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AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) (VECTRA-01)

24. august 2026 oppdatert av: AstraZeneca

A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Approximately 670 adult participants with mCRPC will be randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI, or radium-223). They will receive their assigned treatment until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Tumor evaluation scans will continue after treatment discontinuation until radiographically confirmed progression or death.

All patients will be followed for survival until the end of the study. An Independent Data Monitoring Committee (IDMC) composed of independent experts will be convened to monitor the safety and scientific integrity of the study.

Studietype

Intervensjonell

Registrering (Antatt)

670

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Australia
      • Darlinghurst, Australia, 2010
        • Har ikke rekruttert ennå
        • Research Site
      • Kurralta Park, Australia, 5037
        • Har ikke rekruttert ennå
        • Research Site
      • Melbourne, Australia, 3000
        • Har ikke rekruttert ennå
        • Research Site
      • Murdoch, Australia, WA6150
        • Har ikke rekruttert ennå
        • Research Site
  • Brasil
      • São Paulo, Brasil, 05652-900
        • Har ikke rekruttert ennå
        • Research Site
      • São Paulo, Brasil, 01308-050
        • Har ikke rekruttert ennå
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Har ikke rekruttert ennå
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Har ikke rekruttert ennå
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Har ikke rekruttert ennå
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Har ikke rekruttert ennå
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Har ikke rekruttert ennå
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Rekruttering
        • Research Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Har ikke rekruttert ennå
        • Research Site
  • Finland
      • Kuopio, Finland, 70210
        • Har ikke rekruttert ennå
        • Research Site
  • Forente stater
    • Alabama
      • Dothan, Alabama, Forente stater, 36303
        • Rekruttering
        • Research Site
    • Arizona
      • Phoenix, Arizona, Forente stater, 85004
        • Har ikke rekruttert ennå
        • Research Site
    • California
      • Duarte, California, Forente stater, 91010
        • Har ikke rekruttert ennå
        • Research Site
      • Irvine, California, Forente stater, 92618
        • Har ikke rekruttert ennå
        • Research Site
      • Newport Beach, California, Forente stater, 92660
        • Rekruttering
        • Research Site
      • San Francisco, California, Forente stater, 94143
        • Har ikke rekruttert ennå
        • Research Site
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Har ikke rekruttert ennå
        • Research Site
    • Florida
      • Miami, Florida, Forente stater, 33165
        • Rekruttering
        • Research Site
    • Illinois
      • O'Fallon, Illinois, Forente stater, 62269
        • Har ikke rekruttert ennå
        • Research Site
    • Louisiana
      • Metairie, Louisiana, Forente stater, 70006
        • Rekruttering
        • Research Site
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Tilbaketrukket
        • Research Site
      • Grand Rapids, Michigan, Forente stater, 49503
        • Har ikke rekruttert ennå
        • Research Site
    • Missouri
      • St Louis, Missouri, Forente stater, 63104
        • Har ikke rekruttert ennå
        • Research Site
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68130
        • Rekruttering
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87109
        • Har ikke rekruttert ennå
        • Research Site
    • New York
      • New Hyde Park, New York, Forente stater, 11042
        • Har ikke rekruttert ennå
        • Research Site
      • New York, New York, Forente stater, 10065
        • Har ikke rekruttert ennå
        • Research Site
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Har ikke rekruttert ennå
        • Research Site
      • Dayton, Ohio, Forente stater, 45415
        • Har ikke rekruttert ennå
        • Research Site
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • Har ikke rekruttert ennå
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15232
        • Har ikke rekruttert ennå
        • Research Site
    • South Carolina
      • Myrtle Beach, South Carolina, Forente stater, 29572
        • Har ikke rekruttert ennå
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Har ikke rekruttert ennå
        • Research Site
    • Texas
      • Houston, Texas, Forente stater, 77042
        • Rekruttering
        • Research Site
