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Alpelisib Plus Olaparib i platin-resistent/ildfast, højgradig serøs ovariecancer, uden kimlinie BRCA-mutation påvist

3. juni 2026 opdateret af: Novartis Pharmaceuticals

EPIK-O: Et fase III, multicenter, randomiseret (1:1), åbent, aktivt kontrolleret, undersøgelse for at vurdere effektiviteten og sikkerheden af ​​Alpelisib (BYL719) i kombination med Olaparib sammenlignet med enkeltstof cytotoksisk kemoterapi , hos deltagere uden detekteret germline BRCA-mutation, platin-resistent eller refraktær, højgradig serøs ovariecancer

Formålet med denne undersøgelse er at vurdere effektiviteten og sikkerheden af ​​kombinationen af ​​alpelisib og olaparib sammenlignet med cytotoksisk kemoterapi med enkeltstof hos patienter med platinresistent eller refraktær højgradig serøs ovariecancer, uden at der er påvist nogen kimlinie-BRCA-mutation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Denne undersøgelse vil omfatte voksne kvinder med platinresistent eller refraktær højgradig serøs ovariecancer, uden at der er påvist nogen kimlinie-BRCA-mutation. Deltagerne vil blive randomiseret i et 1:1-forhold til enten alpelisib plus olaparib eller cytotoksisk kemoterapi med enkeltstof (paclitaxel eller PLD) i denne åbne, aktive kontrollerede undersøgelse.

Deltagerne vil fortsætte med at modtage undersøgelsesbehandling indtil sygdomsprogression, uacceptabel toksicitet, der udelukker yderligere behandling, eller indtil seponering af undersøgelsesbehandling på grund af en anden årsag. Efter behandlingsophør vil alle deltagere gå ind i opfølgningsperioden efter behandlingen, som består af et sikkerhedsopfølgningsbesøg og et 9 ugers postprogressionsbesøg. Når de har gennemført opfølgningen efter behandling, vil deltagerne derefter gå ind i overlevelsesopfølgningsperioden.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

