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En undersøgelse af Azenosertib (ZN-c3) versus forsøgslederens valg af kemoterapi hos patienter med platinresistente højgradige serøse æggestok-, primære peritoneale- eller æggelederkræft med positivt udtryk for Cyclin E1-protein (ASPENOVA)

6. november 2026 opdateret af: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Et randomiseret, åbent-mærket fase 3-studie af Azenosertib versus forskerens valg af kemoterapi i platina-resistent højgradigt serøst ovarie-, primært peritonealt eller fimbrie-rørskræft positiv for Cyclin E1-proteinekspression

This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A Phase 3 study to evaluate the efficacy, safety, and overall clinical benefit of azenosertib (ZN-c3) compared with Investigator's choice of chemotherapy in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Azenosertib is a selective and orally bioavailable inhibitor of WEE1. In HGSOC, high Cyclin E1 protein drives replication stress and increases tumor reliance on WEE1-mediated G2/M checkpoint control. Treating tumor cells with azenosertib promotes premature cell cycle progression leading to increased replication stress and accumulation of DNA damage pushing cells to mitotic catastrophe resulting in tumor cell death.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

420

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Ikke rekrutterer endnu
        • Site 2105
      • Córdoba, Argentina, X5000AAW
        • Ikke rekrutterer endnu
        • Site 2101
      • Córdoba, Argentina, X5008AAC
        • Ikke rekrutterer endnu
        • Site 2102
      • Rosario, Argentina, S2002
        • Ikke rekrutterer endnu
        • Site 2104
      • San Miguel de Tucumán, Argentina, T4000GTB
        • Ikke rekrutterer endnu
        • Site 2103
  • Australien
    • New South Wales
      • Randwick, New South Wales, Australien, 2031
        • Rekruttering
        • Site 1101
      • Westmead, New South Wales, Australien, 2145
        • Ikke rekrutterer endnu
        • Site 1105
      • Wollongong, New South Wales, Australien, 2500
        • Ikke rekrutterer endnu
        • Site 1108
    • Queensland
      • South Brisbane, Queensland, Australien, 4101
        • Ikke rekrutterer endnu
        • Site 1107
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Rekruttering
        • Site 1102
    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
        • Ikke rekrutterer endnu
        • Site 1103
      • Subiaco, Western Australia, Australien, 6008
        • Ikke rekrutterer endnu
        • Site 1104
  • Belgien
      • Brussels, Belgien, 1020
        • Rekruttering
        • Site 3002
      • Edegem, Belgien, 2650
        • Ikke rekrutterer endnu
        • Site 3003
      • Leuven, Belgien, 3000
        • Ikke rekrutterer endnu
        • Site 3001
  • Brasilien
      • Belo Horizonte, Brasilien, 30.360-680
        • Ikke rekrutterer endnu
        • Site 2209
      • Curitiba, Brasilien, 80810-050
        • Ikke rekrutterer endnu
        • Site 2208
      • Goiânia, Brasilien, 74605-070
        • Ikke rekrutterer endnu
        • Site 2207
      • Porto Alegre, Brasilien, 90110-270
        • Ikke rekrutterer endnu
        • Site 2201
      • Porto Alegre, Brasilien, 90470-340
        • Ikke rekrutterer endnu
        • Site 2203
      • Rio de Janeiro, Brasilien, 22281-100
        • Ikke rekrutterer endnu
        • Site 2205
      • Rio de Janeiro, Brasilien, 22775-001
        • Ikke rekrutterer endnu
        • Site 2206
      • São José do Rio Preto, Brasilien, 15090-000
        • Ikke rekrutterer endnu
        • Site 2202
      • São Paulo, Brasilien, 01401-002
        • Ikke rekrutterer endnu
        • Site 2204
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L3
        • Ikke rekrutterer endnu
        • Site 0207
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Ikke rekrutterer endnu
        • Site 0205
      • Toronto, Ontario, Canada, M5G 2M9
        • Ikke rekrutterer endnu
        • Site 0201
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Ikke rekrutterer endnu
        • Site 0203
      • Montreal, Quebec, Canada, H4A 3J1
        • Ikke rekrutterer endnu
        • Site 0206
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Ikke rekrutterer endnu
        • Site 0202
  • Danmark
      • Aalborg, Danmark, 9000
        • Ikke rekrutterer endnu
