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NCT07522073RecruitingPhase 3

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
588 (estimated)
First submitted
3 Apr 2026
Start date
9 Apr 2026
Primary completion date
15 Sept 2028
Lead sponsor
Incyte Corporation
NCT number
NCT07522073

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 588
  • From 9 Apr 2026 to the primary completion date, 15 Sept 2028
  • 230 sites in 22 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 any KRAS inhibitor
  • Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug

Other

  • Known active CNS metastases
    • Other protocol-defined Inclusion/Exclusion Criteria may apply.

Who the study is looking for

  • Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation
  • No prior systemic treatment in the metastatic setting
  • ECOG Performance status 0-1
  • Adequate organ function

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

Full criteria on ClinicalTrials.gov

Sites (230)

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

SiteCityCountrySite status
Investigative Site AT005
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GrazAustriaNot yet recruiting
Investigative Site AT002
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InnsbruckAustriaRecruiting
Investigative Site AT004
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LinzAustriaRecruiting
Investigative Site AT003
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SalzburgAustriaRecruiting
Investigative Site AU002
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CanberraAustraliaNot yet recruiting
Investigative Site AU010
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ChermsideAustraliaNot yet recruiting
Investigative Site AU011
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Macquarie ParkAustraliaNot yet recruiting
Investigative Site AU004
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MelbourneAustraliaRecruiting
Investigative Site AU001
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MelbourneAustraliaRecruiting
Investigative Site AU008
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PerthAustraliaRecruiting
Investigative Site AU005
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RichmondAustraliaRecruiting
Investigative Site AU009
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TownsvilleAustraliaRecruiting
Investigative Site AU006
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Woodville SouthAustraliaRecruiting
Investigative Site BE008
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AnderlechtBelgiumNot yet recruiting
Investigative Site BE009
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BrusselsBelgiumRecruiting
Investigative Site BE003
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BrusselsBelgiumRecruiting
Investigative Site BE001
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EdegemBelgiumRecruiting
Investigative Site BE005
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GhentBelgiumRecruiting
Investigative Site BE007
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GillyBelgiumRecruiting
Investigative Site BE004
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LeuvenBelgiumRecruiting
Investigative Site BE006
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LiègeBelgiumNot yet recruiting
Investigative Site BE002
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YvoirBelgiumNot yet recruiting
Investigative Site CA007
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HamiltonCanadaNot yet recruiting
Investigative Site CA008
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KingstonCanadaNot yet recruiting
Investigative Site CA006
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MontrealCanadaRecruiting
Investigative Site CA004
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QuébecCanadaRecruiting
Investigative Site CA001
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TorontoCanadaRecruiting
Investigative Site CH005
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BaselSwitzerlandRecruiting
Investigative Site CH003
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BernSwitzerlandNot yet recruiting
Investigative Site CH004
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GenevaSwitzerlandNot yet recruiting
Investigative Site CH002
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LausanneSwitzerlandRecruiting
Investigative Site CH001
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ZurichSwitzerlandRecruiting
Investigative Site DE018
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BerlinGermanyNot yet recruiting
Investigative Site DE020
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BerlinGermanyRecruiting
Investigative Site DE003
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BochumGermanyRecruiting
Investigative Site DE019
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BonnGermanyNot yet recruiting
Investigative Site DE008
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CologneGermanyRecruiting
Investigative Site DE001
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DresdenGermanyNot yet recruiting
Investigative Site DE013
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DüsseldorfGermanyNot yet recruiting
Investigative Site DE004
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EssenGermanyRecruiting
Investigative Site DE005
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FrankfurtGermanyRecruiting
Investigative Site DE016
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Freiburg im BreisgauGermanyRecruiting
Investigative Site DE017
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GöttingenGermanyNot yet recruiting
Investigative Site DE002
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HalleGermanyNot yet recruiting
Investigative Site DE006
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HamburgGermanyRecruiting
Investigative Site DE007
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HamburgGermanyRecruiting
Investigative Site DE009
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LeipzigGermanyNot yet recruiting
Investigative Site DE014
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MünchenGermanyRecruiting
Investigative Site DE015
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MunichGermanyNot yet recruiting
Investigative Site DE010
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NurembergGermanyRecruiting
Investigative Site DE011
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UlmGermanyRecruiting
Investigative Site DK006
