En undersøgelse til evaluering af kemoterapi med eller uden INCB161734 hos tidligere ubehandlede patienter med KRAS G12D-muteret metastatisk pankreasductal adenokarcinom (DAWN-303)
28. oktober 2026 opdateret af: Incyte Corporation
En randomiseret, dobbeltblind fase 3-undersøgelse af kemoterapi med eller uden INCB161734 i tidligere ubehandlet, KRAS G12D-muteret metastatisk pankreatisk duktaladenokarcinom (DAWN-303)
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).
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
588
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Incyte Corporation Call Center (US)
- Telefonnummer: 1.855.463.3463
- E-mail: medinfo@incyte.com
Undersøgelse Kontakt Backup
- Navn: Incyte Corporation Call Center (ex-US)
- Telefonnummer: +800 00027423
- E-mail: eumedinfo@incyte.com
Studiesteder
-
-
-
Canberra, Australien, 02605
- Ikke rekrutterer endnu
- Investigative Site AU002
-
Perth, Australien, 06009
- Rekruttering
- Investigative Site AU008
-
-
New South Wales
-
Macquarie Park, New South Wales, Australien, 02109
- Ikke rekrutterer endnu
- Investigative Site AU011
-
-
Queensland
-
Chermside, Queensland, Australien, 04032
- Ikke rekrutterer endnu
- Investigative Site AU010
-
Townsville, Queensland, Australien, 04814
- Rekruttering
- Investigative Site AU009
-
-
South Australia
-
Woodville South, South Australia, Australien, 05011
- Rekruttering
- Investigative Site AU006
-
-
Victoria
-
Melbourne, Victoria, Australien, 03000
- Rekruttering
- Investigative Site AU004
-
Melbourne, Victoria, Australien, 03004
- Rekruttering
- Investigative Site AU001
-
Richmond, Victoria, Australien, 03121
- Rekruttering
- Investigative Site AU005
-
-
-
-
-
Anderlecht, Belgien, 01070
- Ikke rekrutterer endnu
- Investigative Site BE008
-
Brussels, Belgien, 01090
- Rekruttering
- Investigative Site BE003
-
Brussels, Belgien, 01200
- Rekruttering
- Investigative Site BE009
-
Edegem, Belgien, 02650
- Rekruttering
- Investigative Site BE001
-
Ghent, Belgien, 09000
- Rekruttering
- Investigative Site BE005
-
Gilly, Belgien, 06060
- Rekruttering
- Investigative Site BE007
-
Leuven, Belgien, 03000
- Rekruttering
- Investigative Site BE004
-
Liège, Belgien, 04000
- Ikke rekrutterer endnu
- Investigative Site BE006
-
Yvoir, Belgien, 05530
- Ikke rekrutterer endnu
- Investigative Site BE002
-
-
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V5C2
- Ikke rekrutterer endnu
- Investigative Site CA007
-
Kingston, Ontario, Canada, K7L 5P9
- Ikke rekrutterer endnu
- Investigative Site CA008
-
Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Investigative Site CA001
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3J1
- Rekruttering
- Investigative Site CA006
-
Québec, Quebec, Canada, G1J 1Z4
- Rekruttering
- Investigative Site CA004
-
-
-
-
-
Aalborg, Danmark, 09000
- Ikke rekrutterer endnu
- Investigative Site DK006
-
Herlev, Danmark, 02730
- Ikke rekrutterer endnu
- Investigative Site DK001
-
Køge, Danmark, 04600
- Ikke rekrutterer endnu
- Investigative Site DK003
-
Odense C, Danmark, 05000
- Ikke rekrutterer endnu
- Investigative Site DK004
-
Vejle, Danmark, 07100
- Ikke rekrutterer endnu
- Investigative Site DK002
-
Århus N, Danmark, 08200
- Rekruttering
- Investigative Site DK005
-
-
-
-
-
Dundee, Det Forenede Kongerige, DD1 9SY
- Rekruttering
- Investigative Site GR008
-
Guildford, Det Forenede Kongerige, GU2 7XX
- Ikke rekrutterer endnu
- Investigative Site GB011
-
Headington, Det Forenede Kongerige, OX3 7LE
- Ikke rekrutterer endnu
- Investigative Site GB002
-
Leeds, Det Forenede Kongerige, LS9 7TF
- Ikke rekrutterer endnu
