Undersøgelse af Daraxonrasib (RMC-6236) hos patienter med resekeret pancreatisk duktalt adenokarcinom (PDAC) (RASolute 304)
21. oktober 2026 opdateret af: Revolution Medicines, Inc.
RASolute 304: En fase 3 multicenter, åben-label, randomiseret, 2-armet undersøgelse af adjuvant Daraxonrasib versus standard observationsbehandling efter afslutning af neoadjuvant og/eller adjuvant kemoterapi hos patienter med reseceret pancreatisk duktusadenokarcinom (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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
500
Fase
- Fase 3
Udvidet adgang
Godkendt til salg til offentligheden.
Se udvidet adgangsregistrering.
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Revolution Medicines Study Director
- Telefonnummer: 1-844-2-REVMED
- E-mail: medinfo@revmed.com
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Centre - University Health Network
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3J1
- Rekruttering
- McGill University Health Centre
-
-
-
-
-
Birmingham, Det Forenede Kongerige, B15 2TH
- Rekruttering
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre
-
Kontakt:
- Shivan Shivakumar
- Telefonnummer: 0121 371 3571
- E-mail: Shivan.Sivakumar@uhb.nhs.uk
-
Glasgow, Det Forenede Kongerige, G22 0YN
- Rekruttering
- Beatson West of Scotland Cancer Centre
-
Liverpool, Det Forenede Kongerige, L7 8YA
- Rekruttering
- Clatterbridge Cancer Centre NHS Foundation Trust
-
London, Det Forenede Kongerige, SW3 6JJ
- Rekruttering
- The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London
-
Kontakt:
- Naureen Starling
- Telefonnummer: 02078118460
- E-mail: gitrials@rmh.nhs.uk
-
London, Det Forenede Kongerige, W12 0HS
- Rekruttering
- Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital
-
Kontakt:
- Michela Cicchetti
- Telefonnummer: 0203 313 8364
- E-mail: michela.cicchetti@nhs.ne
-
Manchester, Det Forenede Kongerige, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35249
- Rekruttering
- The University of Alabama at Birmingham
-
Kontakt:
- Mehmet Akce
- Telefonnummer: 205-934-2992
- E-mail: makce@uabmc.edu
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85054
- Rekruttering
- Mayo Clinic
-
Kontakt:
- Tanios Bekaii-Saab
- Telefonnummer: 480-342-4800
- E-mail: bekaii-saab.tanios@mayo.edu
-
Scottsdale, Arizona, Forenede Stater, 85258
- Rekruttering
- HonorHealth Research Institute
-
-
California
-
La Jolla, California, Forenede Stater, 92037
- Rekruttering
- UC San Diego Moores Cancer Center
-
Kontakt:
- Shakeela Dad
- Telefonnummer: 858-822-5376
- E-mail: sdad@health.ucsd.edu
-
Los Angeles, California, Forenede Stater, 90404
- Rekruttering
- University of California, Los Angeles
-
Kontakt:
- Madeleine Manahan
- Telefonnummer: x19212 310-633-8400
- E-mail: mmanahan@mednet.ucla.edu
-
Los Angeles, California, Forenede Stater, 90048
- Rekruttering
- Cedars-Sinai Cancer at Cedars-Sinai Medical Center
-
Kontakt:
- Naomi Geier
- Telefonnummer: 310-423-4693
- E-mail: naomi.geier@cshs.org
-
Palo Alto, California, Forenede Stater, 94304
- Rekruttering
- Stanford Cancer Institute
-
Kontakt:
- Cassandra Blake
- Telefonnummer: 650-725-9895
- E-mail: cblake1@stanford.edu
-
Sacramento, California, Forenede Stater, 95817
- Rekruttering
- University of California, Davis Comprehensive Cancer Center
-
San Francisco, California, Forenede Stater, 94143
- Rekruttering
- University of California, San Francisco
-
Kontakt:
- Kevin Lopez
- Telefonnummer: 415-502-3310
- E-mail: Kevin.lopez@ucsf.edu
-
-
Colorado
-
Lakewood, Colorado, Forenede Stater, 80228
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
-
Kontakt:
- Jennifer Hege
- Telefonnummer: 303-388-4876
- E-mail: jennifer.hege@usoncology.com
-
-
Connecticut
-
Hartford, Connecticut, Forenede Stater, 06103
- Rekruttering
- Hartford Healthcare
-
Kontakt:
- Jonathan Steinmetz
- Telefonnummer: 860-972-4183
- E-mail: jonathan.steinmetz@hhchealth.org
-
-
Florida
-
Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic
-
Kontakt:
- Hani Babiker
- Telefonnummer: 520-626-7866
- E-mail: babiker.hani@mayo.edu
-
Miami, Florida, Forenede Stater, 33136
- Rekruttering
- University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center
-
Kontakt:
- Yolanda Justal
- Telefonnummer: 305-243-2647
- E-mail: yxj512@med.miami.edu
-
Miami Beach, Florida, Forenede Stater, 33140
- Rekruttering
- Mount Sinai Braman Comprehensive Cancer Center
-
Kontakt:
- Yvonne Enriquez-Nunez
- Telefonnummer: 305-674-2625
- E-mail: Yvonne.Enriquez@msmc.com
-
St. Petersburg, Florida, Forenede Stater, 33701
- Rekruttering
- Florida Cancer Specialists
-
Kontakt:
- Study Coordinator
- Telefonnummer: 727-216-1143
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Winship Cancer Institute, Emory University
-
Kontakt:
- Kathleen Coleman
- Telefonnummer: 404-251-1278
- E-mail: kathleen.marie.coleman@emory.edu
-
Atlanta, Georgia, Forenede Stater, 30318
- Rekruttering
- Piedmont Physicians Medical Oncology Atlanta
-
Kontakt:
- Eyal Meiri
- Telefonnummer: 404-425-1777
- E-mail: orrteam@piedmont.org
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46250
- Rekruttering
- Community Health Network
-
Kontakt:
- Adam Norris
- Telefonnummer: 317-621-3858
- E-mail: anorris@ecommunity.com
-
-
Kansas
-
Lawrence, Kansas, Forenede Stater, 66045
- Rekruttering
- University of Kansas Medical Center Research Institute, Inc.
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21287
- Rekruttering
- Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital
-
Kontakt:
- GI Clinical Trial Referrals
- Telefonnummer: 410-614-3644
- E-mail: giclinicaltrials@jhmi.edu
-
Kontakt:
- Mike Pishvaian
- Telefonnummer: 202-660-6500
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Massachusetts General Hospital
-
Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Dana Farber Cancer Institute (DFCI)
-
Kontakt:
- Telefonnummer: 617-632-3000
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Rekruttering
- Mayo Clinic Cancer Center
-
Kontakt:
- Ryan Carr
- Telefonnummer: 507-284-2511
- E-mail: carr.ryan@mayo.edu
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64111
- Rekruttering
- Saint Luke's Cancer Institute
-
Kontakt:
- Marc Roth
- Telefonnummer: 816-932-2677
- E-mail: mroth@saint-lukes.org
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68198
- Rekruttering
- University of Nebraska Medical Center
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89169
- Rekruttering
- Comprehensive Cancer Centers of Nevada
-
Kontakt:
- Ann Lovelace
- Telefonnummer: 702-609-9460
- E-mail: ann.lovelace@usoncology.com
-
-
New Jersey
-
New Brunswick, New Jersey, Forenede Stater, 08901
- Rekruttering
- Rutgers Cancer Institute
-
Kontakt:
- Kassie DiOrio
- Telefonnummer: 732-235-2135
- E-mail: kassie.diorio@rutgers.edu
-
-
New York
-
New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
-
Kontakt:
- Eileen O'Reilly
- Telefonnummer: 646-888-4182
- E-mail: oreillye@MSKCC.ORG
-
New York, New York, Forenede Stater, 10029
- Rekruttering
- Icahn School of Medicine at Mount Sinai
-
Kontakt:
- The Clinical Research Support Unit
- Telefonnummer: 212-824-7391
- E-mail: CRSU@mssm.edu
-
New York, New York, Forenede Stater, 10032
- Rekruttering
- Columbia University Medical Center
-
Kontakt:
-