    • Utah
      • Salt Lake City, Utah, Forente stater, 84106
        • Har ikke rekruttert ennå
        • Research Site
    • Washington
      • Tacoma, Washington, Forente stater, 98405
        • Har ikke rekruttert ennå
        • Research Site
  • Frankrike
      • Villejuif, Frankrike, 94800
        • Har ikke rekruttert ennå
        • Research Site
  • India
      • Bangalore, India, 560017
        • Har ikke rekruttert ennå
        • Research Site
      • Gurgaon, India, 122002
        • Har ikke rekruttert ennå
        • Research Site
      • Gurgaon, India, 122001
        • Har ikke rekruttert ennå
        • Research Site
      • Navi Mumbai, India, 410210
        • Har ikke rekruttert ennå
        • Research Site
  • Israel
      • Haifa, Israel, 3109601
        • Har ikke rekruttert ennå
        • Research Site
      • Jerusalem, Israel, 00000
        • Har ikke rekruttert ennå
        • Research Site
      • Petah Tikva, Israel, 4941492
        • Har ikke rekruttert ennå
        • Research Site
      • Ramat Gan, Israel, 52621
        • Har ikke rekruttert ennå
        • Research Site
      • Tel Aviv, Israel, 64239
        • Har ikke rekruttert ennå
        • Research Site
  • Japan
      • Chiba, Japan, 260-8717
        • Har ikke rekruttert ennå
        • Research Site
      • Chūōku, Japan, 104-0045
        • Har ikke rekruttert ennå
        • Research Site
      • Fukuoka, Japan, 812-8582
        • Rekruttering
        • Research Site
      • Hamamatsu, Japan, 431-3192
        • Har ikke rekruttert ennå
        • Research Site
      • Kamakura-shi, Japan, 247-8533
        • Har ikke rekruttert ennå
        • Research Site
      • Kanazawa, Japan, 920-8641
        • Rekruttering
        • Research Site
      • Kashiwa, Japan, 227-8577
        • Har ikke rekruttert ennå
        • Research Site
      • Kobe, Japan, 650-0047
        • Har ikke rekruttert ennå
        • Research Site
      • Kyoto, Japan, 606-8507
        • Har ikke rekruttert ennå
        • Research Site
      • Sapporo, Japan, 060-8638
        • Rekruttering
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Har ikke rekruttert ennå
        • Research Site
      • Yokohama, Japan, 236-0004
        • Har ikke rekruttert ennå
        • Research Site
  • Kina
      • Beijing, Kina, 100142
        • Har ikke rekruttert ennå
        • Research Site
      • Beijing, Kina, 100034
        • Har ikke rekruttert ennå
        • Research Site
      • Chengdu, Kina, 610041
        • Har ikke rekruttert ennå
        • Research Site
      • Chongqing, Kina, 400030
        • Har ikke rekruttert ennå
        • Research Site
      • Fuzhou, Kina, 350005
        • Har ikke rekruttert ennå
        • Research Site
      • Guangzhou, Kina, 510060
        • Har ikke rekruttert ennå
        • Research Site
      • Guangzhou, Kina, 510630
        • Har ikke rekruttert ennå
        • Research Site
      • Guangzhou, Kina, 510120
        • Har ikke rekruttert ennå
        • Research Site
      • Hangzhou, Kina, 310022
        • Har ikke rekruttert ennå
        • Research Site
      • Hangzhou, Kina, 310003
        • Har ikke rekruttert ennå
        • Research Site
      • Hangzhou, Kina, 310014
        • Har ikke rekruttert ennå
        • Research Site
      • Jinan, Kina, 250117
        • Har ikke rekruttert ennå
        • Research Site
      • Nanjing, Kina, 210006
        • Har ikke rekruttert ennå
        • Research Site
      • Nanjing, Kina, 210029
        • Suspendert
        • Research Site
      • Shanghai, Kina, 200032
        • Har ikke rekruttert ennå
        • Research Site
      • Shanghai, Kina, 200025
        • Har ikke rekruttert ennå
        • Research Site
      • Shenyang, Kina, 110001
        • Har ikke rekruttert ennå
        • Research Site
      • Wuhan, Kina, 430022
        • Har ikke rekruttert ennå
        • Research Site
      • Wuhan, Kina, 430030
        • Har ikke rekruttert ennå
        • Research Site
      • Xi'an, Kina, 710061
        • Har ikke rekruttert ennå
        • Research Site
  • Polen
      • Gdansk, Polen, 80-214
        • Har ikke rekruttert ennå
        • Research Site
      • Krakow, Polen, 31-501
        • Har ikke rekruttert ennå
        • Research Site
      • Warsaw, Polen, 02-781
        • Har ikke rekruttert ennå
        • Research Site
  • Spania
      • Barcelona, Spania, 8035
        • Har ikke rekruttert ennå
        • Research Site
      • Barcelona, Spania, 08025
        • Har ikke rekruttert ennå
        • Research Site
      • L'Hospitalet de Llobregat, Spania, 08908
        • Har ikke rekruttert ennå
        • Research Site
      • Madrid, Spania, 28041
        • Har ikke rekruttert ennå
        • Research Site
      • Majadahonda, Spania, 28222
        • Har ikke rekruttert ennå