        • Site 3203
      • Copenhagen, Danmark, 2100
        • Ikke rekrutterer endnu
        • Site 3201
      • Roskilde, Danmark, 4000
        • Ikke rekrutterer endnu
        • Site 3202
  • Estland
      • Tallinn, Estland, 13419
        • Ikke rekrutterer endnu
        • Site 3302
      • Tartu, Estland, 50406
        • Ikke rekrutterer endnu
        • Site 3301
  • Finland
      • Kuopio, Finland, 70210
        • Ikke rekrutterer endnu
        • Site 3403
      • Oulu, Finland, 90220
        • Ikke rekrutterer endnu
        • Site 3401
      • Tampere, Finland, 33520
        • Ikke rekrutterer endnu
        • Site 3402
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
        • Ikke rekrutterer endnu
        • Site 0107
    • California
      • Antioch, California, Forenede Stater, 94531
        • Ikke rekrutterer endnu
        • Site 0110
      • Beverly Hills, California, Forenede Stater, 90212
        • Rekruttering
        • Site 0104
      • Fountain Valley, California, Forenede Stater, 92708
        • Rekruttering
        • Site 0122
      • San Francisco, California, Forenede Stater, 94109
        • Ikke rekrutterer endnu
        • Site 0115
      • Torrance, California, Forenede Stater, 90505
        • Rekruttering
        • Site 0101
    • Florida
      • Orlando, Florida, Forenede Stater, 32806
        • Rekruttering
        • Site 0116
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21215
        • Rekruttering
        • Site 0123
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Ikke rekrutterer endnu
        • Site 0111
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43026
        • Ikke rekrutterer endnu
        • Site 0108
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Ikke rekrutterer endnu
        • Site 0105
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Ikke rekrutterer endnu
        • Site 0113
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Rekruttering
        • Site 0109
      • Willow Grove, Pennsylvania, Forenede Stater, 19090
        • Ikke rekrutterer endnu
        • Site 0114
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Ikke rekrutterer endnu
        • Site 0112
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Rekruttering
        • Site 0117
  • Frankrig
      • Besançon, Frankrig, 25000
        • Ikke rekrutterer endnu
        • Site 3508
      • Brest, Frankrig, 29609
        • Ikke rekrutterer endnu
        • Site 3502
      • Dijon, Frankrig, 21079
        • Ikke rekrutterer endnu
        • Site 3507
      • Lyon, Frankrig, 69373
        • Ikke rekrutterer endnu
        • Site 3504
      • Marseille, Frankrig, 13273
        • Ikke rekrutterer endnu
        • Site 3510
      • Paris, Frankrig, 75014
        • Ikke rekrutterer endnu
        • Site 3503
      • Pierre-Bénite, Frankrig, 69495
        • Ikke rekrutterer endnu
        • Site 3501
      • Saint-Herblain, Frankrig, 44805
        • Ikke rekrutterer endnu
        • Site 3509
      • Strasbourg, Frankrig, 67098
        • Ikke rekrutterer endnu
        • Site 3505
      • Villejuif, Frankrig, 94805
        • Rekruttering
        • Site 3506
  • Holland
      • Amsterdam, Holland, 1105 AZ
        • Ikke rekrutterer endnu
        • Site 3901
      • Groningen, Holland, 9700 RB
        • Ikke rekrutterer endnu
        • Site 3902
      • Nijmegen, Holland, 6525 GA
        • Ikke rekrutterer endnu
        • Site 3903
  • Irland
      • Cork, Irland, T12 DC4A
        • Ikke rekrutterer endnu
        • Site 3703
      • Dublin, Irland, D08 NYH1
        • Ikke rekrutterer endnu
        • Site 3702
      • Dublin, Irland, D07 R2WY
        • Ikke rekrutterer endnu
        • Site 3704
  • Israel
      • Ashdod, Israel, 7747629
        • Ikke rekrutterer endnu
        • Site 5009
      • Haifa, Israel, 3109601
        • Ikke rekrutterer endnu
        • Site 5002
      • Holon, Israel, 5822012
        • Ikke rekrutterer endnu
        • Site 5007
      • Jerusalem, Israel, 9103102
        • Ikke rekrutterer endnu
        • Site 5001
      • Nahariya, Israel, 2210001
        • Ikke rekrutterer endnu
        • Site 5006
      • Petah Tikva, Israel, 49100
        • Ikke rekrutterer endnu
        • Site 5003
      • Safed, Israel, 1311001
        • Ikke rekrutterer endnu
        • Site 5008
      • Tel Aviv, Israel, 6423906
        • Ikke rekrutterer endnu
