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Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer (PROSPECTOR)

25 août 2026 mis à jour par: AstraZeneca

A Phase Ib/II, Open-label, Multi-centre, Platform Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Multiple Anti-Cancer Agents in Metastatic Prostate Cancer

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic prostate cancer.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a multicentre, open-label and platform study to evaluate multiple anti-cancer agents in participants with metastatic prostate cancer. This platform study will comprise a series of substudies. Each substudy will follow a 2-part structure (unless otherwise stated in the individual substudy):

  • Part A: A dose escalation (DE) phase to identify dose limiting toxicities (DLTs), characterise safety, PK, pharmacodynamics, preliminary efficacy, and determine biologically and clinically suitable dose levels to proceed into the dose optimisation/expansion.
  • Part B: A dose optimisation/expansion phase to inform recommended Phase 3 dose (RP3D), explore efficacy with Prostate-specific antigen (PSA) decrease ≥ 50% (PSA50) rate as primary endpoints, alongside continued safety monitoring.

Sub-study 1 focuses on a specific combination regimen and it will assess the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumour activity of AZD2265 (FPI-2265) actinium (225Ac) zadavotide guraxetan [hereafter referred to as AZD2265 (FPI-2265)] in combination with palacaparib (AZD9574) compared with AZD2265 (FPI-2265) monotherapy and with standard-of-care (SoC) docetaxel chemotherapy in participants with metastatic castration resistant prostate cancer (mCRPC).

Type d'étude

Interventionnel

Inscription (Estimé)

152

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Allemagne
      • Essen, Allemagne, 45147
        • Pas encore de recrutement
        • Research Site
      • Jena, Allemagne, 07747
        • Pas encore de recrutement
        • Research Site
      • Rostock, Allemagne, 18057
        • Pas encore de recrutement
        • Research Site
      • Tübingen, Allemagne, 72076
        • Pas encore de recrutement
        • Research Site
  • Australie
      • North Adelaide, Australie, 5000
        • Pas encore de recrutement
        • Research Site
  • Corée du Sud
      • Seoul, Corée du Sud, 03080
        • Pas encore de recrutement
        • Research Site
      • Seoul, Corée du Sud, 03722
        • Pas encore de recrutement
        • Research Site
      • Seoul, Corée du Sud, 06591
        • Pas encore de recrutement
        • Research Site
      • Seoul, Corée du Sud, 06351
        • Pas encore de recrutement
        • Research Site
      • Seoul, Corée du Sud, 5505
        • Retiré
        • Research Site
  • Espagne
      • Barcelona, Espagne, 08028
        • Pas encore de recrutement
        • Research Site
      • L'Hospitalet de Llobregat, Espagne, 08908
        • Pas encore de recrutement
        • Research Site
      • Madrid, Espagne, 28041
        • Pas encore de recrutement
        • Research Site
      • Madrid, Espagne, 28031
        • Pas encore de recrutement
        • Research Site
      • Pamplona, Espagne, 31008
        • Pas encore de recrutement
        • Research Site
  • Italie
      • Bergamo, Italie, 24127
        • Pas encore de recrutement
        • Research Site
      • Meldola, Italie, 47014
        • Pas encore de recrutement
        • Research Site
      • Milan, Italie, 20141
        • Pas encore de recrutement
        • Research Site
      • Milan, Italie, 20133
        • Pas encore de recrutement
        • Research Site
      • Roma, Italie, 00168
        • Pas encore de recrutement
        • Research Site
  • Royaume-Uni
      • Belfast, Royaume-Uni, BT9 7AB
        • Pas encore de recrutement
        • Research Site
      • Fulham, Royaume-Uni, SW3 6JJ
        • Pas encore de recrutement
        • Research Site
      • Guildford, Royaume-Uni, CU2 7XX
        • Pas encore de recrutement
        • Research Site
      • London, Royaume-Uni, WC1E 6DB
        • Pas encore de recrutement
        • Research Site
      • Newcastle upon Tyne, Royaume-Uni, NE7 7DN
        • Pas encore de recrutement
        • Research Site
      • Oxford, Royaume-Uni, OX3 7LE
        • Pas encore de recrutement
        • Research Site
  • États-Unis
    • California
      • Duarte, California, États-Unis, 91010
        • Pas encore de recrutement
        • Research Site
      • Encino, California, États-Unis, 91436
        • Pas encore de recrutement
        • Research Site
      • South Pasadena, California, États-Unis, 91030
        • Recrutement
        • Research Site
    • Florida
      • Miami, Florida, États-Unis, 33165
        • Recrutement
        • Research Site
      • Tampa, Florida, États-Unis, 33612
        • Pas encore de recrutement
        • Research Site
    • Louisiana
      • Metairie, Louisiana, États-Unis, 70006
        • Pas encore de recrutement
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, États-Unis, 55455
        • Pas encore de recrutement
        • Research Site
    • Nebraska
      • Omaha, Nebraska, États-Unis, 68130
        • Pas encore de recrutement
        • Research Site
    • New York
      • New York, New York, États-Unis, 10065
        • Pas encore de recrutement
        • Research Site
    • Oregon
      • Portland, Oregon, États-Unis, 97239
        • Pas encore de recrutement
        • Research Site
    • Texas
      • Houston, Texas, États-Unis, 77030
        • Pas encore de recrutement
        • Research Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell).
  2. Minimum life expectancy of 3 months or more.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration.
  4. PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease.
  5. Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate.
  6. Must have one or more unresectable metastatic lesions.
  7. Must have had prior orchiectomy and/or ongoing androgen deprivation therapy, and a castrate level of serum testosterone (<50ng/dL or <l.7nmol/L).
  8. Progressive metastatic castration-resistant prostate cancer (mCRPC) following the most recent treatment at time of study entry.
  9. Adequate organ and marrow function.
  10. Non sterilised participants who are sexually active with a partner of childbearing potential must use a condom (plus spermicide, if available), must refrain from fathering a child, freezing or donating sperm, and it is recommended for the partner to also use a highly effective contraceptive method.

