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
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
588
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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
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Canberra, Australien, 02605
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Perth, Australien, 06009
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New South Wales
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Macquarie Park, New South Wales, Australien, 02109
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Queensland
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Chermside, Queensland, Australien, 04032
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Townsville, Queensland, Australien, 04814
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South Australia
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Woodville South, South Australia, Australien, 05011
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Victoria
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Melbourne, Victoria, Australien, 03000
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Melbourne, Victoria, Australien, 03004
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Richmond, Victoria, Australien, 03121
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Anderlecht, Belgien, 01070
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Brussels, Belgien, 01090
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Brussels, Belgien, 01200
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Edegem, Belgien, 02650
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Ghent, Belgien, 09000
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Gilly, Belgien, 06060
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Leuven, Belgien, 03000
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Liège, Belgien, 04000
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Yvoir, Belgien, 05530
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Hamilton, Ontario, Canada, L8V5C2
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Kingston, Ontario, Canada, K7L 5P9
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Toronto, Ontario, Canada, M5G 2M9
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Quebec
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Québec, Quebec, Canada, G1J 1Z4
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Herlev, Danmark, 02730
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Køge, Danmark, 04600
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Odense C, Danmark, 05000
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Vejle, Danmark, 07100
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Århus N, Danmark, 08200
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Dundee, Det Forenede Kongerige, DD1 9SY
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Guildford, Det Forenede Kongerige, GU2 7XX
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Headington, Det Forenede Kongerige, OX3 7LE
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Leeds, Det Forenede Kongerige, LS9 7TF
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London, Det Forenede Kongerige, NW3 2QG
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London, Det Forenede Kongerige, EC1A 7BE
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Manchester, Det Forenede Kongerige, M20 4BX
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Northwood, Det Forenede Kongerige, HA6 2RN
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HUS, Finland, 00290
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Turku, Finland, 20521
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
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California
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Fullerton, California, Forenede Stater, 92835
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La Jolla, California, Forenede Stater, 92093
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Long Beach, California, Forenede Stater, 90806-1650
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Los Angeles, California, Forenede Stater, 90089
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Colorado
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Florida
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Georgia
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Springfield, Illinois, Forenede Stater, 62702
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46250
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70121
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-9001
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Detroit, Michigan, Forenede Stater, 48201
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Grand Rapids, Michigan, Forenede Stater, 49503
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Ypsilanti, Michigan, Forenede Stater, 48197
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Minnesota
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Maple Grove, Minnesota, Forenede Stater, 55369
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39401
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Nevada
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Reno, Nevada, Forenede Stater, 89502
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Hackensack, New Jersey, Forenede Stater, 07601
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New York
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New York, New York, Forenede Stater, 10016
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New York, New York, Forenede Stater, 10128
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The Bronx, New York, Forenede Stater, 10461
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
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Cleveland, Ohio, Forenede Stater, 44106
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Columbus, Ohio, Forenede Stater, 43210
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Oregon
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Portland, Oregon, Forenede Stater, 97239
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
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Philadelphia, Pennsylvania, Forenede Stater, 19107
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105-2140
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
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Nashville, Tennessee, Forenede Stater, 37203
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Nashville, Tennessee, Forenede Stater, 37232-6309
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Texas
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Dallas, Texas, Forenede Stater, 75246
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Denison, Texas, Forenede Stater, 75020
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Houston, Texas, Forenede Stater, 77030
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San Antonio, Texas, Forenede Stater, 78240
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San Antonio, Texas, Forenede Stater, 78229
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
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Salem, Virginia, Forenede Stater, 24153
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Washington
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Olympia, Washington, Forenede Stater, 98506
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Seattle, Washington, Forenede Stater, 98104
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
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Brest, Frankrig, 29200
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Dijon, Frankrig, 21000
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Marseille, Frankrig, 13385
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Paris, Frankrig, 75013
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Paris, Frankrig, 75015
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Pessac, Frankrig, 33604
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Poitiers, Frankrig, 86021
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Villejuif, Frankrig, 94805
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Marneuli, Georgien, 03000
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Auckland, New Zealand, 01023
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Stavanger, Norge, 04011
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Trondheim, Norge, 07030
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Gdansk, Polen, 80-214
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Krakow, Polen, 31-501
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Badalona, Spanien, 08916
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Madrid, Spanien, 28041
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Madrid, Spanien, 28034
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Madrid, Spanien, 28040
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Madrid, Spanien, 28009
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Madrid, Spanien, 28040
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Seville, Spanien, 41009
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Valencia, Spanien, 46009
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Linköping, Sverige, 58185
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Stockholm, Sverige, 17176
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Seoul, Sydkorea, 06351
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Berlin, Tyskland, 10365
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Bonn, Tyskland, 53127
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Cologne, Tyskland, D-50937
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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
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
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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
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
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
Samarbejdspartnere
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)
9. april 2026
Primær færdiggørelse (Anslået)
15. september 2028
Studieafslutning (Anslået)
19. marts 2029
Datoer for studieregistrering
Først indsendt
3. april 2026
Først indsendt, der opfyldte QC-kriterier
3. april 2026
Først opslået (Faktiske)
13. april 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
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 .