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NCT07491445RecruitingPhase 3

Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
900 (estimated)
First submitted
10 Mar 2026
Start date
9 Mar 2026
Primary completion date
30 Jun 2028
Lead sponsor
Revolution Medicines, Inc.
NCT number
NCT07491445
EU CT number
2025-525088-34-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 900
  • From 9 Mar 2026 to the primary completion date, 30 Jun 2028
  • 137 sites in 21 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.
  • Major surgery within 28 days prior to randomization.

Other illness

  • Active or known history of untreated central nervous system metastatic disease.
  • Any conditions that may affect the ability to take or absorb study drug.

Other

  • Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Who the study is looking for

  • At least 18 years old and has provided informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically or cytologically confirmed pancreatic adenocarcinoma.
  • Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
  • Documented RAS mutation status, either mutant or wild-type.
  • Measurable disease per RECIST v1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • Able to take oral medications.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (137)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaRecruiting
Ordensklinikum Linz GmbH
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LinzAustriaRecruiting
Oberoesterreichische Gesundheitsholding GmbH
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SteyrAustriaRecruiting
Krankenhaus Der Barmherzigen Brueder Wien
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ViennaAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Epworth Healthcare
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East MelbourneAustraliaRecruiting
Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
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HeidelbergAustraliaRecruiting
Royal Brisbane and Women's Hospital
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HerstonAustraliaRecruiting
St George Hospital
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KogarahAustraliaRecruiting
Prince of Wales Hospital
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RandwickAustraliaRecruiting
Calvary Mater Newcastle
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WaratahAustraliaRecruiting
Institut Jules Bordet
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AnderlechtBelgiumRecruiting
Imelda
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BonheidenBelgiumRecruiting
Grand Hopital de Charleroi
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CharleroiBelgiumRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
CEPON - Centro de Pesquisa Oncologicas de Santa Catarina
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FlorianópolisBrazilRecruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
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São PauloBrazilRecruiting
McGill University - Dept. Oncology Clinical Research Program
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MontrealCanadaRecruiting
Princess Margaret Cancer Centre
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TorontoCanadaRecruiting
Sunnybrook Research Institute
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TorontoCanadaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Sana Kliniken Berlin-Brandenburg GmbH
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BerlinGermanyRecruiting
Katholisches Klinikum Bochum gGmbH
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BochumGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Technische Universitaet Dresden
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DresdenGermanyRecruiting
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Klinikum München-Bogenhausen
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MünchenGermanyRecruiting
Klinikum rechts der Isar der Technischen Universität München
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MünchenGermanyRecruiting
Klinikum der Ludwigs-Maximilians-Universität München, Campus Großhadern
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MünchenGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyRecruiting
Region Midtjylland
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Aarhus NDenmarkRecruiting
Region Hovedstaden
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HerlevDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainRecruiting
Institut Bergonie
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BordeauxFranceWithdrawn
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceWithdrawn
Centr Georges Francois Leclerc
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DijonFranceWithdrawn
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceWithdrawn
Centre Leon Berard
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LyonFranceWithdrawn
CARIO Centre Armoricain de Radiotherapie d'Imagerie medicale et d'Oncologie
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PlerinFranceWithdrawn
Centre De Lutte Contre Le Cancer Eugene Marquis
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Rennes CedexFranceWithdrawn
Institut Gustave Roussy
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VillejuifFranceWithdrawn
Hopital Paul Brousse
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Villejuif CedexFranceWithdrawn
Queen Elizabeth Hospital Birmingham
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BirminghamUnited KingdomRecruiting
NHS Cambridge of Addenbrooke Hospital
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CambridgeUnited KingdomRecruiting
The Clatterbridge Cancer Centre
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LiverpoolUnited KingdomRecruiting
Sarah Cannon Research Institute UK
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LondonUnited KingdomRecruiting
University College London Hospital
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LondonUnited KingdomRecruiting
Barts Hospital
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LondonUnited KingdomRecruiting
Guy's Hospital
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LondonUnited KingdomRecruiting
Royal Marsden Hospital - London
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LondonUnited KingdomRecruiting
Royal Free Hospital
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust
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ManchesterUnited KingdomRecruiting
Torbay Hospital
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TorquayUnited KingdomRecruiting
The Chinese University of Hong Kong
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Hong KongHong Kong SAR ChinaRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
Istituto Oncologico Veneto
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PadovaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Pia Fondazione Di Culto E Religione Card G Panico
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TricaseItalyRecruiting
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyRecruiting
Chiba Cancer Center
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ChibaJapanRecruiting
NHO Kyushu Cancer Center
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FukuokaJapanRecruiting
Kyushu University Hospital
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FukuokaJapanRecruiting
Kanagawa Cancer Canter
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KanagawaJapanRecruiting
National Cancer Center East
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KashiwaJapanRecruiting
Cancer Institute Hospital - Japan Foundation for Cancer Research
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Koto-KuJapanRecruiting
Osaka International Cancer Institute
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OsakaJapanRecruiting
National Cancer Center - Tokyo
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TokyoJapanRecruiting
Wakayama Medical University Hospital
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WakayamaJapanRecruiting
Yamaguchi University Hospital
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YamaguchiJapanRecruiting
Dong-A University Hospital
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BusanSouth KoreaRecruiting
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaRecruiting
Asan Medical Center - PPDS
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Stichting OLVG
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AmsterdamNetherlandsRecruiting
St. Antonius Ziekenhuis
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NieuwegeinNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Oslo Universitetssykehus HF
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OsloNorwayRecruiting
St. Olavs hospital HF
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TrondheimNorwayRecruiting
Pratia Onkologia Katowice
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KatowicePolandRecruiting
Pratia MCM Krakow
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KrakowPolandRecruiting
MTZ Clinical Research powered by Pratia
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WarsawPolandRecruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenRecruiting
Karolinska University Hospital
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HuddingeSwedenRecruiting
Region Vaesterbotten
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UmeaSwedenRecruiting
Region Kronoberg
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VaxjoSwedenRecruiting
Curie Oncology Pte Ltd
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SingaporeSingaporeRecruiting
National Cancer Centre Singapore
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SingaporeSingaporeRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
China Medical University Hospital
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TaichungTaiwanRecruiting
National Cheng Kung University Hospital
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TainanTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Taipei Veterans General Hospital
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TaipeiTaiwanRecruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
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BaltimoreUnited StatesActive, not recruiting
Dana-Farber Cancer Institute
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BostonUnited StatesActive, not recruiting
University of Cincinnati Cancer Center
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CincinnatiUnited StatesActive, not recruiting
SCRI - Texas Oncology Dallas
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DallasUnited StatesActive, not recruiting
Henry Ford Health System
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DetroitUnited StatesActive, not recruiting
Duke University Medical Center
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DurhamUnited StatesActive, not recruiting
Virginia Cancer Specialists
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FairfaxUnited StatesActive, not recruiting
Comprehensive Cancer Centers of Nevada
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HendersonUnited StatesActive, not recruiting
MD Anderson Cancer Center
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HoustonUnited StatesActive, not recruiting
Mayo Clinic Cancer Center- Florida
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JacksonvilleUnited StatesActive, not recruiting
University of California Los Angeles Health - Hematology/Oncology
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Los AngelesUnited StatesActive, not recruiting
Taylor Cancer Research Center
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MaumeeUnited StatesActive, not recruiting
SCRI Oncology Partners
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NashvilleUnited StatesActive, not recruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesActive, not recruiting
Mayo Clinic - Scottsdale
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PhoenixUnited StatesActive, not recruiting
Mayo Clinic Cancer Center - Rochester
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RochesterUnited StatesActive, not recruiting
Huntsman Cancer Institute
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Salt Lake CityUnited StatesActive, not recruiting
University of California San Francisco
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San FranciscoUnited StatesActive, not recruiting
Honor Health Research Institute
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ScottsdaleUnited StatesActive, not recruiting
Virginia Mason Medical Center
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SeattleUnited StatesActive, not recruiting
H Lee Moffitt Cancer Center and Research Institute
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TampaUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.