        • Site 5004
      • Tel HaShomer, Israel, 5265601
        • Ikke rekrutterer endnu
        • Site 5005
  • Italien
      • Bologna, Italien, 40138
        • Ikke rekrutterer endnu
        • Site 3801
      • Florence, Italien, 50134
        • Ikke rekrutterer endnu
        • Site 3814
      • Milan, Italien, 20132
        • Ikke rekrutterer endnu
        • Site 3805
      • Milan, Italien, 20141
        • Ikke rekrutterer endnu
        • Site 3804
      • Milan, Italien, 20159
        • Ikke rekrutterer endnu
        • Site 3803
      • Milan, Italien, 20121
        • Ikke rekrutterer endnu
        • Site 3812
      • Milan, Italien, 20133
        • Ikke rekrutterer endnu
        • Site 3813
      • Naples, Italien, 80131
        • Ikke rekrutterer endnu
        • Site 3802
      • Pisa, Italien, 56126
        • Ikke rekrutterer endnu
        • Site 3808
      • Prato, Italien, 59100
        • Ikke rekrutterer endnu
        • Site 3807
      • Roma, Italien, 00185
        • Ikke rekrutterer endnu
        • Site 3810
      • Rome, Italien, 00168
        • Ikke rekrutterer endnu
        • Site 3806
      • Torino, Italien, 10128
        • Ikke rekrutterer endnu
        • Site 3811
      • Vicenza, Italien, 36100
        • Ikke rekrutterer endnu
        • Site 3809
  • Kroatien
      • Rijeka, Kroatien, 51000
        • Ikke rekrutterer endnu
        • Site 3103
      • Zagreb, Kroatien, 10000
        • Ikke rekrutterer endnu
        • Site 3101
      • Zagreb, Kroatien, 10000
        • Ikke rekrutterer endnu
        • Site 3102
  • Polen
      • Gdansk, Polen, 80-214
        • Ikke rekrutterer endnu
        • Site 4005
      • Krakow, Polen, 30-348
        • Ikke rekrutterer endnu
        • Site 4006
      • Krakow, Polen, 31-531
        • Ikke rekrutterer endnu
        • Site 4008
      • Poznan, Polen, 61-848
        • Ikke rekrutterer endnu
        • Site 4004
      • Poznan, Polen, 61-866
        • Ikke rekrutterer endnu
        • Site 4002
      • Siedlce, Polen, 08-110
        • Ikke rekrutterer endnu
        • Site 4007
      • Szczecin, Polen, 70-111
        • Ikke rekrutterer endnu
        • Site 4003
  • Portugal
      • Coimbrã, Portugal, 3000-075
        • Ikke rekrutterer endnu
        • Site 4106
      • Lisbon, Portugal, 1099-023
        • Ikke rekrutterer endnu
        • Site 4104
      • Lisbon, Portugal, 1400-038
        • Ikke rekrutterer endnu
        • Site 4103
      • Lisbon, Portugal, 1500-650
        • Ikke rekrutterer endnu
        • Site 4102
      • Lisbon, Portugal, 1649-035
        • Ikke rekrutterer endnu
        • Site 4105
      • Porto, Portugal, 4200-072
        • Ikke rekrutterer endnu
        • Site 4101
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Rekruttering
        • Site 0137
  • Spanien
      • Barcelona, Spanien, 08028
        • Ikke rekrutterer endnu
        • Site 4201
      • Barcelona, Spanien, 08041
        • Ikke rekrutterer endnu
        • Site 4205
      • Madrid, Spanien, 28040
        • Ikke rekrutterer endnu
        • Site 4206
      • Madrid, Spanien, 28034
        • Rekruttering
        • Site 4202
      • Málaga, Spanien, 29011
        • Ikke rekrutterer endnu
        • Site 4203
      • Vigo, Spanien, 36212
        • Rekruttering
        • Site 4204
  • Sydkorea
      • Daegu, Sydkorea, 42601
        • Rekruttering
        • Site 1203
      • Goyang-si, Sydkorea, 10408
        • Rekruttering
        • Site 1206
      • Seoul, Sydkorea, 03722
        • Rekruttering
        • Site 1205
      • Seoul, Sydkorea, 03080
        • Rekruttering
        • Site 1202
      • Seoul, Sydkorea, 06351
        • Rekruttering
        • Site 1201
      • Seoul, Sydkorea, 06273
        • Rekruttering
        • Site 1204
  • Taiwan
      • Taichung, Taiwan, 40705
        • Ikke rekrutterer endnu
        • Site 1301
      • Taipei, Taiwan, 11217
        • Ikke rekrutterer endnu
        • Site 1302
  • Tyskland
      • Berlin, Tyskland, D-13353
        • Ikke rekrutterer endnu
        • Site 3602
      • Bonn, Tyskland, 53127
        • Ikke rekrutterer endnu
        • Site 3603
      • Dresden, Tyskland, 01307
        • Ikke rekrutterer endnu
        • Site 3601
      • Düsseldorf, Tyskland, 40225
        • Ikke rekrutterer endnu
        • Site 3605
      • Tübingen, Tyskland, 72076
        • Ikke rekrutterer endnu
        • Site 3604

