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Sotorasib og Panitumumab versus Investigator's Choice for deltagere med Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (CodeBreak300)

25. juni 2026 opdateret af: Amgen

Et fase 3 multicenter, randomiseret, åbent, aktivt kontrolleret studie af Sotorasib og Panitumumab versus Investigator's Choice (Trifluridin og Tipiracil eller Regorafenib) til behandling af tidligere behandlede metastaserende kolorektal cancerpatienter med Kirsten Rat Sarcoma (KRAS) p. Mutation

Formålet med undersøgelsen er at sammenligne progressionsfri overlevelse (PFS) hos tidligere behandlede deltagere med Kirsten rottesarkom (KRAS) p.G12C muteret kolorektal cancer (CRC), der modtager sotorasib 240 mg én gang dagligt (QD) og panitumumab vs investigators valg ( trifluridin og tipiracil eller regorafenib) og sotorasib 960 mg én gang dagligt (QD) og panitumumab vs investigators valg (trifluridin og tipiracil eller regorafenib).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

160

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Chris OBrien Lifehouse
      • St Leonards, New South Wales, Australien, 2065
        • GenesisCare -North Shore (Oncology)
      • Westmead, New South Wales, Australien, 2145
        • Westmead Hospital
    • South Australia
      • Woodville South, South Australia, Australien, 5011
        • The Queen Elizabeth Hospital
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • London, Det Forenede Kongerige, SW3 6JJ
        • Royal Marsden Hospital
      • London, Det Forenede Kongerige, NW3 2QG
        • Royal Free Hospital
      • Maidstone, Det Forenede Kongerige, ME16 9QQ
        • Maidstone Hospital
      • Northwood, Det Forenede Kongerige, HA6 2RN
        • Mount Vernon Cancer Centre
      • Sutton, Det Forenede Kongerige, SM2 5PT
        • Royal Marsden Hospital
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35209
        • Central Alabama Research
    • California
      • Duarte, California, Forenede Stater, 91010
        • City of Hope National Medical Center
      • Orange, California, Forenede Stater, 92868
        • University of California Irvine
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20016
        • Johns Hopkins University School Of Medicine
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32256
        • Cancer Specialists of North Florida
      • Miami Lakes, Florida, Forenede Stater, 33014
        • Lakes Research LLC
    • Georgia
      • Marietta, Georgia, Forenede Stater, 30060
        • Northwest Georgia Oncology Centers PC
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106-0995
        • University of Michigan
      • Farmington Hills, Michigan, Forenede Stater, 48334
        • Revive Research Institute
      • Lansing, Michigan, Forenede Stater, 48912
        • Sparrow Clinical Research Institute
      • Sterling Heights, Michigan, Forenede Stater, 48314
        • Revive Research Institute
    • New York
      • Syracuse, New York, Forenede Stater, 13210
        • Upstate University Hospital
      • White Plains, New York, Forenede Stater, 10601
        • White Plains Hospital Center for Cancer Care
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Moses H Cone Memorial Hospital
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • The Mark H Zangmeister Center
    • Pennsylvania
      • Lancaster, Pennsylvania, Forenede Stater, 17601
        • Lancaster General Hospital Ann B Barshinger Cancer Institute
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, Forenede Stater, 77025
        • Kelsey Research Foundation
      • Houston, Texas, Forenede Stater, 77089
        • Best Cancer Care & Hematology
      • Kingwood, Texas, Forenede Stater, 77339
        • LUMI Research
  • Frankrig
      • Lyon Cédex 3, Frankrig, 69437
        • Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot
      • Montpellier, Frankrig, 34298
        • Institut régional du Cancer Montpellier
      • Paris, Frankrig, 75015
        • Hôpital Europeén Georges Pompidou
      • Pessac, Frankrig, 33604
        • Hôpital Haut -lévêque
  • Grækenland
      • Athens, Grækenland, 11527
        • General Hospital of Athens Laiko
      • Athens, Grækenland, 15123
        • Hygeia Hospital
      • Athens, Grækenland, 11528
        • Evgenidio Hospital I Agia Trias
      • Heraklion - Crete, Grækenland, 71500
        • University Hospital of Heraklion
      • Pátrai, Grækenland, 26504
        • University Hospital of Patras
      • Thessaloniki, Grækenland, 55236
        • Agios Loukas Clinic
      • Thessaloniki, Grækenland, 54007
        • Theagenion Anticancer Hospital
