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進行性固形悪性腫瘍患者における単剤療法および抗がん剤との併用療法としてのAZD5305の研究 (PETRA)

2026年9月18日 更新者：AstraZeneca

進行性固形悪性腫瘍患者における単剤療法および抗がん剤との併用療法としての AZD5305 の漸増用量の安全性、忍容性、薬物動態、薬力学および予備的有効性を評価するためのモジュラー第 I/IIa 相非盲検多施設試験

This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

This study is a Phase I/IIa modular, open-label, multi-center study of AZD5305 administered orally, either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies.

研究の種類

介入

入学 (実際)

702

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。

研究場所

  • アメリカ
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Research Site
      • Boston、Massachusetts、アメリカ、02215
        • Research Site
    • New York
      • New York、New York、アメリカ、10021
        • Research Site
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73104
        • Research Site
    • Texas
      • Houston、Texas、アメリカ、77030
        • Research Site
  • イギリス
      • Cambridge、イギリス、CB2 0QQ
        • Research Site
      • Manchester、イギリス、M20 4BX
        • Research Site
      • Oxford、イギリス、OX3 7LE
        • Research Site
      • Sutton、イギリス、SM2 5PT
        • Research Site
  • イタリア
      • Milan、イタリア、20141
        • Research Site
      • Milan、イタリア、20132
        • Research Site
      • Modena、イタリア、41125
        • Research Site
      • Naples、イタリア、80131
        • Research Site
      • Padova、イタリア、35128
        • Research Site
      • Roma、イタリア、00168
        • Research Site
  • ウクライナ
      • Chernivtsі、ウクライナ、58013
        • Research Site
      • Ivano-Frankivsk、ウクライナ、76018
        • Research Site
      • Kyiv、ウクライナ、03022
        • Research Site
      • Uzhhorod、ウクライナ、88000
        • Research Site
  • オーストラリア
      • Heidelberg、オーストラリア、3084
        • Research Site
      • Melbourne、オーストラリア、3000
        • Research Site
  • カナダ
    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 1K1
        • Research Site
    • Ontario
      • Toronto、Ontario、カナダ、M5G 2M9
        • Research Site
    • Quebec
      • Montreal、Quebec、カナダ、H3T 1E2
        • Research Site
      • Montreal、Quebec、カナダ、H2X 0A9
        • Research Site
  • スペイン
      • Barcelona、スペイン、08035
        • Research Site
      • Madrid、スペイン、28041
        • Research Site
      • Madrid、スペイン、28040
        • Research Site
      • Madrid、スペイン、28050
        • Research Site
      • Málaga、スペイン、29010
        • Research Site
      • Pozuelo de Alarcón、スペイン、28223
        • Research Site
      • Seville、スペイン、41013
        • Research Site
  • チェコ
      • Brno、チェコ、656 53
        • Research Site
      • Prague、チェコ、15006
        • Research Site
  • ハンガリー
      • Budapest、ハンガリー、1122
        • Research Site
      • Budapest、ハンガリー、1062
        • Research Site
      • Budapest、ハンガリー、1082
        • Research Site
  • ポーランド
      • Bydgoszcz、ポーランド、85-796
        • Research Site
      • Gdansk、ポーランド、80-214
        • Research Site
      • Gdynia、ポーランド、81-519
        • Research Site
      • Grzepnica、ポーランド、72-003
        • Research Site
      • Lodz、ポーランド、90-302
        • Research Site
      • Torun、ポーランド、87-100
        • Research Site
      • Warsaw、ポーランド、02-781
        • Research Site
  • ロシア
      • Moscow、ロシア、115478
        • Research Site
      • Moscow、ロシア、117997
        • Research Site
      • Moscow、ロシア、111123
        • Research Site
      • Moscow、ロシア、143442
        • Research Site
  • 中国
      • Beijing、中国、100142
        • Research Site
      • Changchun、中国、130021
        • Research Site
      • Changsha、中国、410013
        • Research Site
      • Chengdu、中国、610041
        • Research Site
      • Chongqing、中国、400030
        • Research Site
      • Guangzhou、中国、510060
        • Research Site
      • Harbin、中国、150081
        • Research Site
      • Jining、中国、272029
        • Research Site
      • Shandong、中国
        • Research Site
      • Shanghai、中国、200032
        • Research Site
      • Shanghai、中国、200025
        • Research Site
      • Taiyuan、中国、030001
        • Research Site
      • Wuhan、中国、430079
        • Research Site
      • Xi'an、中国、710061
        • Research Site
  • 日本
      • Chūōku、日本、104-0045
        • Research Site
      • Kōtoku、日本、135-8550
        • Research Site
  • 韓国
      • Seoul、韓国、03080
        • Research Site
      • Seoul、韓国、03722
        • Research Site
      • Seoul、韓国、05505
        • Research Site
      • Seoul、韓国、06351
        • 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