        • Research Site
      • Málaga, Spania, 29009
        • Har ikke rekruttert ennå
        • Research Site
      • Santiago de Compostela, Spania, 15706
        • Har ikke rekruttert ennå
        • Research Site
  • Storbritannia
      • London, Storbritannia, EC1A 7BE
        • Har ikke rekruttert ennå
        • Research Site
      • Middlesbrough, Storbritannia, TS4 3BW
        • Har ikke rekruttert ennå
        • Research Site
      • Southampton, Storbritannia, SO16 6YD
        • Har ikke rekruttert ennå
        • Research Site
      • Truro, Storbritannia, TR1 3LJ
        • Har ikke rekruttert ennå
        • Research Site
  • Sverige
      • Stockholm, Sverige, 17176
        • Har ikke rekruttert ennå
        • Research Site
      • Umeå, Sverige, 901 85
        • Har ikke rekruttert ennå
        • Research Site
  • Sør -Korea
      • Goyang-si, Sør -Korea, 10408
        • Har ikke rekruttert ennå
        • Research Site
      • Seoul, Sør -Korea, 3722
        • Har ikke rekruttert ennå
        • Research Site
      • Seoul, Sør -Korea, 03080
        • Har ikke rekruttert ennå
        • Research Site
      • Seoul, Sør -Korea, 06591
        • Har ikke rekruttert ennå
        • Research Site
      • Seoul, Sør -Korea, 5505
        • Har ikke rekruttert ennå
        • Research Site
      • Seoul, Sør -Korea, 6351
        • Har ikke rekruttert ennå
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833401
        • Har ikke rekruttert ennå
        • Research Site
      • Taipei, Taiwan, 11259
        • Har ikke rekruttert ennå
        • Research Site
      • Taipei, Taiwan, 10002
        • Har ikke rekruttert ennå
        • Research Site
      • Taipei, Taiwan, 11217
        • Har ikke rekruttert ennå
        • Research Site
      • Taoyuan, Taiwan, 333
        • Har ikke rekruttert ennå
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Har ikke rekruttert ennå
        • Research Site
      • Bangkok, Thailand, 10210
        • Har ikke rekruttert ennå
        • Research Site
  • Tyrkia (Türkiye)
      • Ankara, Tyrkia (Türkiye), 06530
        • Har ikke rekruttert ennå
        • Research Site
      • Ankara, Tyrkia (Türkiye), 06620
        • Har ikke rekruttert ennå
        • Research Site
      • Istanbul, Tyrkia (Türkiye), 34098
        • Har ikke rekruttert ennå
        • Research Site
      • Istanbul, Tyrkia (Türkiye), 34752
        • Har ikke rekruttert ennå
        • Research Site
  • Tyskland
      • Augsburg, Tyskland, 86156
        • Har ikke rekruttert ennå
        • Research Site
      • Berlin, Tyskland, 13353
        • Har ikke rekruttert ennå
        • Research Site
      • Bonn, Tyskland, 53127
        • Har ikke rekruttert ennå
        • Research Site
      • Cologne, Tyskland, 50937
        • Har ikke rekruttert ennå
        • Research Site
      • Dresden, Tyskland, 01307
        • Har ikke rekruttert ennå
        • Research Site
      • Essen, Tyskland, 45122
        • Har ikke rekruttert ennå
        • Research Site
      • Jena, Tyskland, 07747
        • Har ikke rekruttert ennå
        • Research Site
      • Karlsruhe, Tyskland, 76133
        • Tilbaketrukket
        • Research Site
      • München, Tyskland, 81675
        • Har ikke rekruttert ennå
        • Research Site
      • Münster, Tyskland, 48149
        • Har ikke rekruttert ennå
        • Research Site
      • Nuremberg, Tyskland, 90419
        • Tilbaketrukket
        • Research Site
      • Rostock, Tyskland, 18057
        • Har ikke rekruttert ennå
        • Research Site
      • Stuttgart, Tyskland, 70174
        • Har ikke rekruttert ennå
        • Research Site
      • Tübingen, Tyskland, 72076
        • Har ikke rekruttert ennå
        • Research Site
      • Würzburg, Tyskland, 97080
        • Har ikke rekruttert ennå
        • Research Site
  • Østerrike
      • Linz, Østerrike, 4020
        • Har ikke rekruttert ennå
        • Research Site
      • Salzburg, Østerrike, 5020
        • Har ikke rekruttert ennå
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • ≥ 18 years of age.
  • Diagnosis of adenocarcinoma of prostate.
  • Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone.
  • Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and/or non-measurable) that is suitable for repeated assessment by CT and/or MRI and/or bone scan.
  • Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.
  • Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC.
  • Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).
  • Positive PSMA PET/CT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).
  • ECOG performance status of 0 to 2.
  • Adequate organ and bone marrow function as described in study protocol.
  • Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
  • Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.