  • Italien
      • Brescia, Italien, 25124
        • Istituto Ospedaliero Fondazione Poliambulanza
      • Catania, Italien, 95122
        • Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima
      • Confreria (CN), Italien, 12100
        • Azienda Ospedaliera Santa Croce E Carle
      • Florence, Italien, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Genova, Italien, 16132
        • Ospedale Policlinico San Martino IRCCS
      • La Spezia, Italien, 19100
        • Azienda Sanitaria Locale 5 Spezzino Ospedale S Andrea
      • Lecce, Italien, 73100
        • Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
      • Milan, Italien, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italien, 20162
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
      • Monserrato CA, Italien, 09042
        • Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
      • Naples, Italien, 80131
        • Azienda Ospedaliero Universitaria Luigi Vanvitelli
      • Naples, Italien, 80131
        • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
      • Novara, Italien, 28100
        • Azienda Ospedaliero Universitaria Maggiore della Carità
      • Padova, Italien, 35128
        • Istituto Oncologico Veneto IRCCS
      • Pisa, Italien, 56126
        • Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
      • Potenza, Italien, 85100
        • Azienda Ospedaliera San Carlo
      • Reggio Emilia, Italien, 42100
        • Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova
      • Roma, Italien, 00168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Italien, 00184
        • Azienda Ospedaliera San Giovanni Addolorata
      • Roma (RM), Italien, 00133
        • Fondazione Policlinico Tor Vergata
      • Tricase, Italien, 73039
        • Azienda Ospedaliera Cardinale Giovanni Panico
      • Vicenza, Italien, 36100
        • Azienda Unita Locale Socio Sanitaria Berica 8
  • Japan
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japan, 480-1195
        • Aichi Medical University Hospital
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Chiba Cancer Center
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Hyōgo
      • Akashi-shi, Hyōgo, Japan, 673-8558
        • Hyogo Cancer Center
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • St Marianna University Hospital
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
    • Osaka
      • Osaka, Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Saitama Cancer Center
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of Japanese Foundation For Cancer Research
  • Mexico
      • Mexico City, Mexico, 06700
        • Trials In Medicine SC
    • Mexico City
      • Mexico City, Mexico City, Mexico, 03100
        • Health Pharma Professional Research Sa de Cv
      • Mexico City, Mexico City, Mexico, 06760
        • Superare Centro de Infusion SA de CV
  • Spanien
      • Madrid, Spanien, 28046
        • Hospital Universitario La Paz
    • Andalusia
      • Córdoba, Andalusia, Spanien, 14004
        • Hospital Universitario Reina Sofia
      • Granada, Andalusia, Spanien, 18014
        • Hospital Universitario Virgen de las Nieves
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Catalonia
      • Barcelona, Catalonia, Spanien, 08041
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Catalonia, Spanien, 08035
        • Hospital Universitari Vall D Hebron
    • Galicia
      • Ourense, Galicia, Spanien, 32005
        • Complexo Hospitalario Universitario de Ourense
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Hospital Universitario de Navarra
    • Valencia
      • Elche, Valencia, Spanien, 03203
        • Hospital General Universitario de Elche
      • Valencia, Valencia, Spanien, 46014
        • Hospital General Universitario de Valencia
  • Sydkorea
      • Seoul, Sydkorea, 03080
        • Seoul National University Hospital
      • Seoul, Sydkorea, 05505
        • Asan Medical Center
      • Seoul, Sydkorea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Sydkorea, 06351
        • Samsung Medical Center
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
  • Tyskland
      • Berlin, Tyskland, 13353
        • Charite Universitaetsmedizin Berlin, Charité Campus Virchow-Klinikum
      • Dresden, Tyskland, 01307
        • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
      • Göttingen, Tyskland, 37075
        • Universitaetsmedizin Goettingen - Georg-August-Universitaet
      • München, Tyskland, 81377
        • Klinikum der Universitaet Muenchen Campus Grosshadern
      • Tübingen, Tyskland, 72076
        • Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen

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 til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Deltageren har givet informeret samtykke/samtykke før påbegyndelse af undersøgelsesspecifikke aktiviteter/procedurer.
  • Alder ≥18 år.
  • Patologisk dokumenteret metastatisk kolorektalt adenokarcinom med Kirsten rottesarkom (KRAS) p.G12C mutation som bestemt ved central test.
  • Deltagerne vil have modtaget mindst 1 tidligere behandlingslinje for metastatisk sygdom. Deltagerne skal have modtaget og udviklet sig eller oplevet sygdomstilbagefald på eller efter fluoropyrimidin, irinotecan og oxaliplatin givet til metastatisk sygdom, medmindre deltageren efter investigatorens opfattelse ikke er kandidat til fluoropyrimidin, irinotecan eller oxaliplatin, i hvilket tilfælde Deltageren kan være berettiget efter en undersøgelsessamtale med Amgen medicinsk monitor, forudsat at deltageren har modtaget mindst én tidligere behandlingslinje for metastatisk sygdom, og forudsat at trifluridin og tipiracil eller regorafenib anses for at være den passende næste behandlingslinje for deltageren.
  • Målbar sygdom pr. responsevalueringskriterier i faste tumorer (RECIST) 1.1 kriterier. Tidligere udstrålede læsioner anses ikke for at kunne måles, medmindre de er udviklet efter stråling.
  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus på ≤2.
  • Forventet levetid på >3 måneder efter undersøgerens vurdering.

  • Tilstrækkelig hæmatologisk funktion og slutorganfunktion, defineret som følgende inden for 2 uger før cyklus 1 dag 1:

    • Absolut neutrofiltal (ANC) ≥1,5 x 10^9/L (uden understøttelse af granulocytkolonistimulerende faktor inden for 2 uger efter laboratorietest brugt til at bestemme egnethed).
    • Hæmoglobin ≥9,0 g/dL (uden transfusion inden for 2 uger efter laboratorietest brugt til at bestemme egnethed).
    • Blodpladeantal ≥100 x 10^9/L (uden transfusion inden for 2 uger efter laboratorietest brugt til at bestemme egnethed).
    • Aspartataminotransferase (AST) og alaninaminotransferase (ALT) ≤2,5 gange den øvre normalgrænse (ULN).
    • Serumbilirubin ≤1,0 x ULN. For deltagere med Gilberts sygdom, direkte bilirubin ≤1,0 x ULN.
    • International normaliseret ratio (INR) og aktiveret partiel tromboplastintid (eller partiel tromboplastintid) ≤1,5 ​​x ULN. Protrombintid (PT) ≤1,5 ​​x ULN kan bruges i stedet for INR til steder, hvis laboratorier ikke rapporterer INR.
    • Estimeret glomerulær filtrationshastighed baseret på ændring af diæt ved nyresygdom (MDRD) beregning ≥30 ml/min/1,73 m^2.
  • Fridericias korrektionsformel (QTcF) ≤470 msek.

Ekskluderingskriterier:

  • Aktive hjernemetastaser. Deltagere, der har fået fjernet hjernemetastaser eller har modtaget strålebehandling, der afsluttes mindst 4 uger før studiedag 1, er kvalificerede, hvis de opfylder alle følgende kriterier: a) resterende neurologiske symptomer grad ≤2; b) på stabile doser af dexamethason eller tilsvarende i mindst 2 uger, hvis det er relevant; og c) opfølgende magnetisk resonansbilleddannelse (MRI) udført inden for 28 dage efter dag 1 viser ingen progression eller nye læsioner.
  • Anamnese eller tilstedeværelse af hæmatologiske maligniteter, medmindre det behandles kurativt uden tegn på sygdom ≥2 år.