Inclusion Criteria for Sub study 1:

  1. Must have received a single line of ARPI, such as enzalutamide, darolutamide, apalutamide or abiraterone acetate. Participants who were exposed to more than one ARPI due to toxicity or intolerance (not due to disease progression) are eligible.
  2. PSMA positive mCRPC by computed tomography positron emission tomography, obtained with PSMA ligand defined as at least 1 PSMA positive metastatic lesion with tracer uptake greater than liver, and no PSMA negative lesions. All measurable or intraprostatic lesions must be PSMA positive.
  3. Capable of self-administering oral formulations.

Exclusion Criteria:

  1. Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous).
  2. Known, unresolved urinary tract obstruction.
  3. Participants with a history of central nervous system metastases.
  4. Symptomatic malignant spinal cord compression or findings indicative of impending cord compression.
  5. Participants with a history of leptomeningeal carcinomatosis.
  6. Previous or concurrent cancer distinct from the cancer under investigation in primary site or histology .
  7. Concurrent serious medical conditions.
  8. Previous history of interstitial lung disease or non-infectious pneumonitis.
  9. Participants with a history or clinical/laboratory features suggestive of myelodysplastic syndrome or acute myeloid leukaemia.
  10. Persistent toxicities caused by previous therapy.
  11. Participants unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with absorption.
  12. Active infection, including tuberculosis, hepatitis C virus, and hepatitis B virus infection.
  13. Known hypersensitivity to study intervention or any of their excipients.

Exclusion Criteria for Sub study 1:

  1. History of uncontrolled seizures or requirement for >2 antiepileptic drugs.
  2. History of severe brain injury or stroke.
  3. Skeletal metastases demonstrating a superscan appearance on bone scan.
  4. Participants have received prior therapy with palacaparib (AZD9574) or more than 1 prior line of any other Poly-ADP-ribose polymerase inhibitor (PARPi)-based regimen (either as a treatment or as maintenance).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: SS1B: AZD2265 (FPI-2265) monotherapy
Participants will receive AZD2265 (FPI-2265) monotherapy Q6W.
Médicament: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Autres noms:
  • FPI-2265
  • 225Ac-PSMA-I&T
Médicament: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Comparateur actif: SS1B: Docetaxel
Participants will receive docetaxel as a standard of care (SoC) once every 3 weeks (Q3W).
Médicament: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Médicament: Docetaxel
Docetaxel will be administered as an IV infusion.
Expérimental: Substudy 1 Part A(SS1A): escalating dose levels of palacaparib in combination with AZD2265(FPI-2265)
Participants will receive escalating dose levels of palacaparib (AZD9574) once daily in combination with AZD2265 (FPI-2265) once every 6 weeks (Q6W).
Médicament: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Autres noms:
  • FPI-2265
  • 225Ac-PSMA-I&T
Médicament: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Médicament: Palacaparib (AZD9574)
Palacaparib (AZD9574) will be administered orally.
Expérimental: Sub study 1 Part B(SS1B): selected dose of palacaparib in combination with AZD2265(FPI-2265)
Participants will receive palacaparib (AZD9574) chosen from the DE phase once daily in combination with AZD2265 (FPI-2265) Q6W.
Médicament: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Autres noms:
  • FPI-2265
  • 225Ac-PSMA-I&T
Médicament: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Médicament: Palacaparib (AZD9574)
Palacaparib (AZD9574) will be administered orally.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Part A: Number of participants with treatment-emergent adverse events (TEAEs)including serious adverse events (SAEs), treatment-related AEs (TRAEs) and adverse events of special interests (AESIs)
Délai: Up to approximately 1 year after last dose
To assess the safety and tolerability of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
Up to approximately 1 year after last dose
Part A: Number of participants with dose limiting toxicities (DLTs)
Délai: From date of first dose up to approximately 2 cycles (up to 3 months)
To assess the safety and tolerability, and characterise the DLTs of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
From date of first dose up to approximately 2 cycles (up to 3 months)
Part B: Number of participants with TEAEs
Délai: Up to approximately 1 year after last dose
To further assess the safety and tolerability, and determine the recommended Phase 3 dose (RP3D) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
Up to approximately 1 year after last dose
Part B: Prostate Specific Antigen 50 (PSA50) response rate
Délai: Up to 3 years 4 months
PSA50 response rate is defined as proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later, and occurring prior to confirmed PSA progression. PSA50 will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Part A and Part B: Change from baseline in study-specific biomarker XYZ in response to treatment
Délai: Up to 3 years 4 months
To investigate study-specific XYZ expression and relationship to response to the treatment.
Up to 3 years 4 months
Part A and Part B: PSA50 response rate
Délai: Up to 3 years 4 months
PSA50 response rate is defined as proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later, and occurring prior to confirmed PSA progression. PSA50 will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B).
Up to 3 years 4 months
Part A and Part B: Prostate Specific Antigen 90 (PSA90) response rate
Délai: Up to 3 years 4 months
PSA90 response rate is defined as proportion of participants achieving a ≥ 90% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later, and occurring prior to confirmed PSA progression. PSA90 will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
Up to 3 years 4 months
Part A and Part B: Time to PSA50 (TTPSA50) response
Délai: Up to 3 years 4 months
TTPSA50 response is defined as the time from date of randomisation/first dose of study intervention until the date of first documented PSA50 response (≥ 50% decrease in PSA from baseline), confirmed by a second consecutive PSA assessment at least 3 weeks later. TTPSA50 response will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: Time to PSA90 (TTPSA90) response
Délai: Up to 3 years 4 months
TTPSA90 response is defined as the time from date of randomisation/first dose of study intervention until the date of first documented PSA90 response (≥ 90% decrease in PSA from baseline, respectively), confirmed by a second consecutive PSA assessment at least 3 weeks later. TTPSA90 response will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: Duration of PSA50 (DoPSA50) response
Délai: Up to 3 years 4 months
DoPSA50 response is defined as the time from the date of first documented PSA50 response, that is subsequently confirmed by a second consecutive PSA assessment at least 3 weeks later, until the date of documented PSA progression. DoPSA50 response will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: Duration of PSA90 (DoPSA90) response
Délai: Up to 3 years 4 months
DoPSA90 response is defined as the time from the date of first documented PSA90 response, that is subsequently confirmed by a second consecutive PSA assessment at least 3 weeks later, until the date of documented PSA progression. DoPSA90 response will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: Time to PSA progression