18年～130年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Key Inclusion Criteria:

  • Age ≥ 18 at the time of screening
  • Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria..
  • Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
  • Life expectancy ≥ 12 weeks
  • Progressive cancer at the time of study entry
  • Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B
  • Adequate organ and marrow function as defined by the protocol.
  • For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.

For Part A:

- Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)

For Part B:

- Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).

Key Exclusion Criteria:

  • Treatment with any of the following:

    1. Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
    2. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study treatment
    3. Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
    4. Any live virus or bacterial vaccine within 28 days of the first dose of study treatment

  • Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong inhibitors or inducers.

  • Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.

  • Receiving continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent for any reason.

  • Major surgery within 4 weeks of the first dose of study treatment.

  • Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.

  • Any history of persisting (> 2 weeks) severe pancytopenia due to any cause

  • Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of >10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.

  • patient with known predisposition to bleeding (e.g., active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).

  • Cardiac conditions as defined by the clinical study protocol

  • Other cardiovascular diseases as defined by any of the following:

    1. Symptomatic heart failure,
    2. uncontrolled hypertension,
    3. hypertensive heart disease with significant left ventricular hypertrophy
    4. acute coronary syndrome (ACS)/acute myocardial infarction (AMI), unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months.
    5. cardiomyopathy of any etiology
    6. presence of clinically significant valvular heart disease
    7. history of atrial or ventricular arrhythmia requiring treatment; subjects with atrial fibrillation and optimally controlled ventricular rate (< 100 beats per minute) are permitted.
    8. subjects with atrial fibrillation and optimally controlled ventricular rate are permitted
    9. transient ischaemic attack, or stroke within 6 months prior to screening
    10. patients with symptomatic hypotension at screening

  • Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).

  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305

  • Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).

Prior malignancy whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.

other module-specific criteria may apply

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：非ランダム化
  • 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：Module 1: AZD5305 Monotherapy

AZD5305 Monotherapy
薬：AZD5305

Oral PARP inhibitor
実験的：Module 2: AZD5305 + Paclitaxel

AZD5305 + Paclitaxel
薬：AZD5305

Oral PARP inhibitor

薬：Paclitaxel

IV Anti-microtubule agent
実験的：Module 3: AZD5305 + Carboplatin with or without Paclitaxel

AZD5305 + Carboplatin with or without Paclitaxel
薬：AZD5305

Oral PARP inhibitor

薬：Paclitaxel

IV Anti-microtubule agent

薬：Carboplatin

IV Platinum chemotherapeutic
実験的：Module 4: AZD5305 + Trastuzumab Deruxtecan

AZD5305 + T- DXd
薬：AZD5305

Oral PARP inhibitor

薬：T- Dxd

IV Antibody-drug conjugate
実験的：Module 5 AZD5305 + Datopotamab Deruxtecan

AZD5305 + Dato-DXd
薬：AZD5305

Oral PARP inhibitor

薬：Dato-DXd

IV Antibody-drug conjugate
実験的：Module 6 AZD5305 + Camizestrant

AZD5305 + Camizestrant
薬：AZD5305

Oral PARP inhibitor

薬：Camizestrant

Oral SERD Molecule

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
The number of subjects with adverse events/serious adverse events
時間枠：From time of Informed Consent to 28 + 7 days post last dose ( modules 1,2,3,5 and 6). 40+7 days post last dose for Module 4.

Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline
From time of Informed Consent to 28 + 7 days post last dose ( modules 1,2,3,5 and 6). 40+7 days post last dose for Module 4.
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.
時間枠：From first dose of study treatment until the end of Cycle 1.

A DLT is defined as any toxicity that occurs from the first dose of study treatment (either AZD5305 or combination anti-cancer agent) up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation. DLTs occurring outside the DLT window (ie, late onset toxicities) may be defined as a DLT after consultation with the sponsor and investigators, based on the emerging safety profile.
From first dose of study treatment until the end of Cycle 1.

二次結果の測定

結果測定
メジャーの説明
時間枠
Best percentage change in target lesion
時間枠：From Screening to confirmed progressive disease (approximately 1 year)

Change in target lesion size from baseline, as defined by RECIST 1.1.
From Screening to confirmed progressive disease (approximately 1 year)
Objective Response Rate
時間枠：From Screening to confirmed progressive disease (approximately 1 year)

Best response until progression, as defined by RECIST 1.1.
From Screening to confirmed progressive disease (approximately 1 year)
Duration of Response
時間枠：From Screening to confirmed progressive disease (approximately 1 year)

Time from first response to progression or death , as defined by RECIST 1.1.
From Screening to confirmed progressive disease (approximately 1 year)
Progression Free Survival
時間枠：From Screening to confirmed progressive disease (approximately 1 year)

Time from C1D1 to progression or death, as defined by RECIST 1.1.
From Screening to confirmed progressive disease (approximately 1 year)
Time To Response
時間枠：From Screening to confirmed progressive disease (approximately 1 year)

Time from C1D1 to complete or partial response, as defined by RECIST 1.1.
From Screening to confirmed progressive disease (approximately 1 year)
Effects of AZD5305 on pH2AX (Ser139) PD biomarker
時間枠：From Cycle 0 Day 1 to Cycle 1 Day 15 (approximately 21 days)

Measure change from baseline in pH2AX
From Cycle 0 Day 1 to Cycle 1 Day 15 (approximately 21 days)
CA125 response (ovarian cancer)
時間枠：From Screening to confirmed progressive disease (approximately 1 year)

at least a 50% reduction in CA125 levels from a pre-treatment sample as defined by GCIG criteria.
From Screening to confirmed progressive disease (approximately 1 year)
Module 1: Area Under Curve (AUC)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 1: Maximum plasma concentration of the drug (Cmax)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 1: The time taken to reach the maximum concentration (Tmax)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 1 and Module 5: Objective Response Rate (prostate cancer)
時間枠：From Screening to confirmed progressive disease (approximately 1 year)

Best response until progression, as defined by RECIST 1.1 or PCWG3 (bone)
From Screening to confirmed progressive disease (approximately 1 year)
Module 1: Radiographic progression free survival (prostate cancer)
時間枠：From Screening to confirmed progressive disease (approximately 1 year)

Time from C1D1 to progression or death, as defined by RECIST 1.1 and PCWG3(bone).
From Screening to confirmed progressive disease (approximately 1 year)
Module 1: Proportion of subjects with ≥ 50% PSA decrease (prostate cancer)
時間枠：From Screening to confirmed progressive disease (approximately 1 year)

PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment
From Screening to confirmed progressive disease (approximately 1 year)
Module 1 : To investigate the effect of a high-fat meal on the PK of AZD5305
時間枠：Cycle 0, Day 1 (C0D1), in either the "fasted" or "fed" state, followed by a single oral dose of AZD5305 in the other state for Cycle 1, Day 1 (C1D1) at least 72 hours later; 1 cycle is 28 days.