  • Anamnese med anden malignitet inden for de seneste 3 år, med følgende undtagelser:

    • Malignitet behandlet med kurativ hensigt og uden kendt aktiv sygdom til stede i ≥3 år før indskrivning og føltes at have lav risiko for tilbagefald af den behandlende læge.
    • Tilstrækkeligt behandlet ikke-melanom hudkræft eller lentigo maligna uden tegn på sygdom.
    • Tilstrækkeligt behandlet cervikal carcinom in situ uden tegn på sygdom.
    • Tilstrækkeligt behandlet duktalt brystcarcinom in situ uden tegn på sygdom.
    • Prostatisk intraepitelial neoplasi uden tegn på prostatacancer.
    • Tilstrækkeligt behandlet urothelial papillært non-invasivt karcinom eller karcinom in situ.
  • Leptomeningeal sygdom.
  • Betydelig gastrointestinal (GI) lidelse, der resulterer i betydelig malabsorption, behov for intravenøs (IV) næring eller manglende evne til at tage oral medicin.
  • Anamnese med interstitiel pneumonitis eller lungefibrose eller tegn på interstitiel pneumonitis eller pulmonal fibrose.
  • Betydelig kardiovaskulær sygdom, såsom New York Heart Association hjertesygdom (klasse II eller større), myokardieinfarkt inden for 6 måneder før randomisering, ustabile arytmier eller ustabil angina.
  • Tidligere behandling med en KRAS G12C-hæmmer.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm C: Efterforskerens valg
Deltagerne vil blive administreret trifluridin og tipiracil eller regorafenib
Medicin: Trifluridin og Tipiracil
Trifluridin og Tipiracil vil blive indgivet oralt
Andre navne:
  • Lonsurf
Medicin: Regorafenib
Regorafenib vil blive indgivet oralt
Andre navne:
  • Stivarga
Eksperimentel: Arm A: Sotorasib 960 mg QD + panitumumab
Medicin: Sotorasib
Sotorasib vil blive indgivet oralt
Andre navne:
  • AMG 510, Lumakras, Lumykras
Medicin: Panitumumab
Panitumumab vil blive administreret som intravenøs (IV) infusion
Andre navne:
  • Vectibix
Eksperimentel: Arm B: Sotorasib 240 mg QD + panitumumab
Medicin: Sotorasib
Sotorasib vil blive indgivet oralt
Andre navne:
  • AMG 510, Lumakras, Lumykras
Medicin: Panitumumab
Panitumumab vil blive administreret som intravenøs (IV) infusion
Andre navne:
  • Vectibix