Délai: Up to 3 years 4 months
TTPSA progression is defined as time from the date of randomisation/first dose of study intervention until the date of documented PSA progression or the last PSA result in the absence of progression. PSA progression is defined as an increase in PSA of ≥ 25% from the nadir and an absolute increase of at least 2 ng/mL above nadir beyond 12 weeks. PSA progression must be confirmed by a second value taken at least 3 weeks later. TTPSA progression will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: PSA over time
Délai: Up to 3 years 4 months
PSA over time is defined as the longitudinal change in serum PSA from baseline across all on-study timepoints. PSA over time will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: Radiographic Progression-free survival (rPFS)
Délai: From Day 1 to 3 years 4 months
rPFS is defined as the time from date of randomisation/first dose of study intervention until the date of objective disease progression according to response evaluation criteria in solid tumors (RECIST) 1.1 (for soft tissue disease) and prostate cancer working group 3 (PCWG3) criteria (for bone disease) as assessed by the investigator at the local site, or death (by any cause in the absence of progression), regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy prior to progression. rPFS will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
From Day 1 to 3 years 4 months
Part A and Part B: Overall Response Rate (ORR)
Délai: From Day 1 to 3 years 4 months
The ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as the time from the date of first documented objective response (which is subsequently confirmed) until the date of radiographic disease progression or censored according to rules for rPFS. The ORR will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
From Day 1 to 3 years 4 months
Part A and Part B: Best Overall Response (BOR)
Délai: From Day 1 to 3 years 4 months
The BOR is defined as the best overall visit response the participant achieves as determined by the investigator at the local site. The BOR will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
From Day 1 to 3 years 4 months
Part A and Part B: Duration of response (DoR)
Délai: From Day 1 to 3 years 4 months
The DoR is defined based on RECIST 1.1 (for soft tissue disease) and PCWG3 criteria (for bone disease) as the time from the date of first documented objective response (which is subsequently confirmed) until date of radiographic disease progression or censored according to rules for rPFS. The DoR will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
From Day 1 to 3 years 4 months
Part A and Part B: Time to Response (TTR)
Délai: From Day 1 to 3 years 4 months
The TTR is defined as the time from the date of randomisation/first dose of study intervention until the date of first documented objective response, which is subsequently confirmed. The TTR will be assessed to check the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
From Day 1 to 3 years 4 months
Part A: Disease control rate (DCR)
Délai: From Day 1 to 3 years 4 months
To assess the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265)
From Day 1 to 3 years 4 months
Part A and Part B: Percentage change in tumour size
Délai: From Day 1 to 3 years 4 months
To assess the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
From Day 1 to 3 years 4 months
Part A and Part B: Plasma concentration of palacaparib (AZD9574)
Délai: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
To determine the PK of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
Part A and Part B: Plasma concentration of AZD2265 (FPI-2265)
Délai: From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle will be 42 days)
To determine the PK of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle will be 42 days)
Part A and Part B: Area under the concentration time curve (AUC)
Délai: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
To determine the PK (AUC) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
Part A and Part B: Maximum observed drug concentration (Cmax)
Délai: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
To determine the PK (Cmax) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
Part A and Part B: Time to reach Cmax (tmax)
Délai: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
To determine the PK (tmax) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
Part A and Part B: Terminal elimination half-life (t½λz)
Délai: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
To determine the PK (t½λz) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
Part A and Part B: Change from baseline in study-specific biomarker ABC in response to treatment
Délai: Up to 3 years 4 months
To investigate pharmacodynamics of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (for Part A and Part B) and of AZD2265 (FPI-2265) monotherapy (for Part B only).
Up to 3 years 4 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AstraZeneca

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

3 juin 2026

Achèvement primaire (Estimé)

25 septembre 2029

Achèvement de l'étude (Estimé)

25 septembre 2029

Dates d'inscription aux études

Première soumission

11 mai 2026

Première soumission répondant aux critères de contrôle qualité

11 mai 2026

Première publication (Réel)

15 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • D7642C00001
  • 2025 (Subvention/contrat des NIH des États-Unis: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524920-23 (Autre identifiant: EU CT number)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Délai de partage IPD

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

Critères d'accès au partage IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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