- Investigative Site GB001
-
London, Det Forenede Kongerige, NW3 2QG
- Ikke rekrutterer endnu
- Investigative Site GB004
-
London, Det Forenede Kongerige, EC1A 7BE
- Rekruttering
- Investigative Site GB009
-
Manchester, Det Forenede Kongerige, M20 4BX
- Ikke rekrutterer endnu
- Investigative Site GB003
-
Northwood, Det Forenede Kongerige, HA6 2RN
- Ikke rekrutterer endnu
- Investigative Site GB010
-
Norwich, Det Forenede Kongerige, NR4 7UY
- Ikke rekrutterer endnu
- Investigative Site GB005
-
-
-
-
-
HUS, Finland, 00290
- Rekruttering
- Investigative Site FI001
-
Tampere, Finland, 33521
- Rekruttering
- Investigative Site FI003
-
Turku, Finland, 20521
- Ikke rekrutterer endnu
- Investigative Site FI002
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35233
- Ikke rekrutterer endnu
- Investigative Site US058
-
-
Alaska
-
Anchorage, Alaska, Forenede Stater, 99508
- Rekruttering
- Investigative Site US016
-
-
Arizona
-
Chandler, Arizona, Forenede Stater, 85224
- Rekruttering
- Investigative Site US026
-
Tucson, Arizona, Forenede Stater, 85719
- Ikke rekrutterer endnu
- Investigative Site US045
-
-
California
-
Duarte, California, Forenede Stater, 91010
- Rekruttering
- Investigative Site US051
-
Fullerton, California, Forenede Stater, 92835
- Ikke rekrutterer endnu
- Investigative Site US085
-
La Jolla, California, Forenede Stater, 92093
- Ikke rekrutterer endnu
- Investigative Site US054
-
Long Beach, California, Forenede Stater, 90806-1650
- Ikke rekrutterer endnu
- Investigative Site US086
-
Los Angeles, California, Forenede Stater, 90089
- Rekruttering
- Investigative Site US036
-
Los Angeles, California, Forenede Stater, 90027
- Rekruttering
- Investigative Site US027
-
Los Angeles, California, Forenede Stater, 91204-3640
- Rekruttering
- Investigative Site US048
-
Orange, California, Forenede Stater, 92868
- Rekruttering
- Investigative Site US049
-
San Francisco, California, Forenede Stater, 94143
- Rekruttering
- Investigative Site US034
-
Santa Monica, California, Forenede Stater, 90404
- Rekruttering
- Investigative Site US001
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80218
- Rekruttering
- Investigative Site US071
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20007
- Ikke rekrutterer endnu
- Investigative Site US013
-
Washington D.C., District of Columbia, Forenede Stater, 20016
- Ikke rekrutterer endnu
- Investigative Site US046
-
-
Florida
-
Fort Myers, Florida, Forenede Stater, 33901
- Rekruttering
- Investigative Site US072
-
Jacksonville, Florida, Forenede Stater, 32207
- Ikke rekrutterer endnu
- Investigative Site US083
-
Miami, Florida, Forenede Stater, 33136
- Rekruttering
- Investigative Site US075
-
St. Petersburg, Florida, Forenede Stater, 33701-4553
- Rekruttering
- Investigative Site US074
-
West Palm Beach, Florida, Forenede Stater, 33401
- Rekruttering
- Investigative Site US073
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Investigative Site US023
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60637
- Ikke rekrutterer endnu
- Investigative Site US079
-
Evanston, Illinois, Forenede Stater, 60201
- Rekruttering
- Investigative Site US030
-
Naperville, Illinois, Forenede Stater, 60540
- Rekruttering
- Investigative Site US005
-
Springfield, Illinois, Forenede Stater, 62702
- Rekruttering
- Investigative Site US009
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46250
- Ikke rekrutterer endnu
- Investigative Site US021
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70121
- Rekruttering
- Investigative Site US007
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Investigative Site US022
