Babiker
- Telefonnummer: 520-626-7866
- E-post: babiker.hani@mayo.edu
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Miami, Florida, Forente stater, 33136
- Rekruttering
- University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center
-
Ta kontakt med:
- Yolanda Justal
- Telefonnummer: 305-243-2647
- E-post: yxj512@med.miami.edu
-
Miami Beach, Florida, Forente stater, 33140
- Rekruttering
- Mount Sinai Braman Comprehensive Cancer Center
-
Ta kontakt med:
- Yvonne Enriquez-Nunez
- Telefonnummer: 305-674-2625
- E-post: Yvonne.Enriquez@msmc.com
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St. Petersburg, Florida, Forente stater, 33701
- Rekruttering
- Florida Cancer Specialists
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 727-216-1143
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Rekruttering
- Winship Cancer Institute, Emory University
-
Ta kontakt med:
- Kathleen Coleman
- Telefonnummer: 404-251-1278
- E-post: kathleen.marie.coleman@emory.edu
-
Atlanta, Georgia, Forente stater, 30318
- Rekruttering
- Piedmont Physicians Medical Oncology Atlanta
-
Ta kontakt med:
- Eyal Meiri
- Telefonnummer: 404-425-1777
- E-post: orrteam@piedmont.org
-
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Indiana
-
Indianapolis, Indiana, Forente stater, 46250
- Rekruttering
- Community Health Network
-
Ta kontakt med:
- Adam Norris
- Telefonnummer: 317-621-3858
- E-post: anorris@ecommunity.com
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Kansas
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Lawrence, Kansas, Forente stater, 66045
- Rekruttering
- University of Kansas Medical Center Research Institute, Inc.
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Maryland
-
Baltimore, Maryland, Forente stater, 21287
- Rekruttering
- Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital
-
Ta kontakt med:
- GI Clinical Trial Referrals
- Telefonnummer: 410-614-3644
- E-post: giclinicaltrials@jhmi.edu
-
Ta kontakt med:
- Mike Pishvaian
- Telefonnummer: 202-660-6500
-
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Rekruttering
- Massachusetts General Hospital
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Boston, Massachusetts, Forente stater, 02215
- Rekruttering
- Dana Farber Cancer Institute (DFCI)
-
Ta kontakt med:
- Telefonnummer: 617-632-3000
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Rekruttering
- Mayo Clinic Cancer Center
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Ta kontakt med:
- Ryan Carr
- Telefonnummer: 507-284-2511
- E-post: carr.ryan@mayo.edu
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- Rekruttering
- Saint Luke's Cancer Institute
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Ta kontakt med:
- Marc Roth
- Telefonnummer: 816-932-2677
- E-post: mroth@saint-lukes.org
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Nebraska
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Omaha, Nebraska, Forente stater, 68198
- Rekruttering
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forente stater, 89169
- Rekruttering
- Comprehensive Cancer Centers of Nevada
-
Ta kontakt med:
- Ann Lovelace
- Telefonnummer: 702-609-9460
- E-post: ann.lovelace@usoncology.com
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New Jersey
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New Brunswick, New Jersey, Forente stater, 08901
- Rekruttering
- Rutgers Cancer Institute
-
Ta kontakt med:
- Kassie DiOrio
- Telefonnummer: 732-235-2135
- E-post: kassie.diorio@rutgers.edu
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New York
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New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
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Ta kontakt med:
- Eileen O'Reilly
- Telefonnummer: 646-888-4182
- E-post: oreillye@MSKCC.ORG
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New York, New York, Forente stater, 10029
- Rekruttering
- Icahn School of Medicine at Mount Sinai
-
Ta kontakt med:
- The Clinical Research Support Unit
- Telefonnummer: 212-824-7391
- E-post: CRSU@mssm.edu
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New York, New York, Forente stater, 10032
- Rekruttering
- Columbia University Medical Center
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Ta kontakt med:
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New York, New York, Forente stater, 10016
- Rekruttering
- Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center
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Ta kontakt med:
- Mark Bond
- Telefonnummer: 212-731-6120
- E-post: Ct.gov@nyulangone.org
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Ta kontakt med:
- Jennifer Coffey
- Telefonnummer: 212-731-6120
- E-post: Ct.gov@nyulangone.org
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Rochester, New York, Forente stater, 14642
- Rekruttering
- University of Rochester Medical Center
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Ta kontakt med:
- Richard Dunne
- Telefonnummer: 585-275-4401
- E-post: WCICTOResearch@URMC.Rochester.edu
