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

25 августа 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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).

Тип исследования

Интервенционный

Регистрация (Оцененный)

152

Фаза

  • Фаза 2
  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

  • Австралия
      • North Adelaide, Австралия, 5000
        • Еще не набирают
        • Research Site
  • Германия
      • Essen, Германия, 45147
        • Еще не набирают
        • Research Site
      • Jena, Германия, 07747
        • Еще не набирают
        • Research Site
      • Rostock, Германия, 18057
        • Еще не набирают
        • Research Site
      • Tübingen, Германия, 72076
        • Еще не набирают
        • Research Site
  • Испания
      • Barcelona, Испания, 08028
        • Еще не набирают
        • Research Site
      • L'Hospitalet de Llobregat, Испания, 08908
        • Еще не набирают
        • Research Site
      • Madrid, Испания, 28041
        • Еще не набирают
        • Research Site
      • Madrid, Испания, 28031
        • Еще не набирают
        • Research Site
      • Pamplona, Испания, 31008
        • Еще не набирают
        • Research Site
  • Италия
      • Bergamo, Италия, 24127
        • Еще не набирают
        • Research Site
      • Meldola, Италия, 47014
        • Еще не набирают
        • Research Site
      • Milan, Италия, 20141
        • Еще не набирают
        • Research Site
      • Milan, Италия, 20133
        • Еще не набирают
        • Research Site
      • Roma, Италия, 00168
        • Еще не набирают
        • Research Site
  • Соединенное Королевство
      • Belfast, Соединенное Королевство, BT9 7AB
        • Еще не набирают
        • Research Site
      • Fulham, Соединенное Королевство, SW3 6JJ
        • Еще не набирают
        • Research Site
      • Guildford, Соединенное Королевство, CU2 7XX
        • Еще не набирают
        • Research Site
      • London, Соединенное Королевство, WC1E 6DB
        • Еще не набирают
        • Research Site
      • Newcastle upon Tyne, Соединенное Королевство, NE7 7DN
        • Еще не набирают
        • Research Site
      • Oxford, Соединенное Королевство, OX3 7LE
        • Еще не набирают
        • Research Site
  • Соединенные Штаты
    • California
      • Duarte, California, Соединенные Штаты, 91010
        • Еще не набирают
        • Research Site
      • Encino, California, Соединенные Штаты, 91436
        • Еще не набирают
        • Research Site
      • South Pasadena, California, Соединенные Штаты, 91030
        • Рекрутинг
        • Research Site
    • Florida
      • Miami, Florida, Соединенные Штаты, 33165
        • Рекрутинг
        • Research Site
      • Tampa, Florida, Соединенные Штаты, 33612
        • Еще не набирают
        • Research Site
    • Louisiana
      • Metairie, Louisiana, Соединенные Штаты, 70006
        • Еще не набирают
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, Соединенные Штаты, 55455
        • Еще не набирают
        • Research Site
    • Nebraska
      • Omaha, Nebraska, Соединенные Штаты, 68130
        • Еще не набирают
        • Research Site
    • New York
      • New York, New York, Соединенные Штаты, 10065
        • Еще не набирают
        • Research Site
    • Oregon
      • Portland, Oregon, Соединенные Штаты, 97239
        • Еще не набирают
        • Research Site
    • Texas
      • Houston, Texas, Соединенные Штаты, 77030
        • Еще не набирают
        • Research Site
  • Южная Корея
      • Seoul, Южная Корея, 03080
        • Еще не набирают
        • Research Site
      • Seoul, Южная Корея, 03722
        • Еще не набирают
        • Research Site
      • Seoul, Южная Корея, 06591
        • Еще не набирают
        • Research Site
      • Seoul, Южная Корея, 06351
        • Еще не набирают
        • Research Site
      • Seoul, Южная Корея, 5505
        • Отозван
        • Research Site

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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).

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Последовательное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: SS1B: AZD2265 (FPI-2265) monotherapy
Participants will receive AZD2265 (FPI-2265) monotherapy Q6W.
Лекарство: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Другие имена:
  • FPI-2265
  • 225Ac-PSMA-I&T
Лекарство: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Активный компаратор: SS1B: Docetaxel
Participants will receive docetaxel as a standard of care (SoC) once every 3 weeks (Q3W).
Лекарство: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Лекарство: Docetaxel
Docetaxel will be administered as an IV infusion.
Экспериментальный: 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).
Лекарство: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Другие имена:
  • FPI-2265
  • 225Ac-PSMA-I&T
Лекарство: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Лекарство: Palacaparib (AZD9574)
Palacaparib (AZD9574) will be administered orally.
Экспериментальный: 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.
Лекарство: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Другие имена:
  • FPI-2265
  • 225Ac-PSMA-I&T
Лекарство: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Лекарство: Palacaparib (AZD9574)
Palacaparib (AZD9574) will be administered orally.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Part A and Part B: Change from baseline in study-specific biomarker XYZ in response to treatment
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

AstraZeneca

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

3 июня 2026 г.

Первичное завершение (Оцененный)

25 сентября 2029 г.

Завершение исследования (Оцененный)

25 сентября 2029 г.

Даты регистрации исследования

Первый отправленный

11 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

11 мая 2026 г.

Первый опубликованный (Действительный)

15 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

27 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

25 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • D7642C00001
  • 2025 (Грант/контракт NIH США: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524920-23 (Другой идентификатор: EU CT number)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана 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.

Сроки обмена 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.

Критерии совместного доступа к 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.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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