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109-9001
- Ikke rekrutterer endnu
- Investigative Site US006
-
Detroit, Michigan, Forenede Stater, 48201
- Rekruttering
- Investigative Site US010
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Rekruttering
- Investigative Site US078
-
Ypsilanti, Michigan, Forenede Stater, 48197
- Ikke rekrutterer endnu
- Investigative Site US012
-
-
Minnesota
-
Maple Grove, Minnesota, Forenede Stater, 55369
- Rekruttering
- Investigative Site US066
-
-
Mississippi
-
Hattiesburg, Mississippi, Forenede Stater, 39401
- Ikke rekrutterer endnu
- Investigative Site US047
-
-
Nevada
-
Reno, Nevada, Forenede Stater, 89502
- Ikke rekrutterer endnu
- Investigative Site US084
-
-
New Jersey
-
Hackensack, New Jersey, Forenede Stater, 07601
- Rekruttering
- Investigative Site US077
-
Morristown, New Jersey, Forenede Stater, 07960
- Rekruttering
- Investigative Site US017
-
-
New York
-
Lake Success, New York, Forenede Stater, 11042
- Rekruttering
- Investigative Site US059
-
New York, New York, Forenede Stater, 10065
- Rekruttering
- Investigative Site US003
-
New York, New York, Forenede Stater, 10016
- Rekruttering
- Investigative Site US031
-
New York, New York, Forenede Stater, 10128
- Rekruttering
- Investigative Site US041
-
The Bronx, New York, Forenede Stater, 10461
- Rekruttering
- Investigative Site US029
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater, 27514
- Rekruttering
- Investigative Site US035
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Investigative Site US020
-
Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- Investigative Site US050
-
Columbus, Ohio, Forenede Stater, 43210
- Ikke rekrutterer endnu
- Investigative Site US033
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97239
- Ikke rekrutterer endnu
- Investigative Site US042
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- Investigative Site US008
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Rekruttering
- Investigative Site US043
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Rekruttering
- Investigative Site US056
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Ikke rekrutterer endnu
- Investigative Site US082
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57105-2140
- Rekruttering
- Investigative Site US055
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Investigative Site US060
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Investigative Site US039
-
Nashville, Tennessee, Forenede Stater, 37232-6309
- Rekruttering
- Investigative Site US070
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75246
- Rekruttering
- Investigative Site US067
-
Denison, Texas, Forenede Stater, 75020
- Rekruttering
- Investigative Site US062
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Investigative Site US011
-
San Antonio, Texas, Forenede Stater, 78240
- Rekruttering
- Investigative Site US063
-
San Antonio, Texas, Forenede Stater, 78229
- Ikke rekrutterer endnu
- Investigative Site US080
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Rekruttering
- Investigative Site US053
-
-
Virginia
-
Fairfax, Virginia, Forenede Stater, 22031
- Ikke rekrutterer endnu
- Investigative Site US057
-
Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Investigative Site US065
-
Salem, Virginia, Forenede Stater, 24153
- Rekruttering
- Investigative Site US064
-
-
Washington
-
Olympia, Washington, Forenede Stater, 98506
- Rekruttering
- Investigative Site US081
-
Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Investigative Site US032
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53792