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Rekruttering
- Duke Cancer Center
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Ohio
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Maumee, Ohio, Forente stater, 43537
- Rekruttering
- Taylor Cancer Research Center
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Ta kontakt med:
- Stephanie Ambrose
- Telefonnummer: 567-402-4502
- E-post: sambrose@tcrcpt.org
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- University of Pennsylvania, Abramson Cancer Center
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Pittsburgh, Pennsylvania, Forente stater, 15232
- Rekruttering
- UPMC Hillman Cancer Center
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Ta kontakt med:
- Debbie Diecks
- Telefonnummer: 412-623-8364
- E-post: diecksda@upmc.edu
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South Dakota
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Sioux Falls, South Dakota, Forente stater, 57105
- Rekruttering
- Avera Cancer Institute
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Ta kontakt med:
- Heidi McKean
- Telefonnummer: 605-322-6900
- E-post: heidi.mckean@avera.org
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- SCRI Oncology Partners
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Texas
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Dallas, Texas, Forente stater, 75390
- Rekruttering
- University of Texas, Southwestern Medical Center
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Ta kontakt med:
- Carrie Manwaring
- Telefonnummer: 214-645-9685
- E-post: Carrie.Manwaring@utsouthwestern.edu
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Dallas, Texas, Forente stater, 75246
- Rekruttering
- Texas Oncology - DFW
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Houston, Texas, Forente stater, 77030
- Har ikke rekruttert ennå
- University of Texas MD Anderson Cancer Center
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Ta kontakt med:
- Kim Ross
- Telefonnummer: 713-794-1623
- E-post: GIClinicalTrials@mdanderson.org
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Longview, Texas, Forente stater, 75601
- Rekruttering
- Texas Oncology - Northeast Texas
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Ta kontakt med:
- Angie Smith
- E-post: Angie.smith2@usoncology.com
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Utah
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Salt Lake City, Utah, Forente stater, 94112
- Rekruttering
- University of Utah, Huntsman Cancer Institute
-
Ta kontakt med:
- Susan Sherry
- Telefonnummer: 801-585-3453
- E-post: susan.sharry@hci.utah.edu
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Virginia
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Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Virginia Cancer Specialists
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Washington
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Seattle, Washington, Forente stater, 98109
- Rekruttering
- Fred Hutchison Cancer Center
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Ta kontakt med:
- Ridge Archer
- Telefonnummer: 206-667-1392
- E-post: rarcher@fredhutch.org
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Rekruttering
- Froedtert Hospital and the Medical College of Wisconsin
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Ta kontakt med:
- Dawn Carini
- Telefonnummer: 414-805-0789
- E-post: dcarini@mcw.edu
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Marseille, Frankrike, 13009
- Rekruttering
- Institut Paoli Calmettes
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Cedex
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Lille, Cedex, Frankrike, 59037
- Rekruttering
- Hopital Claude Huriez - CHU Lille
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Rennes, Cedex, Frankrike, 35042
- Rekruttering
- CRLCC Eugene Marquis
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Val-De- Marne
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Villejuif, Val-De- Marne, Frankrike, 94804
- Rekruttering
- Hôpital Paul Brousse
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Val-de-Marne
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Villejuif, Val-de-Marne, Frankrike, 94805
- Rekruttering
- Institut Gustave Roussy
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-
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Milan, Italia, 20141
- Rekruttering
- IEO - Instituto Europeo di Oncologia
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Milan, Italia, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Naples, Italia, 80131
- Rekruttering
- Azienda Ospedaliera Universitaria-Luigi Vanvitelli
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Padova, Italia, 35128
- Rekruttering
- IOV - Istituto Oncologico Veneto IRCCS
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Pisa, Italia, 56126
- Rekruttering
- Azienda Ospedaliero Universitaria Pisana
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Verona, Italia, 37134
- Rekruttering
- Centro Ricerche Cliniche di Verona s.r.l.