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AalborgDenmarkNot yet recruiting
Investigative Site DK005
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Århus NDenmarkRecruiting
Investigative Site DK001
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HerlevDenmarkNot yet recruiting
Investigative Site DK003
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KøgeDenmarkNot yet recruiting
Investigative Site DK004
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Odense CDenmarkNot yet recruiting
Investigative Site DK002
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VejleDenmarkNot yet recruiting
Investigative Site ES011
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BadalonaSpainNot yet recruiting
Investigative Site ES002
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BarcelonaSpainRecruiting
Investigative Site ES003
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BarcelonaSpainNot yet recruiting
Investigative Site ES014
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Las Palmas de Gran CanariaSpainRecruiting
Investigative Site ES008
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MadridSpainRecruiting
Investigative Site ES012
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MadridSpainNot yet recruiting
Investigative Site ES013
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MadridSpainRecruiting
Investigative Site ES006
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MadridSpainNot yet recruiting
Investigative Site ES007
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MadridSpainRecruiting
Investigative Site ES016
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MadridSpainRecruiting
Investigative Site ES005
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Palma de MallorcaSpainNot yet recruiting
Investigative Site ES009
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SantanderSpainRecruiting
Investigative Site ES010
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SevilleSpainNot yet recruiting
Investigative Site ES001
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ValenciaSpainRecruiting
Investigative Site ES017
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ValenciaSpainNot yet recruiting
Investigative Site ES015
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ValenciaSpainNot yet recruiting
Investigative Site ES004
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ZaragozaSpainRecruiting
Investigative Site FI001
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HUSFinlandRecruiting
Investigative Site FI003
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TampereFinlandRecruiting
Investigative Site FI002
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TurkuFinlandNot yet recruiting
Investigative Site FR013
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BrestFranceNot yet recruiting
Investigative Site FR014
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DijonFranceNot yet recruiting
Investigative Site FR002
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LilleFranceNot yet recruiting
Investigative Site FR016
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LyonFranceNot yet recruiting
Investigative Site FR011
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LyonFranceNot yet recruiting
Investigative Site FR006
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MarseilleFranceNot yet recruiting
Investigative Site FR015
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MontpellierFranceNot yet recruiting
Investigative Site FR003
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ParisFranceNot yet recruiting
Investigative Site FR009
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ParisFranceNot yet recruiting
Investigative Site FR004
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PessacFranceNot yet recruiting
Investigative Site FR008
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PoitiersFranceNot yet recruiting
Investigative Site FR010
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ReimsFranceRecruiting
Investigative Site FR005
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RennesFranceRecruiting
Investigative Site FR007
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ToulouseFranceNot yet recruiting
Investigative Site FR012
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ToursFranceNot yet recruiting
Investigative Site FR001
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VillejuifFranceNot yet recruiting
Investigative Site GR008
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DundeeUnited KingdomRecruiting
Investigative Site GB011
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GuildfordUnited KingdomNot yet recruiting
Investigative Site GB002
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HeadingtonUnited KingdomNot yet recruiting
Investigative Site GB001
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LeedsUnited KingdomNot yet recruiting
Investigative Site GB009
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LondonUnited KingdomRecruiting
Investigative Site GB004
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LondonUnited KingdomNot yet recruiting
Investigative Site GB003
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ManchesterUnited KingdomNot yet recruiting
Investigative Site GB010
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NorthwoodUnited KingdomNot yet recruiting
Investigative Site GB005
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NorwichUnited KingdomNot yet recruiting
Investigative Site GE004
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BatumiGeorgiaNot yet recruiting
Investigative Site GE002
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MarneuliGeorgiaNot yet recruiting
Investigative Site GE003
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TbilisiGeorgiaNot yet recruiting
Investigative Site GE001
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TbilisiGeorgiaNot yet recruiting
Investigative Site GE005
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TbilisiGeorgiaNot yet recruiting
Investigative Site GE006
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TbilisiGeorgiaNot yet recruiting
Investigative Site IT002
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BolognaItalyNot yet recruiting
Investigative Site IT010
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BresciaItalyRecruiting
Investigative Site IT009
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CandioloItalyRecruiting
Investigative Site IT012
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FoggiaItalyNot yet recruiting