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by BICR
Tidsramme: From randomization until DCO or death; median (min, max) time on trial was 6.23 (0.1, 14.0) months
PFS was defined as time from randomization until disease progression or death from any cause, whichever occurred first, for all participants. Progression was assessed using RECIST v1.1 per BICR.
From randomization until DCO or death; median (min, max) time on trial was 6.23 (0.1, 14.0) months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Approximately 3 years
OS was defined as time from randomization until death from any cause.
Approximately 3 years
Objective Response Rate (ORR) Per RECIST Version 1.1 as Assessed by BICR
Tidsramme: Approximately 3 years
Objective response was defined as best overall response (BOR) of complete response (CR) or partial response (PR), as defined by RECIST version 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. Responses were assessed based on BICR.
Approximately 3 years
Duration of Response (DOR) Per RECIST Version 1.1 as Assessed by BICR
Tidsramme: Approximately 3 years
DOR was defined as time from first evidence of PR or CR until progressive disease (PD) or death due to any cause, whichever occurs first. CR was defined as disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Approximately 3 years
Time to Response (TTR) as Assessed by BICR
Tidsramme: Approximately 3 years
TTR was defined as time from randomization to the first evidence of PR or CR based on BICR. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters.
Approximately 3 years
Disease Control Rate (DCR) as Assessed by BICR
Tidsramme: Approximately 3 years
DCR was defined as the percentage of participants with the BOR of CR, PR or stable disease (SD) of at least 7 weeks based on BICR. CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on trial (this includes baseline sum if that is the smallest on trial).
Approximately 3 years
PFS Per RECIST Version 1.1 as Based on Investigator Assessment
Tidsramme: Approximately 3 years
PFS by investigator assessment was defined as the time from randomization until PD or death due to any cause, whichever occurs first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions.
Approximately 3 years
ORR Per RECIST Version 1.1 as Based on Investigator Assessment
Tidsramme: Approximately 3 years
ORR was defined as BOR of CR or PR, as defined by RECIST version 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. Responses were assessed based on investigator assessment.
Approximately 3 years
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsramme: Approximately 3 years
TEAEs were events with onset after the administration of the first dose of any trial treatment up to EOT or 30 days of the last dose of any trial treatment, or prior to first dose of crossed over treatment, whichever occurred earlier. Clinically significant changes in vital signs, and clinical laboratory tests were included as TEAEs.
Approximately 3 years
Change From Baseline in Fatigue Severity as Measured by Item 3 of the Brief Fatigue Inventory - Short Form (BFI-SF)
Tidsramme: Baseline and Week 8
Item 3 of the BFI-SF recorded a participants' fatigue on a scale from 0 to 10. Higher scores indicated a higher severity of fatigue. An increase in score from baseline indicated a worsening of fatigue. A decrease in score from baseline indicated an improvement in fatigue.
Baseline and Week 8
Change From Baseline in Pain Severity as Measured by Item 3 of the Brief Pain Inventory - Short Form (BPI-SF)
Tidsramme: Baseline and Week 8
Item 3 of the BPI-SF recorded a participants' pain on a scale from 1 to 10, where pain was mild (score of 1 to 4), moderate (score of 5 to 6), or severe (score of 7 to 10). An increase in score from baseline indicated a worsening of pain. A decrease in score from baseline indicates a lessening of pain.
Baseline and Week 8
Change From Baseline in Physical Functioning as Measured by the Physical Function Domain of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire - Core 30 Item (EORTC QLQ-C30)
Tidsramme: Baseline and Week 8
The physical function domain of the EORTC QLQ-C30 assessed a participants' quality of life regarding their physical function on a scale from 1 to 4, with higher scores indicating a worse outcome. An increase in score from baseline indicated a worsening of physical functioning. A decrease in score from baseline indicated an improvement in physical functioning.
Baseline and Week 8
Change From Baseline in Global Health Status as Measured by Questions 29 and 30 of the EORTC QLQ-C30
Tidsramme: Baseline and Week 8
Questions 29 and 30 of the EORTC QLQ-C30 assessed a participants' global health status on a scale from 1 to 7, with higher scores indicating a better outcome. An increase in score from baseline indicated an improvement in global health status. A decrease in score from baseline indicated a worsening in global health status.
Baseline and Week 8
Change From Baseline for All Subscales of the BFI-SF
Tidsramme: Baseline and Week 8
The BFI-SF was a questionnaire that included 3 items to assess fatigue severity and 5 items to assess interference due to fatigue, with each item reported on a numeric rating scale from 0 to 10. Higher scores indicated a higher severity of fatigue. An increase in score from baseline indicated a worsening of fatigue. A decrease in score from baseline indicated an improvement in fatigue.
Baseline and Week 8
Change From Baseline for All Subscales of the BPI-SF
Tidsramme: Baseline and Week 8
The BPI-SF was a 9-item questionnaire which included 2 body diagrams, four items to assess pain severity, four items to assess pain interference and one question about percentage of pain relief by analgesics. The level of pain and pain interference assessed could be divided into categories based on score of mild (1 to 4), moderate (5 to 6), and severe (7 to 10). An increase in score from baseline indicated a worsening of pain. A decrease in score from baseline indicated a lessening of pain.
Baseline and Week 8
Change From Baseline for All Subscales and Domains of EORTC QLQ-C30
Tidsramme: Baseline and Week 8
The EORTC QLQ-C30 was a self-reporting 30-item generic instrument which assessed 5 functional domains (physical, role, emotional, cognitive, social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and a global health status/quality of life (QOL) scale. Higher scores indicated a worse outcome. An increase in score from baseline indicated a worsening of outcome. A decrease in score from baseline indicated an improvement in outcome.
Baseline and Week 8
Average Score of VAS Scores as Measured by EQ-5D-5L
Tidsramme: Baseline and Week 8
The EQ-5D-5L questionnaire was a 2-page, standardized instrument for use as a measure of health outcome. It was comprised of a 5-dimension health status measure and a visual analogue scale. The 5-dimension health status measure evaluates: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale recorded the participant's self-rated health on a vertical, visual analogue scale where the endpoints were labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Baseline and Week 8
Average Score on Single Question on Symptom Bother GP5 From Functional Assessment of Cancer Therapy - General (FACT-G)
Tidsramme: Approximately 2 years
The GP5 from the FACT-G was a single item included in the Physical Well-Being subscale of the FACT-G. Responses to the item: "I am bothered by side effects of treatment" are rated on a 5-point Likert scale from "not at all" to "very much".
Approximately 2 years
Average Score of Patient Global Impression of Change (PGIC)
Tidsramme: Approximately 2 years
The PGIC scale consisted of one item which measures the participants' perception of change in their condition relative to the beginning of the trial. Responses are rated on a 7-item response scale ranging from very much improved to very much worse.
Approximately 2 years
Maximum Plasma Concentration (Cmax) of Sotorasib
Tidsramme: Approximately 2 years
Approximately 2 years
Cmax of Panitumumab
Tidsramme: Approximately 2 years
Approximately 2 years
Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib
Tidsramme: Approximately 2 years
Approximately 2 years
AUC of Panitumumab
Tidsramme: Approximately 2 years
Approximately 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Efterforskere