- Rekruttering
- Investigative Site US044
-
-
-
-
-
Brest, Frankrig, 29200
- Ikke rekrutterer endnu
- Investigative Site FR013
-
Dijon, Frankrig, 21000
- Ikke rekrutterer endnu
- Investigative Site FR014
-
Lille, Frankrig, 59037
- Ikke rekrutterer endnu
- Investigative Site FR002
-
Lyon, Frankrig, 69008
- Ikke rekrutterer endnu
- Investigative Site FR011
-
Lyon, Frankrig, 69373
- Ikke rekrutterer endnu
- Investigative Site FR016
-
Marseille, Frankrig, 13385
- Ikke rekrutterer endnu
- Investigative Site FR006
-
Montpellier, Frankrig, 34298
- Ikke rekrutterer endnu
- Investigative Site FR015
-
Paris, Frankrig, 75013
- Ikke rekrutterer endnu
- Investigative Site FR003
-
Paris, Frankrig, 75015
- Ikke rekrutterer endnu
- Investigative Site FR009
-
Pessac, Frankrig, 33604
- Ikke rekrutterer endnu
- Investigative Site FR004
-
Poitiers, Frankrig, 86021
- Ikke rekrutterer endnu
- Investigative Site FR008
-
Reims, Frankrig, 51100
- Rekruttering
- Investigative Site FR010
-
Rennes, Frankrig, 35042
- Rekruttering
- Investigative Site FR005
-
Toulouse, Frankrig, 31059
- Ikke rekrutterer endnu
- Investigative Site FR007
-
Tours, Frankrig, 37000
- Ikke rekrutterer endnu
- Investigative Site FR012
-
Villejuif, Frankrig, 94805
- Ikke rekrutterer endnu
- Investigative Site FR001
-
-
-
-
-
Batumi, Georgien, 06004
- Ikke rekrutterer endnu
- Investigative Site GE004
-
Marneuli, Georgien, 03000
- Ikke rekrutterer endnu
- Investigative Site GE002
-
Tbilisi, Georgien, 00112
- Ikke rekrutterer endnu
- Investigative Site GE005
-
Tbilisi, Georgien, 00159
- Ikke rekrutterer endnu
- Investigative Site GE006
-
Tbilisi, Georgien, 00186
- Ikke rekrutterer endnu
- Investigative Site GE001
-
Tbilisi, Georgien, 00186
- Ikke rekrutterer endnu
- Investigative Site GE003
-
-
-
-
-
Amsterdam, Holland, 1081 HV
- Rekruttering
- Investigative Site NL001
-
Eindhoven, Holland, 5623 EJ
- Rekruttering
- Investigative Site NL007
-
Groningen, Holland, 9700 RB
- Rekruttering
- Investigative Site NL005
-
Maastricht, Holland, 6229 HX
- Rekruttering
- Investigative Site NL003
-
Utrecht, Holland, 3543 AZ
- Rekruttering
- Investigative Site NL006
-
-
-
-
-
Bologna, Italien, 40138
- Ikke rekrutterer endnu
- Investigative Site IT002
-
Brescia, Italien, 25124
- Rekruttering
- Investigative Site IT010
-
Candiolo, Italien, 10060
- Rekruttering
- Investigative Site IT009
-
Foggia, Italien, 71122
- Ikke rekrutterer endnu
- Investigative Site IT012
-
Milan, Italien, 20133
- Ikke rekrutterer endnu
- Investigative Site IT008
-
Milan, Italien, 20132
- Rekruttering
- Investigative Site IT006
-
Naples, Italien, 80131
- Ikke rekrutterer endnu
- Investigative Site IT011
-
Pisa, Italien, 56126
- Ikke rekrutterer endnu
- Investigative Site IT003
-
Roma, Italien, 00152
- Rekruttering
- Investigative Site IT004
-
Rome, Italien, 00138
- Ikke rekrutterer endnu
- Investigative Site IT005
-
Rozzano, Italien, 20089
- Rekruttering
- Investigative Site IT001
-
Verona, Italien, 37134
- Rekruttering
- Investigative Site IT007
-
-
-
-
-
Akashi, HYGO, Japan, 673-0021
- Aktiv, ikke rekrutterende
- Investigative Site JP015
-
Fukuoka Fukuoka, Japan, 812-0054
- Ikke rekrutterer endnu
- Investigative Site JP012
-
Kahoku-gun, Japan, 920-0293
- Rekruttering
- Investigative Site JP010
-
Kitaadachi-gun, Japan, 362-0806
- Ikke rekrutterer endnu
- Investigative Site JP014
-
Kōtoku, Japan, 135-8550
- Rekruttering
- Investigative Site JP003
-
Mitaka-shi, Japan, 181-8611
- Rekruttering
- Investigative Site JP007
-
Osaka, Japan, 541-8567
- Rekruttering
- Investigative Site JP004
-
Sapporo Hokkaido, Japan, 060-0814