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

Kvinde

Beskrivelse

Inclusion Criteria:

  1. Female age ≥ 18 years

  2. High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer

  3. Measurable disease per RECIST Version 1.1

  4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1

  5. The subject's tumor tissue must be positive for cyclin E1 protein expression per the Sponsor's clinically validated cyclin E1 IHC investigational, in vitro diagnostic assay

  6. Prior Therapy:

    1. Subject must have platinum-resistant disease
    2. One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
    3. Prior bevacizumab treatment is required, if eligible per standard of care
    4. Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
    5. Prior mirvetuximab treatment is required, if eligible per standard of care

  7. Adequate hematologic and organ function during the screening period

Exclusion Criteria:

  1. History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease-free. Exceptions include appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome.

  2. Subjects with primary platinum-refractory disease.

  3. Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC.

  4. A serious illness or medical condition(s) including, but not limited to, the following:

    1. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
    2. Acute kidney injury requiring intervention, or presence of indwelling urinary catheter or percutaneous nephrostomy.
    3. Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.
    4. Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months before randomization, or recurrent paracentesis or thoracentesis within 6 weeks before randomization.
    5. Active, uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal, or antiviral) must have completed such treatment and the infection must be considered controlled/resolved (and afebrile) by the Investigator for at least 7 days before randomization
    6. Myocardial impairment of any cause resulting in heart failure by New York Heart Association criteria (Class II, III or IV).
    7. Medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results

  5. Any of the following treatment interventions within the specified time frame before randomization:

    1. Hospitalization within 14 days
    2. Major surgery within 28 days
    3. Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter)
    4. Radiation therapy within 21 days
    5. Autologous or allogeneic stem cell transplant within 3 months
    6. Current use of any other investigational drug therapy < 28 days or 5 half-lives (whichever is shorter)

  6. Inability to discontinue treatment with prescription or nonprescription drugs that are prohibited per protocol.

  7. Inability to discontinue consumption of food and herbal supplements that are prohibited per protocol

  8. Prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.

  9. Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation).