Investigative Site IT006
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MilanItalyRecruiting
Investigative Site IT008
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MilanItalyNot yet recruiting
Investigative Site IT011
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NaplesItalyNot yet recruiting
Investigative Site IT003
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PisaItalyNot yet recruiting
Investigative Site IT004
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RomaItalyRecruiting
Investigative Site IT005
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RomeItalyNot yet recruiting
Investigative Site IT001
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RozzanoItalyRecruiting
Investigative Site IT007
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VeronaItalyRecruiting
Investigative Site JP015
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Akashi, HYGOJapanActive, not recruiting
Investigative Site JP012
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Fukuoka FukuokaJapanNot yet recruiting
Investigative Site JP010
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Kahoku-gunJapanRecruiting
Investigative Site JP014
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Kitaadachi-gunJapanNot yet recruiting
Investigative Site JP003
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KōtokuJapanRecruiting
Investigative Site JP007
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Mitaka-shiJapanRecruiting
Investigative Site JP004
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OsakaJapanRecruiting
Investigative Site JP011
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Sapporo HokkaidoJapanNot yet recruiting
Investigative Site JP009
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Shinjuku-kuJapanRecruiting
Investigative Site JP013
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Suita, OsakaJapanNot yet recruiting
Investigative Site JP006
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ToyamaJapanRecruiting
Investigative Site JP008
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WakayamaJapanRecruiting
Investigative Site JP001
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YokohamaJapanRecruiting
Investigative Site KR004
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Goyang-siSouth KoreaRecruiting
Investigative Site KR007
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Seongnam-siSouth KoreaRecruiting
Investigative Site KR005
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Seongnam-siSouth KoreaRecruiting
Investigative Site KR002
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SeoulSouth KoreaRecruiting
Investigative Site KR008
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SeoulSouth KoreaNot yet recruiting
Investigative Site KR006
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SeoulSouth KoreaRecruiting
Investigative Site KR003
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SeoulSouth KoreaRecruiting
Investigative Site KR001
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SeoulSouth KoreaRecruiting
Investigative Site NL001
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AmsterdamNetherlandsRecruiting
Investigative Site NL007
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EindhovenNetherlandsRecruiting
Investigative Site NL005
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GroningenNetherlandsRecruiting
Investigative Site NL003
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MaastrichtNetherlandsRecruiting
Investigative Site NL006
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UtrechtNetherlandsRecruiting
Investigative Site NO002
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BergenNorwayRecruiting
Investigative Site NO001
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OsloNorwayRecruiting
Investigative Site NO005
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StavangerNorwayNot yet recruiting
Investigative Site NO003
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TrondheimNorwayNot yet recruiting
Investigative Site NZ001
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AucklandNew ZealandNot yet recruiting
Investigative Site PL008
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GdanskPolandNot yet recruiting
Investigative Site PL003
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KrakowPolandNot yet recruiting
Investigative Site PL001
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WarsawPolandRecruiting
Investigative Site PL007
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WarsawPolandRecruiting
Investigative Site PL002
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WarsawPolandNot yet recruiting
Investigative Site PL004
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WroclawPolandNot yet recruiting
Investigative Site PR001
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DoradoPuerto RicoRecruiting
Investigative Site SE003
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LinköpingSwedenNot yet recruiting
Investigative Site SE001
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LundSwedenRecruiting
Investigative Site SE002
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StockholmSwedenRecruiting
Investigative Site US016
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AnchorageUnited StatesRecruiting
Investigative Site US006
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Ann ArborUnited StatesNot yet recruiting
Investigative Site US023
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AtlantaUnited StatesRecruiting
Investigative Site US058
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BirminghamUnited StatesNot yet recruiting
Investigative Site US022
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BostonUnited StatesRecruiting
Investigative Site US026
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ChandlerUnited StatesRecruiting
Investigative Site US035
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Chapel HillUnited StatesRecruiting
Investigative Site US082
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CharlestonUnited StatesNot yet recruiting
Investigative Site US079
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ChicagoUnited StatesNot yet recruiting
Investigative Site US050
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ClevelandUnited StatesRecruiting
Investigative Site US020
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ClevelandUnited StatesRecruiting
Investigative Site US033