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Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
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Ta kontakt med:
- Masafumi Ikeda
- Telefonnummer: 81471331111
- E-post: masikeda@east.ncc.go.jp
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Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital
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Kyoto, Japan, 606-8507
- Rekruttering
- Kyoto University Hospital
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Tokyo, Japan, 104-0045
- Rekruttering
- National Cancer Center Hospital
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Tokyo, Japan, 135-8550
- Rekruttering
- Cancer Institute Hospital of JFCR
-
Ta kontakt med:
- Masato Ozaka
- E-post: masato.ozaka@jfcr.or.jp
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-8515
- Rekruttering
- Kanagawa Cancer Center
-
Ta kontakt med:
- Makoto Ueno
- E-post: kccmakoto23u@gmail.com
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San Juan, Puerto Rico, 00909
- Rekruttering
- Pan American Oncology Trials, LLC
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Ta kontakt med:
- Principal Investigator
- Telefonnummer: 787-407-3333
- E-post: info@panoncologytrials.com
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-
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Barcelona, Spania, 08036
- Rekruttering
- Hospital Clinic de Barcelona
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Ta kontakt med:
- Teresa Macarulla Mercadé
- Telefonnummer: 0034 932275402
- E-post: macarulla@clinic.cat
-
Barcelona, Spania, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebron - VHIO
-
Ta kontakt med:
- Jordi Perera
- Telefonnummer: 0034 932543454 ext. 1256
- E-post: jperera@vhio.net
-
Madrid, Spania, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Ta kontakt med:
- Rocío Garcia Carbonero
- Telefonnummer: 0034 913908003
-
Seville, Spania, 41013
- Rekruttering
- Hospital Universitario Virgen del Rocio
-
Ta kontakt med:
- Inmaculada Gallego Jimenez
- Telefonnummer: 0034 955018613
- E-post: inmaculada.gallego.jimenez.sspa@juntadeandalucia.es
-
Valencia, Spania, 46010
- Rekruttering
- Hospital Clinico Universitario de Valencia
-
Ta kontakt med:
- Lorena SazLluch
- Telefonnummer: 0034 629260816
- E-post: lsaz@incliva.es
-
Zaragoza, Spania, 50009
- Rekruttering
- Hospital Universitario Miguel Servet
-
Ta kontakt med:
- Roberto Pazo Cid
- Telefonnummer: 0034 976765500
- E-post: rpazo@salud.aragon.es
-
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Navarre
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Pamplona, Navarre, Spania, 31008
- Rekruttering
- Clinica Universidad de Navarra
-
Ta kontakt med:
- Estibaliz San Martín González
- Telefonnummer: 2712 0034 948255400
- E-post: esgonzalez@unav.es
-
-
-
-
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Birmingham, Storbritannia, B15 2TH
- Rekruttering
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre
-
Ta kontakt med:
- Shivan Shivakumar
- Telefonnummer: 0121 371 3571
- E-post: Shivan.Sivakumar@uhb.nhs.uk
-
Glasgow, Storbritannia, G22 0YN
- Rekruttering
- Beatson West of Scotland Cancer Centre
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Liverpool, Storbritannia, L7 8YA
- Rekruttering
- Clatterbridge Cancer Centre NHS Foundation Trust
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London, Storbritannia, SW3 6JJ
- Rekruttering
- The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London
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Ta kontakt med:
- Naureen Starling
- Telefonnummer: 02078118460
- E-post: gitrials@rmh.nhs.uk
-
London, Storbritannia, W12 0HS
- Rekruttering
- Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital
-
Ta kontakt med:
- Michela Cicchetti
- Telefonnummer: 0203 313 8364
- E-post: michela.cicchetti@nhs.ne
-
Manchester, Storbritannia, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
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-
-
-
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Busan, Sør -Korea, 49201
- Rekruttering
- Dong-A University Hospital
-
Ta kontakt med:
- Ae ri Jang
- Telefonnummer: 82512402576
- E-post: dongahicrc33@naver.com
-
Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center
-
Ta kontakt med:
- Changhoon Yoo
- Telefonnummer: 82230101727
- E-post: yooc@amc.seoul.kr
-
Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital
-
Ta kontakt med:
- Do-Yoon Oh
- Telefonnummer: 82220720701
- E-post: ohdoyoun@snu.ac.kr
-
Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center
-
Ta kontakt med:
- Hyangsuk Jeong
- Telefonnummer: +82 2 3410 0955
- E-post: hyangsuk.jeong@samsung.com
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-
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-
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Frankfurt, Tyskland, 60488
- Rekruttering
- Krankenhaus Nordwest GmbH
-
Ta kontakt med:
- Thorsten Oliver Götze
- Telefonnummer: +49 69 7601 4420
- E-post: Info.IKF@khnw.DE
-
Heidelberg, Tyskland, 69120
- Rekruttering
- Universitaetsklinikum Heidelberg
-
Ta kontakt med:
- Christoph Springfeld
- Telefonnummer: +49 6221 56 6857
- E-post: christoph.springfeld@med.uni-heidelberg.de
-
Ulm, Tyskland, 89081
- Rekruttering
- Universitaetsklinikum Ulm
-
Ta kontakt med:
- Thomas Seufferlein
- Telefonnummer: +49 731 500 44501
- E-post: thomas.seufferlein@uniklinik-ulm.de
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: daraxonrasib
study drug |
oral tablets |
|
Ingen inngripen: SOC Observation
Patients randomized to the comparator control arm will receive SOC observation. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease-Free Survival (DFS) per Investigator
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival (OS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Up to Cycle 4 Day 1 (Day 85)
|
Predose concentration of daraxonrasib |
Up to Cycle 4 Day 1 (Day 85)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. desember 2025
Primær fullføring (Antatt)
10. mai 2029
Studiet fullført (Antatt)
10. juli 2030
Datoer for studieregistrering
Først innsendt
13. november 2025
Først innsendt som oppfylte QC-kriteriene
18. november 2025
Først lagt ut (Faktiske)
26. november 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. oktober 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RMC-6236-304
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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