- Ikke rekrutterer endnu
- Investigative Site JP011
-
Shinjuku-ku, Japan, 160-0023
- Rekruttering
- Investigative Site JP009
-
Suita, Osaka, Japan, 565-0871
- Ikke rekrutterer endnu
- Investigative Site JP013
-
Toyama, Japan, 930-0194
- Rekruttering
- Investigative Site JP006
-
Wakayama, Japan, 641-8510
- Rekruttering
- Investigative Site JP008
-
Yokohama, Japan, 241-8515
- Rekruttering
- Investigative Site JP001
-
-
-
-
-
Auckland, New Zealand, 01023
- Ikke rekrutterer endnu
- Investigative Site NZ001
-
-
-
-
-
Bergen, Norge, 05021
- Rekruttering
- Investigative Site NO002
-
Oslo, Norge, 00379
- Rekruttering
- Investigative Site NO001
-
Stavanger, Norge, 04011
- Ikke rekrutterer endnu
- Investigative Site NO005
-
Trondheim, Norge, 07030
- Ikke rekrutterer endnu
- Investigative Site NO003
-
-
-
-
-
Gdansk, Polen, 80-214
- Ikke rekrutterer endnu
- Investigative Site PL008
-
Krakow, Polen, 31-501
- Ikke rekrutterer endnu
- Investigative Site PL003
-
Warsaw, Polen, 02-507
- Ikke rekrutterer endnu
- Investigative Site PL002
-
Warsaw, Polen, 01-748
- Rekruttering
- Investigative Site PL007
-
Warsaw, Polen, 02-034
- Rekruttering
- Investigative Site PL001
-
Wroclaw, Polen, 53-439
- Ikke rekrutterer endnu
- Investigative Site PL004
-
-
-
-
-
Dorado, Puerto Rico, 00646
- Rekruttering
- Investigative Site PR001
-
-
-
-
-
Basel, Schweiz, 04058
- Rekruttering
- Investigative Site CH005
-
Bern, Schweiz, 03010
- Ikke rekrutterer endnu
- Investigative Site CH003
-
Geneva, Schweiz, 01205
- Ikke rekrutterer endnu
- Investigative Site CH004
-
Lausanne, Schweiz, 01011
- Rekruttering
- Investigative Site CH002
-
Zurich, Schweiz, 08091
- Rekruttering
- Investigative Site CH001
-
-
-
-
-
Badalona, Spanien, 08916
- Ikke rekrutterer endnu
- Investigative Site ES011
-
Barcelona, Spanien, 08035
- Ikke rekrutterer endnu
- Investigative Site ES003
-
Barcelona, Spanien, 08011
- Rekruttering
- Investigative Site ES002
-
Las Palmas de Gran Canaria, Spanien, 35016
- Rekruttering
- Investigative Site ES014
-
Madrid, Spanien, 28041
- Rekruttering
- Investigative Site ES008
-
Madrid, Spanien, 28034
- Ikke rekrutterer endnu
- Investigative Site ES006
-
Madrid, Spanien, 28040
- Ikke rekrutterer endnu
- Investigative Site ES012
-
Madrid, Spanien, 28009
- Rekruttering
- Investigative Site ES016
-
Madrid, Spanien, 28040
- Rekruttering
- Investigative Site ES007
-
Madrid, Spanien, 28050
- Rekruttering
- Investigative Site ES013
-
Palma de Mallorca, Spanien, 07120
- Ikke rekrutterer endnu
- Investigative Site ES005
-
Santander, Spanien, 39008
- Rekruttering
- Investigative Site ES009
-
Seville, Spanien, 41009
- Ikke rekrutterer endnu
- Investigative Site ES010
-
Valencia, Spanien, 46009
- Ikke rekrutterer endnu
- Investigative Site ES015
-
Valencia, Spanien, 46010
- Ikke rekrutterer endnu
- Investigative Site ES017
-
Valencia, Spanien, 46014
- Rekruttering
- Investigative Site ES001
-
Zaragoza, Spanien, 50009
- Rekruttering
- Investigative Site ES004
-
-
-
-
-
Linköping, Sverige, 58185
- Ikke rekrutterer endnu
- Investigative Site SE003
-
Lund, Sverige, 222 42
- Rekruttering
- Investigative Site SE001
-
Stockholm, Sverige, 17176
- Rekruttering
- Investigative Site SE002
-
-
-
-
-
Goyang-si, Sydkorea, 10408
- Rekruttering
- Investigative Site KR004
-
Seongnam-si, Sydkorea, 13496
- Rekruttering
- Investigative Site KR007
-
Seongnam-si, Sydkorea, 13620
- Rekruttering
- Investigative Site KR005
-
Seoul, Sydkorea, 06591
- Ikke rekrutterer endnu
- Investigative Site KR008
-
Seoul, Sydkorea, 03080
- Rekruttering
- Investigative Site KR002
-
Seoul, Sydkorea, 05505
- Rekruttering
