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

2026년 8월 25일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

152

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대한민국
      • Seoul, 대한민국, 03080
        • 아직 모집하지 않음
        • Research Site
      • Seoul, 대한민국, 03722
        • 아직 모집하지 않음
        • Research Site
      • Seoul, 대한민국, 06591
        • 아직 모집하지 않음
        • Research Site
      • Seoul, 대한민국, 06351
        • 아직 모집하지 않음
        • Research Site
      • Seoul, 대한민국, 5505
        • 빼는
        • Research Site
  • 독일
      • Essen, 독일, 45147
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        • Research Site
      • Jena, 독일, 07747
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        • Research Site
      • Rostock, 독일, 18057
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        • Research Site
      • Tübingen, 독일, 72076
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        • Research Site
  • 미국
    • California
      • Duarte, California, 미국, 91010
        • 아직 모집하지 않음
        • Research Site
      • Encino, California, 미국, 91436
        • 아직 모집하지 않음
        • Research Site
      • South Pasadena, California, 미국, 91030
        • 모병
        • Research Site
    • Florida
      • Miami, Florida, 미국, 33165
        • 모병
        • Research Site
      • Tampa, Florida, 미국, 33612
        • 아직 모집하지 않음
        • Research Site
    • Louisiana
      • Metairie, Louisiana, 미국, 70006
        • 아직 모집하지 않음
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55455
        • 아직 모집하지 않음
        • Research Site
    • Nebraska
      • Omaha, Nebraska, 미국, 68130
        • 아직 모집하지 않음
        • Research Site
    • New York
      • New York, New York, 미국, 10065
        • 아직 모집하지 않음
        • Research Site
    • Oregon
      • Portland, Oregon, 미국, 97239
        • 아직 모집하지 않음
        • Research Site
    • Texas
      • Houston, Texas, 미국, 77030
        • 아직 모집하지 않음
        • Research Site
  • 스페인
      • Barcelona, 스페인, 08028
        • 아직 모집하지 않음
        • Research Site
      • L'Hospitalet de Llobregat, 스페인, 08908
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        • Research Site
      • Madrid, 스페인, 28041
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        • Research Site
      • Madrid, 스페인, 28031
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        • Research Site
      • Pamplona, 스페인, 31008
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        • Research Site
  • 영국
      • Belfast, 영국, BT9 7AB
        • 아직 모집하지 않음
        • Research Site
      • Fulham, 영국, SW3 6JJ
        • 아직 모집하지 않음
        • Research Site
      • Guildford, 영국, CU2 7XX
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        • Research Site
      • London, 영국, WC1E 6DB
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        • Research Site
      • Newcastle upon Tyne, 영국, NE7 7DN
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        • Research Site
      • Oxford, 영국, OX3 7LE
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        • Research Site
  • 이탈리아
      • Bergamo, 이탈리아, 24127
        • 아직 모집하지 않음
        • Research Site
      • Meldola, 이탈리아, 47014
        • 아직 모집하지 않음
        • Research Site
      • Milan, 이탈리아, 20141
        • 아직 모집하지 않음
        • Research Site
      • Milan, 이탈리아, 20133
        • 아직 모집하지 않음
        • Research Site
      • Roma, 이탈리아, 00168
        • 아직 모집하지 않음
        • Research Site
  • 호주
      • North Adelaide, 호주, 5000
        • 아직 모집하지 않음
        • Research Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: SS1B: AZD2265 (FPI-2265) monotherapy
Participants will receive AZD2265 (FPI-2265) monotherapy Q6W.
의약품: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
다른 이름들:
  • FPI-2265
  • 225Ac-PSMA-I&T
의약품: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
활성 비교기: SS1B: Docetaxel
Participants will receive docetaxel as a standard of care (SoC) once every 3 weeks (Q3W).
의약품: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
의약품: Docetaxel
Docetaxel will be administered as an IV infusion.
실험적: 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).
의약품: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
다른 이름들:
  • FPI-2265
  • 225Ac-PSMA-I&T
의약품: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
의약품: Palacaparib (AZD9574)
Palacaparib (AZD9574) will be administered orally.
실험적: 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.
의약품: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
다른 이름들:
  • FPI-2265
  • 225Ac-PSMA-I&T
의약품: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
의약품: Palacaparib (AZD9574)
Palacaparib (AZD9574) will be administered orally.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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)
기간: 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)
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Part A and Part B: Change from baseline in study-specific biomarker XYZ in response to treatment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 3일

기본 완료 (추정된)

2029년 9월 25일

연구 완료 (추정된)

2029년 9월 25일

연구 등록 날짜

최초 제출

2026년 5월 11일

QC 기준을 충족하는 최초 제출

2026년 5월 11일

처음 게시됨 (실제)

2026년 5월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 25일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D7642C00001
  • 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524920-23 (기타 식별자: EU CT number)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

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.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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