358

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1012AAR
        • Novartis Investigative Site
      • Caba, Argentina, C1015ABO
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1125ABD
        • Novartis Investigative Site
  • Australien
      • Sydney, Australien, 2031
        • Novartis Investigative Site
    • South Australia
      • Bedford Park, South Australia, Australien, 5041
        • Novartis Investigative Site
    • Victoria
      • Shepparton, Victoria, Australien, 3630
        • Novartis Investigative Site
  • Belgien
      • Brussels, Belgien, 1000
        • Novartis Investigative Site
      • Leuven, Belgien, 3000
        • Novartis Investigative Site
      • Namur, Belgien, 5000
        • Novartis Investigative Site
  • Brasilien
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilien, 30130-100
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 04014-002
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Novartis Investigative Site
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Novartis Investigative Site
  • Danmark
      • Herlev, Danmark, DK-2730
        • Novartis Investigative Site
      • Odense C, Danmark, 5000
        • Novartis Investigative Site
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige, G12 0YN
        • Novartis Investigative Site
      • London, Det Forenede Kongerige, SE1 9RT
        • Novartis Investigative Site
      • Manchester, Det Forenede Kongerige, M20 2BX
        • Novartis Investigative Site
  • Finland
      • Kuopio, Finland, FIN-70211
        • Novartis Investigative Site
      • Tampere, Finland, FIN-33521
        • Novartis Investigative Site
      • Turku, Finland, FIN 20521
        • Novartis Investigative Site
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
        • Arizona Oncology Associates
      • Phoenix, Arizona, Forenede Stater, 85016
        • HonorHealth
    • Florida
      • Fort Myers, Florida, Forenede Stater, 33901
        • Florida Cancer Specialists
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Florida Cancer Specialists
    • Maryland
      • Silver Spring, Maryland, Forenede Stater, 20904
        • Maryland Oncology Hematology P A
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Ctr
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Oncology Hematology Care Inc
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57106
        • Avera Cancer Institute
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Tennessee Oncology
    • Texas
      • Amarillo, Texas, Forenede Stater, 79124
        • Texas Oncology
      • Bedford, Texas, Forenede Stater, 76022
        • Texas Oncology P A
      • San Antonio, Texas, Forenede Stater, 78217
        • Texas Oncology P A
      • Tyler, Texas, Forenede Stater, 75702
        • Texas Oncology Northeast Texas
  • Frankrig
      • Besançon, Frankrig, 25030
        • Novartis Investigative Site
      • Lyon, Frankrig, 69373
        • Novartis Investigative Site
      • Paris, Frankrig, 75012
        • Novartis Investigative Site
      • Pierre-Bénite, Frankrig, 69495
        • Novartis Investigative Site
      • Villejuif, Frankrig, 94800
        • Novartis Investigative Site
  • Holland
      • Eindhoven, Holland, 5623 EJ
        • Novartis Investigative Site
  • Italien
      • Milan, Italien, 20141
        • Novartis Investigative Site
      • Naples, Italien, 80131
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italien, 40138
        • Novartis Investigative Site
    • FI
      • Florence, FI, Italien, 50134
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italien, 20133
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italien, 00168
        • Novartis Investigative Site
    • VI
      • Vicenza, VI, Italien, 36100
        • Novartis Investigative Site
  • Kina
      • Beijing, Kina, 100036
        • Novartis Investigative Site
      • Jinan, Kina, 250012
        • Novartis Investigative Site
      • Shanghai, Kina, 200032
        • Novartis Investigative Site
      • Tianjin, Kina, 300480
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Novartis Investigative Site
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
        • Novartis Investigative Site
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88996
        • Novartis Investigative Site
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Novartis Investigative Site
  • Mexico
      • Mexico City, Mexico, 04700
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Novartis Investigative Site
  • Portugal
      • Loures, Portugal, 2674-514
        • Novartis Investigative Site
      • Porto, Portugal, 4200-072
        • Novartis Investigative Site
  • Rusland
      • Arkhangelsk, Rusland, 163045
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 168583
        • Novartis Investigative Site
  • Slovakiet
      • Bratislava, Slovakiet, 83310
        • Novartis Investigative Site
  • Spanien
      • Barcelona, Spanien, 08035
        • Novartis Investigative Site
      • Barcelona, Spanien, 08036
        • Novartis Investigative Site
      • Córdoba, Spanien, 14004
        • Novartis Investigative Site
      • Madrid, Spanien, 28034
        • Novartis Investigative Site
      • Valencia, Spanien, 46010
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Novartis Investigative Site
  • Sydkorea
      • Seoul, Sydkorea, 03080
        • Novartis Investigative Site
      • Seoul, Sydkorea, 03722
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 407219
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
  • Tjekkiet
      • Nový Jičín, Tjekkiet, 741 01
        • Novartis Investigative Site
      • Prague, Tjekkiet, 128 08
        • Novartis Investigative Site
    • Poruba
      • Ostrava, Poruba, Tjekkiet, 708 52
        • Novartis Investigative Site
  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 06520
        • Novartis Investigative Site
    • Karsiyaka
      • Izmir, Karsiyaka, Tyrkiet (Türkiye), 35575
        • Novartis Investigative Site
    • Sihhiye-Altindag
      • Ankara, Sihhiye-Altindag, Tyrkiet (Türkiye), 06230
        • Novartis Investigative Site
    • Yuregir
      • Adana, Yuregir, Tyrkiet (Türkiye), 01230
        • Novartis Investigative Site
  • Tyskland
      • Berlin, Tyskland, 13353
        • Novartis Investigative Site
      • Essen, Tyskland, 45136
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Tyskland, 68305
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Tyskland, 01307
        • Novartis Investigative Site
  • Østrig
      • Graz, Østrig, 8036
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, Østrig, 6020
        • Novartis Investigative Site

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

Beskrivelse

Inklusionskriterier:

  • Deltageren har histologisk bekræftet diagnose af højgradig serøs eller højgradig endometrioid ovariecancer, æggeledercancer eller primær peritoneal cancer
  • Målbar sygdom, dvs. mindst én målbar læsion pr. RECIST 1.1-kriterier (en læsion på et tidligere bestrålet sted kan kun tælles som en mållæsion, hvis der er tydelige tegn på progression siden bestrålingen)
  • Hvis der ikke er nogen målbar sygdom til stede, bør sygdommen kunne vurderes ved hjælp af Gynecologic Cancer Intergroup-kriterier (GCIC) for CA-125
  • Deltageren har ingen kimlinje-BRCA1/2-mutation som bestemt af en FDA-godkendt analyse.
  • Deltageren har en Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 0 eller 1
  • Deltageren har platin-resistent (progression inden for en til seks måneder efter endt platin-baseret behandling) eller platin-refraktær sygdom (progression under behandlingen eller inden for 4 uger efter den sidste dosis), hvor platin-baseret behandling ikke er en mulighed, ifølge GCIG 5th Ovarial Cancer Consensus Consensus Definitioner. Den platinbaserede kemoterapi-kur behøver ikke nødvendigvis at være den sidste kur, som deltageren modtog før studiestart.
  • Deltageren skal have modtaget mindst én men ikke mere end tre tidligere systemiske behandlingsregimer, og for hvem enkeltstof-kemoterapi er passende som næste behandlingslinje.
  • Deltageren har tilstrækkelig knoglemarv og organfunktion

Ekskluderingskriterier:

  • Deltageren har modtaget forudgående behandling med en hvilken som helst PI3K-, mTOR- eller AKT-hæmmer.
  • Deltageren bruger samtidig anden kræftbehandling
  • Deltageren er i en tilstand af tynd- eller tyktarmsobstruktion eller har anden svækkelse af mave-tarmfunktionen (GI) eller GI-sygdom
  • Deltageren er blevet opereret inden for 14 dage før påbegyndelse af studielægemidlet eller er ikke kommet sig efter større bivirkninger
  • Deltageren er ikke kommet sig over alle toksiciteter 5 relateret til tidligere anticancerterapier til baseline eller NCI CTCAE Version 4.03 Grade ≤1. Undtagelse fra dette kriterium: deltagere med enhver grad af alopeci får lov til at deltage i undersøgelsen.
  • Deltagere med nedsat leverfunktion og Child Pugh scorer B eller C
  • Deltageren har modtaget strålebehandling ≤ 4 uger eller begrænset feltstråling til palliation ≤ 2 uger før randomisering, og som ikke er kommet sig til baseline, grad 1 eller bedre efter relaterede bivirkninger af en sådan terapi (med undtagelse af alopeci).
  • Deltageren har en kendt overfølsomhed over for nogen af ​​undersøgelsens lægemidler eller hjælpestoffer

Andre inklusion/udelukkelseskriterier kan være gældende

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
Eksperimentel: Alpelisib+olaparib
Alpelisib (200 mg once daily after food) and Olaparib (200 mg twice daily) were both administered orally on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle.
Medicin: Alpelisib
Alpelisib was administered at 200 mg orally once daily following food on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle
Andre navne:
  • BYL719
Medicin: Olaparib
Olaparib was administered at 200 mg orally twice daily irrespective of meals on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle.
Aktiv komparator: Paclitaxel or Pegylated liposomal doxorubicin
Paclitaxel (80 mg/m²) was administered as a weekly intravenous infusion on Days 1, 8, 15, and 22 of each 28-day cycle, or Pegylated liposomal doxorubicin (40-50 mg/m² at physician discretion) was administered as an intravenous infusion once every 28 days starting on Cycle 1 Day 1.
Medicin: Paclitaxel
Paclitaxel (80 mg/m²) was administered as a weekly intravenous infusion on Days 1, 8, 15, and 22 of each 28-day cycle.
Medicin: Pegylated liposomal doxorubicin (PLD)
Pegylated liposomal doxorubicin (40-50 mg/m² at physician discretion) was administered as an intravenous infusion once every 28 days starting on Cycle 1 Day 1.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival (PFS) Based on Blinded Independent Review Committee (BIRC) Assessment Using RECIST 1.1 Criteria
Tidsramme: From randomization until the date of the first documented progression or death due to any cause, whichever comes first, assessed up to approximately 21 months

Progression-free survival (PFS) was defined as the time from randomization to the first documented disease progression or death from any cause, as determined by blinded independent review committee (BIRC) assessment. Participants without an event were censored at the date of their last adequate tumor assessment. Clinical deterioration without objective radiologic evidence was not considered disease progression in the primary efficacy analysis.

Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including baseline), with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of non-target lesions.
From randomization until the date of the first documented progression or death due to any cause, whichever comes first, assessed up to approximately 21 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: From randomization until death, assessed up to approximately 44 months
Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a participant is not known to have died, then OS will be censored at the latest date the participant was known to be alive
From randomization until death, assessed up to approximately 44 months
Overall Response Rate (ORR) With Confirmed Response Based on BIRC Assessment According to RECIST 1.1 Criteria
Tidsramme: Up to approximately 21 months

Overall Response Rate (ORR) was defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR) by blinded independent review committee (BIRC) assessment as per RECIST 1.1 criteria:

  • CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.
  • PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 21 months
Clinical Benefit Rate (CBR) With Confirmed Response Based on BIRC Assessment According to RECIST 1.1
Tidsramme: Up to approximately 21 months
Clinical benefit rate (CBR) with confirmed response was defined as the percentage of participants whose best overall response was a confirmed CR or PR, or stable disease (SD) maintained for at least 24 weeks. CR, PR, and SD were determined by BIRC according to RECIST 1.1 criteria.
Up to approximately 21 months
Time to Response (TTR) Based on BIRC Assessment and According to RECIST 1.1
Tidsramme: From the date of randomization to the first documented response, assessed through Month 12
Time to response (TTR) was defined as the interval from randomization to the first documented occurrence of either complete response (CR) or partial response (PR), which was subsequently confirmed (using the date of initial response, not the confirmation date). CR and PR were determined based on tumor response data assessed by BIRC according to RECIST 1.1 criteria.
From the date of randomization to the first documented response, assessed through Month 12
Duration of Response (DOR) With Confirmed Response Based on BIRC Assessment and According to RECIST 1.1
Tidsramme: From first documented response to first documented progression or death, assessed up to approximately 21 months
Duration of response (DOR) with confirmed response was calculated only for participants whose best overall response was a confirmed complete response (CR) or confirmed partial response (PR), based on tumor response data assessed by BIRC according to RECIST 1.1. The start date was the date of the first documented CR or PR (i.e., the initial response date, not the confirmation date), and the end date was the date of first documented disease progression or death due to underlying cancer. Participants without progression or cancer-related death were censored at the date of their last adequate tumor assessment.
From first documented response to first documented progression or death, assessed up to approximately 21 months
Time to Definitive Deterioration of the Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Tidsramme: Up to approximately 18 months
Performance status (PS) was evaluated using the ECOG scale, which comprises six grades (0 to 5), where 0 represents fully active and 5 represents death. Time to definitive deterioration in ECOG PS was defined as the interval from randomization to the date when ECOG PS worsened by at least one category from baseline and remained worsened. Deterioration was considered definitive if there was no subsequent improvement to the baseline category or better. Participants were censored if no definitive deterioration occurred before the earlier of: (i) the analysis cut-off date or (ii) initiation of a new anti-neoplastic therapy. The censoring date was the date of the last PS assessment prior to the cut-off or start of new therapy.
Up to approximately 18 months
Number of Participants With Dose Interruptions and Dose Reductions
Tidsramme: From randomization until end of treatment, assessed up to approximately 18 months
The number of participants with dose reductions/interruptions was assessed and summarized by study treatment.
From randomization until end of treatment, assessed up to approximately 18 months
Dose Intensity for Alpelisib and Olaparib
Tidsramme: From randomization until end of treatment, assessed up to approximately 18 months
Dose intensity was computed as the ratio of actual cumulative dose received to actual duration of exposure and summarized by study treatment.
From randomization until end of treatment, assessed up to approximately 18 months
Dose Intensity for Paclitaxel