  10. Subjects who are immunocompromised or HIV-positive on highly active anti-retroviral therapy

  11. Subjects with known active hepatitis B or hepatitis C infection

  12. Individuals who are judged by the Investigator to be unsuitable as study subjects

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: Eksperimentel: Arm C Forskerens valg af kemoterapi i den dosis, der er defineret af protokollen
Medicin: Investigator's choice of Chemotherapy

The investigator will select the chemotherapy in accordance with the protocol defined requirements. The possible choices as defined by the protocol:

  • Paclitaxel
  • Gemcitabine
  • Pegylated liposomal doxorubicin (PLD)
  • Topotecan

The selected chemotherapy will be administered intravenously
Eksperimentel: Arm A Azenosertib 400 mg administered daily on a 5 days on, 2 days off intermittent schedule
Medicin: Azenosertib

Azenosertib 400 mg will be administered orally.

Andre navne:
  • ZN-c3

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression free survival (PFS) per RECIST v1.1 as assessed by Investigator
Tidsramme: Up to approximately 24 months from the enrollment of the last subject

Time from randomization to the first documented tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Up to approximately 24 months from the enrollment of the last subject

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival
Tidsramme: Up to approximately 24 months from the enrollment of the last subject

Time from randomization until death due to any cause
Up to approximately 24 months from the enrollment of the last subject
PFS per RECIST 1.1 as assessed by blinded independent central review (ICR)
Tidsramme: Up to approximately 24 months from the enrollment of the last subject

Time from randomization to the first documented tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Up to approximately 24 months from the enrollment of the last subject
Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator
Tidsramme: Up to approximately 24 months from the enrollment of the last subject

Proportion of patients who attain a partial response (PR) or complete response (CR) per RECIST v1.1
Up to approximately 24 months from the enrollment of the last subject
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire score (EORTC QLQ)-Core 30 (C30) at each post baseline visit
Tidsramme: Up to approximately 24 months from the enrollment of the last subject

Assess changes over time in cancer-specific and patient-reported outcome instruments assessing global health status/quality of life, functional domains, and symptom burden.
Up to approximately 24 months from the enrollment of the last subject
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire score (EORTC QLQ)-OV28 at each post baseline visit
Tidsramme: Up to approximately 24 months from the enrollment of the last subject

Assess changes over time in cancer-specific and patient-reported outcome instruments assessing global health status/quality of life, functional domains, and symptom burden.
Up to approximately 24 months from the enrollment of the last subject
Change from baseline in EQ-5D-5L score at each post baseline visit
Tidsramme: Up to approximately 24 months from the enrollment of the last subject

Assess changes over time in cancer-specific and patient-reported outcome instruments assessing global health status/quality of life, functional domains, and symptom burden.
Up to approximately 24 months from the enrollment of the last subject
Number of Subjects experiencing treatment emergent adverse events (TEAEs)
Tidsramme: Up to approximately 24 months and 30 days from the enrollment of the last subject

Assess adverse events occurring for the first time or worsening of a pre-existing event during the treatment period until 30 days after the last dose of study drug
Up to approximately 24 months and 30 days from the enrollment of the last subject

Samarbejdspartnere og efterforskere

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

Sponsor

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Samarbejdspartnere

GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)

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)

17. april 2026

Primær færdiggørelse (Anslået)

31. maj 2028

Studieafslutning (Anslået)

30. april 2030

Datoer for studieregistrering

Først indsendt

26. marts 2026

Først indsendt, der opfyldte QC-kriterier

16. april 2026

Først opslået (Faktiske)

22. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZN-c3-020
  • GOG-3147 (Anden identifikator: GOG Foundation, Inc.)
  • ENGOT-ov109 (Anden identifikator: ENGOT)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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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