- Investigative Site KR001
-
Seoul, Sydkorea, 03722
- Rekruttering
- Investigative Site KR006
-
Seoul, Sydkorea, 06351
- Rekruttering
- Investigative Site KR003
-
-
-
-
-
Berlin, Tyskland, 10365
- Ikke rekrutterer endnu
- Investigative Site DE018
-
Berlin, Tyskland, 13353
- Rekruttering
- Investigative Site DE020
-
Bochum, Tyskland, 44791
- Rekruttering
- Investigative Site DE003
-
Bonn, Tyskland, 53127
- Ikke rekrutterer endnu
- Investigative Site DE019
-
Cologne, Tyskland, D-50937
- Rekruttering
- Investigative Site DE008
-
Dresden, Tyskland, 01307
- Ikke rekrutterer endnu
- Investigative Site DE001
-
Düsseldorf, Tyskland, 40225
- Ikke rekrutterer endnu
- Investigative Site DE013
-
Essen, Tyskland, 45147
- Rekruttering
- Investigative Site DE004
-
Frankfurt, Tyskland, 60488
- Rekruttering
- Investigative Site DE005
-
Freiburg im Breisgau, Tyskland, 79106
- Rekruttering
- Investigative Site DE016
-
Göttingen, Tyskland, 37075
- Ikke rekrutterer endnu
- Investigative Site DE017
-
Halle, Tyskland, 06120
- Ikke rekrutterer endnu
- Investigative Site DE002
-
Hamburg, Tyskland, 20251
- Rekruttering
- Investigative Site DE007
-
Hamburg, Tyskland, 22763
- Rekruttering
- Investigative Site DE006
-
Leipzig, Tyskland, 04103
- Ikke rekrutterer endnu
- Investigative Site DE009
-
Munich, Tyskland, 81377
- Ikke rekrutterer endnu
- Investigative Site DE015
-
München, Tyskland, 81737
- Rekruttering
- Investigative Site DE014
-
Nuremberg, Tyskland, 90419
- Rekruttering
- Investigative Site DE010
-
Ulm, Tyskland, 89081
- Rekruttering
- Investigative Site DE011
-
-
-
-
-
Graz, Østrig, 8036
- Ikke rekrutterer endnu
- Investigative Site AT005
-
Innsbruck, Østrig, 06020
- Rekruttering
- Investigative Site AT002
-
Linz, Østrig, 04010
- Rekruttering
- Investigative Site AT004
-
Salzburg, Østrig, 05020
- Rekruttering
- Investigative Site AT003
-
-
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
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:
- 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
Exclusion Criteria:
- 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
- Known active CNS metastases
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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: Dobbelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: INCB161734 plus chemotherapy
INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements. |
Oral; tablet The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Andre navne:
|
|
Eksperimentel: Placebo plus chemotherapy
Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements. |
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Andre navne:
Oral; tablet |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to approximately 3 years
|
Defined as the time from the date of randomization to the date of death due to any cause. |
Up to approximately 3 years
|
|
Progression-free survival (PFS) by BICR
Tidsramme: Up to approximately 2 years
|
Defined as the time from the date of randomization to the date of the first documented progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause. |
Up to approximately 2 years
|
|
Objective Response by BICR
Tidsramme: Up to approximately 2 years
|
Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1. |
Up to approximately 2 years
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of Response (DOR) by BICR
Tidsramme: Up to approximately 2 years
|
Defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by BICR per RECIST v1.1 or death from any cause. |
Up to approximately 2 years
|
|
Disease control by BICR
Tidsramme: Up to approximately 2 years