Tidsramme: From randomization until end of treatment, assessed up to approximately 18 months
Dose intensity was computed as the ratio of actual cumulative dose received to actual duration of exposure and summarized by study treatment.
From randomization until end of treatment, assessed up to approximately 18 months
Dose Intensity for Pegylated Liposomal Doxorubicin
Tidsramme: From randomization until end of treatment, assessed up to approximately 18 months
Dose intensity was computed as the ratio of actual cumulative dose received to actual duration of exposure and summarized by study treatment.
From randomization until end of treatment, assessed up to approximately 18 months
Area Under the Curve Calculated to the End of a Dosing Interval (Tau) at Steady-state (AUCtau) of Alpelisib and Olaparib
Tidsramme: Day 8 Cycle 1 (pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post dose), Day 1 on Cycle 2, 4 and 8 (pre-dose)
The AUCtau will be assessed to characterize the pharmacokinetics of alpelisib when administered in combination of olaparib
Day 8 Cycle 1 (pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post dose), Day 1 on Cycle 2, 4 and 8 (pre-dose)
Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast)of Alpelisib and Olaparib
Tidsramme: Day 8 Cycle 1 (pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post dose), Day 1 on Cycle 2, 4 and 8 (pre-dose)
The AUClast will be assessed to characterize the pharmacokinetics of alpelisib when administered in combination of olaparib
Day 8 Cycle 1 (pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post dose), Day 1 on Cycle 2, 4 and 8 (pre-dose)
Maximum Concentration (Cmax) of Alpelisib and Olaparib
Tidsramme: Day 8 Cycle 1 (pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post dose), Day 1 on Cycle 2, 4 and 8 (pre-dose)
The Cmax will be assessed to characterize the pharmacokinetics of alpelisib when administered in combination of olaparib
Day 8 Cycle 1 (pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post dose), Day 1 on Cycle 2, 4 and 8 (pre-dose)
Time to Reach Maximum Concentration (Tmax) of Alpelisib and Olaparib
Tidsramme: Day 8 Cycle 1 (pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post dose), Day 1 on Cycle 2, 4 and 8 (pre-dose)
The Tmax will be assessed to characterize the pharmacokinetics of alpelisib when administered in combination of olaparib
Day 8 Cycle 1 (pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post dose), Day 1 on Cycle 2, 4 and 8 (pre-dose)
Time to Definitive Deterioration by 10% in FACT-O Trial Outcomes Index (TOI) Score
Tidsramme: Baseline, up to 15 months
The Functional Assessment of Cancer Therapy-Ovarian (FACT O) is a validated instrument that evaluates quality of life in patients with ovarian cancer. The Trial Outcome Index (TOI) of the FACT-O combines Physical Well Being (PWB), Functional Well Being (FWB), and the Ovarian Cancer Subscale (OCS), and its scores range from 0 to 100, with higher scores indicating better quality of life and physical/functional status. Time to definitive deterioration by 10% in FACT O TOI is defined as the time from randomization to the first occurrence of at least a 10% worsening from baseline with no subsequent improvement above this threshold, or death. Participants without an event before analysis cut off or before starting another anticancer therapy were censored at their last adequate assessment. Time to deterioration was estimated using the Kaplan-Meier method.
Baseline, up to 15 months

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

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

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)

22. juli 2021

Primær færdiggørelse (Faktiske)

21. april 2023

Studieafslutning (Faktiske)

19. januar 2026

Datoer for studieregistrering

Først indsendt

25. januar 2021

Først indsendt, der opfyldte QC-kriterier

25. januar 2021

Først opslået (Faktiske)

28. januar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CBYL719K12301
  • 2024-510782-42-00 (Registry Identifier: EU CT Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Novartis er forpligtet til at dele med kvalificerede eksterne forskere, adgang til data på patientniveau og understøttende kliniske dokumenter fra kvalificerede undersøgelser. Disse anmodninger gennemgås og godkendes af et uafhængigt bedømmelsespanel på grundlag af videnskabelig fortjeneste. Alle opgivne data er anonymiseret for at respektere privatlivets fred for patienter, der har deltaget i forsøget i overensstemmelse med gældende love og regler.

Tilgængeligheden af ​​denne forsøgsdata er i overensstemmelse med kriterierne og processen beskrevet på www.clinicalstudydatarequest.com

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 .

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