Exclusion Criteria:

  • Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).
  • Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.
  • Receipt of > 6 cycles of PSMA-directed β-emitting therapeutic RC.
  • History of another primary malignancy, with exceptions.
  • Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.
  • Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
  • Clinically significant ECG abnormalities, with exceptions.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A
Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])
Legemiddel: Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])
IV
Andre navn:
  • AZD2265, FPI-2265
Aktiv komparator: Arm B
Investigator's choice of cabazitaxel, ARPI, or radium-223
Legemiddel: Enzalutamid
Muntlig
Andre navn:
  • Xtandi
Legemiddel: Cabazitaxel
IV in combination with oral prednisone/prednisolone
Andre navn:
  • Jevtana
Legemiddel: Abiraterone
Oral in combination with prednisone/prednisolone
Andre navn:
  • Zytiga
Legemiddel: Radium-223
IV
Andre navn:
  • Xofigo
Legemiddel: Apalutamide
Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)
Andre navn:
  • Erleada
Legemiddel: Darolutamide
Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)
Andre navn:
  • Nubeqa
Legemiddel: Deutenzalutamide
Oral; available in China only

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Radiographic Progression-Free Survival (rPFS)
Tidsramme: From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months)
rPFS is defined as the time from randomisation to radiographic progression, as assessed by the BICR per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.
From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months)
Overall Survival (OS)
Tidsramme: From randomization until death from any cause (up to approximately 33 months)
OS is defined as the length of time from randomisation until the date of death due to any cause.
From randomization until death from any cause (up to approximately 33 months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: From randomization until first documented progression (radiographic, clinical, or PSA progression) or death in the absence of progression, whichever occurs first (up to approximately 33 months)
PFS is defined as the time from randomisation to the earliest of progression (defined as radiographic progression assessed by BICR per RECIST 1.1 and/or PCWG3 criteria, clinical progression, or PSA progression), or death due to any cause.
From randomization until first documented progression (radiographic, clinical, or PSA progression) or death in the absence of progression, whichever occurs first (up to approximately 33 months)
Assessment of PSA50 (≥50% prostate-specific antigen reduction)
Tidsramme: From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Proportion of participants achieving a >= 50% decrease in PSA from baseline.
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Assessment of PSA90 (≥90% prostate-specific antigen reduction)
Tidsramme: From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Proportion of participants achieving >=90% decrease in PSA from baseline.
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Duration of Response (DoR)
Tidsramme: From first documented response until progression per RECIST 1.1/PCWG3 by BICR, or death in the absence of progression, whichever occurs first (up to approximately 33 months)
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone) as determined by BICR or death in the absence of disease progression.
From first documented response until progression per RECIST 1.1/PCWG3 by BICR, or death in the absence of progression, whichever occurs first (up to approximately 33 months)
Symptomatic Skeletal Event-Free Survival (SSE-FS)
Tidsramme: From randomization until first symptomatic skeletal event or death from any cause, whichever occurs first (up to approximately 33 months)

SSE-FS is defined as the time from randomisation to the earliest of the following:

  • Use of radiation therapy to prevent or relieve skeletal symptoms.
  • Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).
  • Occurrence of spinal cord compression.
  • Orthopaedic surgical intervention for bone metastasis.
  • Death due to any cause.
From randomization until first symptomatic skeletal event or death from any cause, whichever occurs first (up to approximately 33 months)
Plasma concentrations of AZD2265
Tidsramme: Pre-dose and post-dose on Day 1 of Cycles 1 and 2; 3-24 hours post-dose on Cycle 1 Day 1 only (up to approximately 7 weeks)
Plasma concentrations of AZD2265 pre-dose and post-dose.
Pre-dose and post-dose on Day 1 of Cycles 1 and 2; 3-24 hours post-dose on Cycle 1 Day 1 only (up to approximately 7 weeks)
Objective Response Rate (ORR)
Tidsramme: From baseline; assessed by BICR per RECIST 1.1/PCWG3 every 8 weeks for first 32 weeks, then every 12 weeks until radiographic progression (up to approximately 33 months)
ORR is defined as the proportion of participants with measurable soft tissue disease at baseline who have a CR or PR as determined by BICR, per RECIST 1.1 (soft tissue) and PCWG3 criteria (bone).
From baseline; assessed by BICR per RECIST 1.1/PCWG3 every 8 weeks for first 32 weeks, then every 12 weeks until radiographic progression (up to approximately 33 months)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. mai 2026

Primær fullføring (Antatt)

4. juni 2029

Studiet fullført (Antatt)

6. juni 2030

Datoer for studieregistrering

Først innsendt

22. april 2026

Først innsendt som oppfylte QC-kriteriene

20. mai 2026

Først lagt ut (Faktiske)

28. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D9735C00001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingstidsramme

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tilgangskriterier for IPD-deling

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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