New York, New York, Forenede Stater, 10016
- Rekruttering
- Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center
-
Kontakt:
- Mark Bond
- Telefonnummer: 212-731-6120
- E-mail: Ct.gov@nyulangone.org
-
Kontakt:
- Jennifer Coffey
- Telefonnummer: 212-731-6120
- E-mail: Ct.gov@nyulangone.org
-
Rochester, New York, Forenede Stater, 14642
- Rekruttering
- University of Rochester Medical Center
-
Kontakt:
- Richard Dunne
- Telefonnummer: 585-275-4401
- E-mail: WCICTOResearch@URMC.Rochester.edu
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke Cancer Center
-
-
Ohio
-
Maumee, Ohio, Forenede Stater, 43537
- Rekruttering
- Taylor Cancer Research Center
-
Kontakt:
- Stephanie Ambrose
- Telefonnummer: 567-402-4502
- E-mail: sambrose@tcrcpt.org
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- University of Pennsylvania, Abramson Cancer Center
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- Rekruttering
- UPMC Hillman Cancer Center
-
Kontakt:
- Debbie Diecks
- Telefonnummer: 412-623-8364
- E-mail: diecksda@upmc.edu
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Rekruttering
- Avera Cancer Institute
-
Kontakt:
- Heidi McKean
- Telefonnummer: 605-322-6900
- E-mail: heidi.mckean@avera.org
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- SCRI Oncology Partners
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75390
- Rekruttering
- University of Texas, Southwestern Medical Center
-
Kontakt:
- Carrie Manwaring
- Telefonnummer: 214-645-9685
- E-mail: Carrie.Manwaring@utsouthwestern.edu
-
Dallas, Texas, Forenede Stater, 75246
- Rekruttering
- Texas Oncology - DFW
-
Houston, Texas, Forenede Stater, 77030
- Ikke rekrutterer endnu
- University of Texas MD Anderson Cancer Center
-
Kontakt:
- Kim Ross
- Telefonnummer: 713-794-1623
- E-mail: GIClinicalTrials@mdanderson.org
-
Longview, Texas, Forenede Stater, 75601
- Rekruttering
- Texas Oncology - Northeast Texas
-
Kontakt:
- Angie Smith
- E-mail: Angie.smith2@usoncology.com
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 94112
- Rekruttering
- University of Utah, Huntsman Cancer Institute
-
Kontakt:
- Susan Sherry
- Telefonnummer: 801-585-3453
- E-mail: susan.sharry@hci.utah.edu
-
-
Virginia
-
Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Virginia Cancer Specialists
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98109
- Rekruttering
- Fred Hutchison Cancer Center
-
Kontakt:
- Ridge Archer
- Telefonnummer: 206-667-1392
- E-mail: rarcher@fredhutch.org
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Rekruttering
- Froedtert Hospital and the Medical College of Wisconsin
-
Kontakt:
- Dawn Carini
- Telefonnummer: 414-805-0789
- E-mail: dcarini@mcw.edu
-
-
-
-
-
Marseille, Frankrig, 13009
- Rekruttering
- Institut Paoli Calmettes
-
-
Cedex
-
Lille, Cedex, Frankrig, 59037
- Rekruttering
- Hopital Claude Huriez - CHU Lille
-
Rennes, Cedex, Frankrig, 35042
- Rekruttering
- CRLCC Eugene Marquis
-
-
Val-De- Marne
-
Villejuif, Val-De- Marne, Frankrig, 94804
- Rekruttering
- Hôpital Paul Brousse
-
-
Val-de-Marne
-
Villejuif, Val-de-Marne, Frankrig, 94805
- Rekruttering
- Institut Gustave Roussy
-
-
-
-
-
Milan, Italien, 20141
- Rekruttering
- IEO - Instituto Europeo di Oncologia
-
Milan, Italien, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
Naples, Italien, 80131
- Rekruttering
- Azienda Ospedaliera Universitaria-Luigi Vanvitelli
-
Padova, Italien, 35128
- Rekruttering
- IOV - Istituto Oncologico Veneto IRCCS
-
Pisa, Italien, 56126
- Rekruttering
- Azienda Ospedaliero Universitaria Pisana
-
Verona, Italien, 37134
- Rekruttering
- Centro Ricerche Cliniche di Verona s.r.l.