|
Defined as having CR, PR, or stable disease (SD) as the best response determined by BICR per RECIST v1.1. |
Up to approximately 2 years
|
|
Progression-Free Survival (PFS) by investigator assessment
Tidsramme: Up to approximately 2 years
|
Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per RECIST v1.1 or death due to any cause. |
Up to approximately 2 years
|
|
Objective response by investigator assessment
Tidsramme: Up to approximately 2 years
|
Defined as CR or PR as determined by the investigator per RECIST v1.1. |
Up to approximately 2 years
|
|
DOR by investigator assessment
Tidsramme: Up to approximately 2 years
|
Defined as the time from the earliest date of documented response until earliest date of disease progression as determined by the investigator per RECIST v1.1 or death from any cause. |
Up to approximately 2 years
|
|
Disease control by investigator assessment
Tidsramme: Up to approximately 2 years
|
Defined as having CR, PR, or SD as the best response as determined by the investigator per RECIST v1.1. |
Up to approximately 2 years
|
|
Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to approximately 2 years and 30 days
|
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first. |
Up to approximately 2 years and 30 days
|
|
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Tidsramme: Up to approximately 2 years and 30 days
|
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment. |
Up to approximately 2 years and 30 days
|
|
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit
Tidsramme: Up to approximately 2 years
|
The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in cancer patients. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. |
Up to approximately 2 years
|
|
Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit
Tidsramme: Up to approximately 2 years
|
The EORTC QLQ-PAN26 consists of 26 questions that assess 9 pancreatic cancer-related and treatment-related symptoms (pain, eating-related items, cachexia, hepatic symptoms, side effects, altered bowel habits, ascites, indigestion, and flatulence) and 5 emotional domains specific to pancreatic cancer (body image, healthcare satisfaction, sexuality, fear of future health, and ability to plan for the future). The QLQ-PAN26 is scored on a 4-point scale that ranges from not at all to very much. |
Up to approximately 2 years
|
|
Change from baseline in EQ-5D-5L score at each postbaseline visit
Tidsramme: Up to approximately 2 years
|
The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health). |
Up to approximately 2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studieleder: Incyte Medical Monitor, Incyte Corporation
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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)
Studiestart
9. april 2026
Primær færdiggørelse (Anslået)
Primær færdiggørelse
15. september 2028
Studieafslutning (Anslået)
Studieafslutning
19. marts 2029
Datoer for studieregistrering
Først indsendt
Først indsendt
3. april 2026
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
3. april 2026
Først opslået (Faktiske)
Først opslået
13. april 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
30. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. oktober 2026
Sidst verificeret
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- INCB161734-303
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD-delingstidsramme
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD-delingsadgangskriterier
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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 .