Effect on High fat meal on PK parameters of AZD5305.PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without food
Cycle 0, Day 1 (C0D1), in either the "fasted" or "fed" state, followed by a single oral dose of AZD5305 in the other state for Cycle 1, Day 1 (C1D1) at least 72 hours later; 1 cycle is 28 days.
Module 2: Area Under Curve (AUC)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 2: Maximum plasma concentration of the drug (Cmax)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 2: The time taken to reach the maximum concentration (Tmax)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 3: Area Under Curve (AUC)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 3: Maximum plasma concentration of the drug (Cmax)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 3: The time taken to reach the maximum concentration (Tmax)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4 : Area Under Curve
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4: Maximum plasma concentration of the drug (Cmax)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4: The time taken to reach the maximum concentration (Tmax)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4: Anti-Drug Antibody (ADA)
時間枠：Samples will be collected within 1 hour before dose administration on Day 1 of Cycle 1, 2, and 4, then every 4 Cycles (each cycle is 21 days), EoT, and at safety follow-up (40 days after last dose) as per Schedule of Assessments

To investigate the presence of ADAs for T-DXd
Samples will be collected within 1 hour before dose administration on Day 1 of Cycle 1, 2, and 4, then every 4 Cycles (each cycle is 21 days), EoT, and at safety follow-up (40 days after last dose) as per Schedule of Assessments
Module 4: To assess the preliminary anti-tumour activity of AZD5305 as monotherapy and in combination with T-DXd.
時間枠：From screening to approximately 6 months

Time from C1D1 to progression or death, as defined by RECIST v 1.1 summarised at the 6 month landmark (PFS6)
From screening to approximately 6 months
Module 5: Area Under Curve
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 5: Maximum plasma concentration of the drug (Cmax)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 5: The time taken to reach the maximum concentration (Tmax)
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 5: Anti-Drug Antibody (ADA)
時間枠：Whole blood samples for determination of ADA for Dato-DXd in plasma will be collected in patients receiving Dato-DXd per the schedule specified in the SoA : Day 1 of Cycle 1, 2, 4, and 8 (each cycle is 21 days) , EoT, and then 28 day follow up visit.

Presence of ADAs for Dato-DXd
Whole blood samples for determination of ADA for Dato-DXd in plasma will be collected in patients receiving Dato-DXd per the schedule specified in the SoA : Day 1 of Cycle 1, 2, 4, and 8 (each cycle is 21 days) , EoT, and then 28 day follow up visit.
Module 5: Premilinary anti tumour activity AZD5305 in combination with Dato-DXd
時間枠：From screening to confirmed progresive disease ( approximately 12 weeks)

objective response rate and radiographic progression-free survival using RECIST v1.1.

Proportion of patients achieving a ≥ 50% decrease in PSA from baseline to the post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later (PSA50 response).
From screening to confirmed progresive disease ( approximately 12 weeks)
Module 6: To characterise the PK of AZD5305 and camizestrant following a single dose and at steady state after multiple dosing, when given in combination.
時間枠：At predefined interval throughout the treatment (approximately 12 weeks)

Plasma concentrations and PK parameters of AZD5305 and camizestrant after single dose and multiple dose administration, including, but not limited to:

AUC, Cmax, Tmax, as data allow
At predefined interval throughout the treatment (approximately 12 weeks)
Module 6: To evaluate the effect of camizestrant on the PK of AZD5305.
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without camizestrant.
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 6: To evaluate the effect of AZD5305 on the PK of Camizestrant.
時間枠：At predefined intervals throughout the treatment period (approximately 12 weeks)

PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without AZD5305.
At predefined intervals throughout the treatment period (approximately 12 weeks)

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

捜査官

  • 主任研究者：Timothy Yap、M.D. Anderson Cancer Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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)

2020年11月12日

一次修了 (推定)

2027年5月28日

研究の完了 (推定)

2027年5月28日

試験登録日

最初に提出

2020年10月26日

QC基準を満たした最初の提出物

2020年11月19日

最初の投稿 (実際)

2020年11月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月21日

QC基準を満たした最後の更新が送信されました

2026年9月18日

最終確認日

2026年9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

  • D9720C00001
  • 2020-002688-77 (EudraCT番号)

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

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