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ColumbusUnited StatesNot yet recruiting
Investigative Site US067
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DallasUnited StatesRecruiting
Investigative Site US062
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DenisonUnited StatesRecruiting
Investigative Site US071
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DenverUnited StatesRecruiting
Investigative Site US010
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DetroitUnited StatesRecruiting
Investigative Site US051
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DuarteUnited StatesRecruiting
Investigative Site US030
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EvanstonUnited StatesRecruiting
Investigative Site US065
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FairfaxUnited StatesRecruiting
Investigative Site US057
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FairfaxUnited StatesNot yet recruiting
Investigative Site US072
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Fort MyersUnited StatesRecruiting
Investigative Site US085
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FullertonUnited StatesNot yet recruiting
Investigative Site US078
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Grand RapidsUnited StatesRecruiting
Investigative Site US077
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HackensackUnited StatesRecruiting
Investigative Site US047
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HattiesburgUnited StatesNot yet recruiting
Investigative Site US011
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HoustonUnited StatesRecruiting
Investigative Site US021
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IndianapolisUnited StatesNot yet recruiting
Investigative Site US083
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JacksonvilleUnited StatesNot yet recruiting
Investigative Site US054
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La JollaUnited StatesNot yet recruiting
Investigative Site US059
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Lake SuccessUnited StatesRecruiting
Investigative Site US086
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Long BeachUnited StatesNot yet recruiting
Investigative Site US036
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Los AngelesUnited StatesRecruiting
Investigative Site US027
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Los AngelesUnited StatesRecruiting
Investigative Site US048
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Los AngelesUnited StatesRecruiting
Investigative Site US044
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MadisonUnited StatesRecruiting
Investigative Site US066
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Maple GroveUnited StatesRecruiting
Investigative Site US075
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MiamiUnited StatesRecruiting
Investigative Site US017
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MorristownUnited StatesRecruiting
Investigative Site US005
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NapervilleUnited StatesRecruiting
Investigative Site US070
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NashvilleUnited StatesRecruiting
Investigative Site US060
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NashvilleUnited StatesRecruiting
Investigative Site US039
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NashvilleUnited StatesRecruiting
Investigative Site US007
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New OrleansUnited StatesRecruiting
Investigative Site US031
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New YorkUnited StatesRecruiting
Investigative Site US003
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New YorkUnited StatesRecruiting
Investigative Site US041
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New YorkUnited StatesRecruiting
Investigative Site US081
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OlympiaUnited StatesRecruiting
Investigative Site US049
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OrangeUnited StatesRecruiting
Investigative Site US008
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PhiladelphiaUnited StatesRecruiting
Investigative Site US043
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PhiladelphiaUnited StatesRecruiting
Investigative Site US056
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PittsburghUnited StatesRecruiting
Investigative Site US042
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PortlandUnited StatesNot yet recruiting
Investigative Site US084
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RenoUnited StatesNot yet recruiting
Investigative Site US064
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SalemUnited StatesRecruiting
Investigative Site US053
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Salt Lake CityUnited StatesRecruiting
Investigative Site US063
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San AntonioUnited StatesRecruiting
Investigative Site US080
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San AntonioUnited StatesNot yet recruiting
Investigative Site US034
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San FranciscoUnited StatesRecruiting
Investigative Site US001
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Santa MonicaUnited StatesRecruiting
Investigative Site US032
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SeattleUnited StatesRecruiting
Investigative Site US055
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Sioux FallsUnited StatesRecruiting
Investigative Site US009
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SpringfieldUnited StatesRecruiting
Investigative Site US074
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St. PetersburgUnited StatesRecruiting
Investigative Site US029
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The BronxUnited StatesRecruiting
Investigative Site US045
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TucsonUnited StatesNot yet recruiting
Investigative Site US046
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Washington D.C.United StatesNot yet recruiting
Investigative Site US013
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Washington D.C.United StatesNot yet recruiting
Investigative Site US073
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West Palm BeachUnited StatesRecruiting
Investigative Site US012
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YpsilantiUnited StatesNot yet recruiting

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