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

2026年8月25日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (推定)

152

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Duarte、California、アメリカ、91010
        • まだ募集していません
        • Research Site
      • Encino、California、アメリカ、91436
        • まだ募集していません
        • Research Site
      • South Pasadena、California、アメリカ、91030
        • 募集
        • Research Site
    • Florida
      • Miami、Florida、アメリカ、33165
        • 募集
        • Research Site
      • Tampa、Florida、アメリカ、33612
        • まだ募集していません
        • Research Site
    • Louisiana
      • Metairie、Louisiana、アメリカ、70006
        • まだ募集していません
        • Research Site
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55455
        • まだ募集していません
        • Research Site
    • Nebraska
      • Omaha、Nebraska、アメリカ、68130
        • まだ募集していません
        • Research Site
    • New York
      • New York、New York、アメリカ、10065
        • まだ募集していません
        • Research Site
    • Oregon
      • Portland、Oregon、アメリカ、97239
        • まだ募集していません
        • Research Site
    • Texas
      • Houston、Texas、アメリカ、77030
        • まだ募集していません
        • Research Site
  • イギリス
      • Belfast、イギリス、BT9 7AB
        • まだ募集していません
        • Research Site
      • Fulham、イギリス、SW3 6JJ
        • まだ募集していません
        • Research Site
      • Guildford、イギリス、CU2 7XX
        • まだ募集していません
        • Research Site
      • London、イギリス、WC1E 6DB
        • まだ募集していません
        • Research Site
      • Newcastle upon Tyne、イギリス、NE7 7DN
        • まだ募集していません
        • Research Site
      • Oxford、イギリス、OX3 7LE
        • まだ募集していません
        • Research Site
  • イタリア
      • Bergamo、イタリア、24127
        • まだ募集していません
        • Research Site
      • Meldola、イタリア、47014
        • まだ募集していません
        • Research Site
      • Milan、イタリア、20141
        • まだ募集していません
        • Research Site
      • Milan、イタリア、20133
        • まだ募集していません
        • Research Site
      • Roma、イタリア、00168
        • まだ募集していません
        • Research Site
  • オーストラリア
      • North Adelaide、オーストラリア、5000
        • まだ募集していません
        • Research Site
  • スペイン
      • Barcelona、スペイン、08028
        • まだ募集していません
        • Research Site
      • L'Hospitalet de Llobregat、スペイン、08908
        • まだ募集していません
        • Research Site
      • Madrid、スペイン、28041
        • まだ募集していません
        • Research Site
      • Madrid、スペイン、28031
        • まだ募集していません
        • Research Site
      • Pamplona、スペイン、31008
        • まだ募集していません
        • Research Site
  • ドイツ
      • Essen、ドイツ、45147
        • まだ募集していません
        • Research Site
      • Jena、ドイツ、07747
        • まだ募集していません
        • Research Site
      • Rostock、ドイツ、18057
        • まだ募集していません
        • Research Site
      • Tübingen、ドイツ、72076
        • まだ募集していません
        • Research Site
  • 韓国
      • Seoul、韓国、03080
        • まだ募集していません
        • Research Site
      • Seoul、韓国、03722
        • まだ募集していません
        • Research Site
      • Seoul、韓国、06591
        • まだ募集していません
        • Research Site
      • Seoul、韓国、06351
        • まだ募集していません
        • Research Site
      • Seoul、韓国、5505
        • 引きこもった
        • Research Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：順次割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：SS1B: AZD2265 (FPI-2265) monotherapy
Participants will receive AZD2265 (FPI-2265) monotherapy Q6W.
薬：AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
他の名前：
  • FPI-2265
  • 225Ac-PSMA-I&T
薬：AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
アクティブコンパレータ：SS1B: Docetaxel
Participants will receive docetaxel as a standard of care (SoC) once every 3 weeks (Q3W).
薬：AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
薬：Docetaxel
Docetaxel will be administered as an IV infusion.
実験的：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).
薬：AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
他の名前：
  • FPI-2265
  • 225Ac-PSMA-I&T
薬：AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
薬：Palacaparib (AZD9574)
Palacaparib (AZD9574) will be administered orally.
実験的：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.
薬：AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
他の名前：
  • FPI-2265
  • 225Ac-PSMA-I&T
薬：AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
薬：Palacaparib (AZD9574)
Palacaparib (AZD9574) will be administered orally.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Part A and Part B: Change from baseline in study-specific biomarker XYZ in response to treatment
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AstraZeneca

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月3日

一次修了 (推定)

2029年9月25日

研究の完了 (推定)

2029年9月25日

試験登録日

最初に提出

2026年5月11日

QC基準を満たした最初の提出物

2026年5月11日

最初の投稿 (実際)

2026年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月27日

QC基準を満たした最後の更新が送信されました

2026年8月25日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • D7642C00001
  • 2025 (米国 NIH グラント/契約：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524920-23 (その他の識別子：EU CT number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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