  • Studieleder: MD, Amgen

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.

Generelle publikationer

Hjælpsomme links

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)

19. april 2022

Primær færdiggørelse (Faktiske)

16. juli 2025

Studieafslutning (Faktiske)

14. april 2026

Datoer for studieregistrering

Først indsendt

6. januar 2022

Først indsendt, der opfyldte QC-kriterier

6. januar 2022

Først opslået (Faktiske)

20. januar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20190172
  • 2024-511187-81-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Afidentificerede individuelle patientdata for variabler, der er nødvendige for at løse det specifikke forskningsspørgsmål i en godkendt anmodning om datadeling

IPD-delingstidsramme

Anmodninger om datadeling i forbindelse med denne undersøgelse vil blive overvejet begyndende 18 måneder efter, at undersøgelsen er afsluttet, og enten 1) produktet og indikationen er blevet udstedt markedsføringstilladelse i både USA og Europa eller 2) den kliniske udvikling af produktet og/eller indikationen ophører og dataene vil ikke blive indsendt til de regulerende myndigheder. Der er ingen slutdato for berettigelse til at indsende en anmodning om datadeling for denne undersøgelse.

IPD-delingsadgangskriterier

Kvalificerede forskere kan indsende en anmodning, der indeholder forskningsmålene, Amgen-produktet/-erne og Amgen-undersøgelsen/-undersøgelserne i omfang, endepunkter/resultater af interesse, statistisk analyseplan, datakrav, publikationsplan og forskerens/forskernes kvalifikationer. Generelt imødekommer Amgen ikke eksterne anmodninger om individuelle patientdata med det formål at revurdere sikkerheds- og effektivitetsspørgsmål, der allerede er behandlet i produktmærkningen. Anmodninger gennemgås af et udvalg af interne rådgivere. Hvis den ikke godkendes, vil et uafhængigt datadelingspanel mægle og træffe den endelige beslutning. Efter godkendelse vil oplysninger, der er nødvendige for at løse forskningsspørgsmålet, blive leveret i henhold til vilkårene i en datadelingsaftale. Dette kan omfatte anonymiserede individuelle patientdata og/eller tilgængelige understøttende dokumenter, der indeholder fragmenter af analysekode, hvor det er angivet i analysespecifikationerne. Yderligere detaljer er tilgængelige på URL'en nedenfor.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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 .

Abonner