-
-
-
-
-
Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
-
Kontakt:
- Masafumi Ikeda
- Telefonnummer: 81471331111
- E-mail: masikeda@east.ncc.go.jp
-
Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital
-
Kyoto, Japan, 606-8507
- Rekruttering
- Kyoto University Hospital
-
Tokyo, Japan, 104-0045
- Rekruttering
- National Cancer Center Hospital
-
Tokyo, Japan, 135-8550
- Rekruttering
- Cancer Institute Hospital of JFCR
-
Kontakt:
- Masato Ozaka
- E-mail: masato.ozaka@jfcr.or.jp
-
-
Kanagawa
-
Yokohama, Kanagawa, Japan, 241-8515
- Rekruttering
- Kanagawa Cancer Center
-
Kontakt:
- Makoto Ueno
- E-mail: kccmakoto23u@gmail.com
-
-
-
-
-
San Juan, Puerto Rico, 00909
- Rekruttering
- Pan American Oncology Trials, LLC
-
Kontakt:
- Principal Investigator
- Telefonnummer: 787-407-3333
- E-mail: info@panoncologytrials.com
-
-
-
-
-
Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Kontakt:
- Teresa Macarulla Mercadé
- Telefonnummer: 0034 932275402
- E-mail: macarulla@clinic.cat
-
Barcelona, Spanien, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebron - VHIO
-
Kontakt:
- Jordi Perera
- Telefonnummer: 0034 932543454 ext. 1256
- E-mail: jperera@vhio.net
-
Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Kontakt:
- Rocío Garcia Carbonero
- Telefonnummer: 0034 913908003
-
Seville, Spanien, 41013
- Rekruttering
- Hospital Universitario Virgen del Rocio
-
Kontakt:
- Inmaculada Gallego Jimenez
- Telefonnummer: 0034 955018613
- E-mail: inmaculada.gallego.jimenez.sspa@juntadeandalucia.es
-
Valencia, Spanien, 46010
- Rekruttering
- Hospital Clinico Universitario de Valencia
-
Kontakt:
- Lorena SazLluch
- Telefonnummer: 0034 629260816
- E-mail: lsaz@incliva.es
-
Zaragoza, Spanien, 50009
- Rekruttering
- Hospital Universitario Miguel Servet
-
Kontakt:
- Roberto Pazo Cid
- Telefonnummer: 0034 976765500
- E-mail: rpazo@salud.aragon.es
-
-
Navarre
-
Pamplona, Navarre, Spanien, 31008
- Rekruttering
- Clinica Universidad de Navarra
-
Kontakt:
- Estibaliz San Martín González
- Telefonnummer: 2712 0034 948255400
- E-mail: esgonzalez@unav.es
-
-
-
-
-
Busan, Sydkorea, 49201
- Rekruttering
- Dong-A University Hospital
-
Kontakt:
- Ae ri Jang
- Telefonnummer: 82512402576
- E-mail: dongahicrc33@naver.com
-
Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
-
Kontakt:
- Changhoon Yoo
- Telefonnummer: 82230101727
- E-mail: yooc@amc.seoul.kr
-
Seoul, Sydkorea, 03080
- Rekruttering
- Seoul National University Hospital
-
Kontakt:
- Do-Yoon Oh
- Telefonnummer: 82220720701
- E-mail: ohdoyoun@snu.ac.kr
-
Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Kontakt:
- Hyangsuk Jeong
- Telefonnummer: +82 2 3410 0955
- E-mail: hyangsuk.jeong@samsung.com
-
-
-
-
-
Frankfurt, Tyskland, 60488
- Rekruttering
- Krankenhaus Nordwest GmbH
-
Kontakt:
- Thorsten Oliver Götze
- Telefonnummer: +49 69 7601 4420
- E-mail: Info.IKF@khnw.DE
-
Heidelberg, Tyskland, 69120
- Rekruttering
- Universitaetsklinikum Heidelberg
-
Kontakt:
- Christoph Springfeld
- Telefonnummer: +49 6221 56 6857
- E-mail: christoph.springfeld@med.uni-heidelberg.de
-
Ulm, Tyskland, 89081
- Rekruttering
- Universitaetsklinikum Ulm
-
Kontakt:
- Thomas Seufferlein
- Telefonnummer: +49 731 500 44501
- E-mail: thomas.seufferlein@uniklinik-ulm.de
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: daraxonrasib
study drug |
oral tablets |
|
Ingen indgriben: SOC Observation
Patients randomized to the comparator control arm will receive SOC observation. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. december 2025
Primær færdiggørelse (Anslået)
10. maj 2029
Studieafslutning (Anslået)
10. juli 2030
Datoer for studieregistrering
Først indsendt
13. november 2025
Først indsendt, der opfyldte QC-kriterier
18. november 2025
Først opslået (Faktiske)
26. november 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. oktober 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RMC-6236-304
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .