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進行性固形腫瘍用 PRO1184 (RAINFOL-01)

2026年11月2日 更新者：Genmab

局所進行性および/または転移性固形腫瘍を有する患者におけるPRO1184の第1/2相試験

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.

Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a Phase 1/2 study of Rina-S; also known as GEN1184, formerly known as PRO1184, a folate receptor alpha (FRα) targeted antibody-drug conjugate, to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Rina-S in participants with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma.

The study consists of multiple parts:

Part A: monotherapy cohorts

Part B: tumor-specific monotherapy dose-expansion cohorts

Part C: platinum-resistant ovarian cancer (PROC) monotherapy cohort

Part D: combination therapy cohorts

Part E: a monotherapy PROC cohort

Parts F and G: a monotherapy endometrial cancer (EC) cohort

Part H: a monotherapy PROC cohort

Part I: platinum-sensitive ovarian cancer (PSOC) cohort

Part J: a monotherapy PROC cohort

Part K: a monotherapy high-grade ovarian cancer cohort

Part L: a drug-drug interaction substudy

Participants will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

研究の種類

介入

入学 (推定)

952

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
    • Arizona
      • Phoenix、Arizona、アメリカ、85016
        • 募集
        • USOR HonorHealth
      • Tucson、Arizona、アメリカ、85711
        • 募集
        • USOR Arizona Oncology Associates
    • California
      • Los Angeles、California、アメリカ、90095
        • 募集
        • University of California Los Angeles Medical Center
      • San Diego、California、アメリカ、92093
        • 募集
        • University of California, San Diego; Moores Cancer Center
      • Santa Barbara、California、アメリカ、93105
        • 募集
        • USOR Sansum Clinic
      • Santa Rosa、California、アメリカ、95403
        • 募集
        • Providence Medical Foundation
    • Florida
      • Fort Myers、Florida、アメリカ、33908
        • 募集
        • USOR Florida Cancer Specialists South
      • St. Petersburg、Florida、アメリカ、33709
        • 募集
        • USOR Florida Cancer Specialists North
      • West Palm Beach、Florida、アメリカ、33401
        • 募集
        • USOR Florida Cancer Specialists East
    • Georgia
      • Augusta、Georgia、アメリカ、30912
        • 募集
        • Augusta University Georgia Cancer Center
    • Kansas
      • Westwood、Kansas、アメリカ、66205
        • 募集
        • University of Kansas Medical Center (KUMC)
    • Maryland
      • Rockville、Maryland、アメリカ、20850
        • 募集
        • USOR Maryland Oncology Hematology
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • 募集
        • Massachusetts General Hospital
      • Boston、Massachusetts、アメリカ、02215
        • 募集
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit、Michigan、アメリカ、48085
        • 募集
        • Karmanos Cancer Institute
      • Grand Rapids、Michigan、アメリカ、49503
        • 募集
        • START Midwest
    • Minnesota
      • Maplewood、Minnesota、アメリカ、55109
        • 募集
        • USOR Minnesota Oncology Hematology
    • New Jersey
      • Camden、New Jersey、アメリカ、08103
        • 募集
        • MD Anderson Cancer Center at Cooper- Two Cooper Plaza
    • Ohio
      • Columbus、Ohio、アメリカ、43210
        • 募集
        • Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73104
        • 募集
        • University of Oklahoma - Health Sciences Center
    • Oregon
      • Eugene、Oregon、アメリカ、97401
        • 募集
        • USOR Oncology Associates of Oregon, P.C.
      • Portland、Oregon、アメリカ、97227
        • 募集
        • Compass Oncology - Rose Quarter
    • Pennsylvania
      • Doylestown、Pennsylvania、アメリカ、18901
        • 募集
        • USOR Alliance Cancer Specialist
      • Pittsburgh、Pennsylvania、アメリカ、15224
        • 募集
        • Allegheny Health Network
    • Rhode Island
      • Providence、Rhode Island、アメリカ、02905
        • 募集
        • Women and Infants Hospital of Rhode Island
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
        • 募集
        • Tennessee Oncology
      • Nashville、Tennessee、アメリカ、37203
        • 募集
        • Sarah Cannon Research Institute at Tennessee Oncology
    • Texas
      • Abilene、Texas、アメリカ、79606
        • 募集
        • USOR Texas Oncology
      • Austin、Texas、アメリカ、78758
        • 募集
        • Texas Oncology - Central / South Texas
      • Dallas、Texas、アメリカ、75521
        • 募集
        • Mary Crowley Cancer Research
      • Fort Worth、Texas、アメリカ、76104
        • 募集
        • USOR Texas Oncology
      • Tyler、Texas、アメリカ、75702
        • 募集
        • Texas Oncology - Northeast TX
      • Woodland、Texas、アメリカ、77380
        • 募集
        • USOR Texas Oncology Gulf Coast
    • Utah
      • West Valley City、Utah、アメリカ、84119
        • 募集
        • START Mountain Region
    • Virginia
      • Fairfax、Virginia、アメリカ、22031
        • 募集
        • USOR Virginia Cancer Specialists
      • Norfolk、Virginia、アメリカ、23502
        • 募集
        • USOR Virginia Oncology Associates
    • Washington
      • Everett、Washington、アメリカ、98104
        • 募集
        • Swedish Cancer Institute
  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • 募集
        • Cancer hospital, Chinese Academy of Medical Sciences
    • China
      • Fujian、China、中国
        • 募集
        • Fujian Cancer Hospital
      • Guangdong、China、中国
        • 募集
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Henan、China、中国
        • 募集
        • Second Affiliated Hospital of Zhengzhou University
      • Hubei、China、中国
        • 募集
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Shanxi、China、中国
        • 募集
        • Second Hospital of Shanxi Medical University
      • Shanxi、China、中国
        • 募集
        • Shanxi Cancer Hospital
      • Shengyang、China、中国
        • 募集
        • Liaoning Cancer Hospital & Institute
      • Tianjin、China、中国
        • 募集
        • Tianjin Cancer Hospital
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国
        • 募集
        • Chongqing University Cancer Hospital
    • Hunan
      • Changsha、Hunan、中国
        • 募集
        • Hunan Cancer Hospital - Phase 1
      • Changsha、Hunan、中国
        • 募集
        • Hunan Cancer Hospital - Thoracic Medicine Dept II
    • Jiangxi
      • Nanchang、Jiangxi、中国
        • 募集
        • Jiangxi Maternal and Child Health Hospital
    • Jilin
      • Changchun、Jilin、中国
        • 募集
        • Jilin Cancer Hospital
    • Shanghai Municipality
      • Chengdu、Shanghai Municipality、中国
        • 募集
        • Obstetrics & Gynecology Hospital of Fudan University
      • Shanghai、Shanghai Municipality、中国
        • 募集
        • Fudan University Shanghai Cancer Center - Gynecologic Oncology
      • Shanghai、Shanghai Municipality、中国
        • 募集
        • Fudan University Shanghai Cancer Center- Phase 1
      • Shanghai、Shanghai Municipality、中国
        • 募集
        • Shanghai East Hospital
    • Sichuan
      • Shanghai、Sichuan、中国
        • 募集
        • Sichuan Cancer Hospital
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • 募集
        • Zhejiang Cancer Hospital
  • 日本
    • Fukushima
      • Fukushima、Fukushima、日本
        • 募集
        • Fukushima Medical University Hospital
    • Gunma
      • Ōta、Gunma、日本
        • 募集
        • Gunma Prefectural Cancer Center
    • Hokkaido
      • Sapporo、Hokkaido、日本
        • 募集
        • Sapporo Medical University Hospital
    • Hyōgo
      • Akashi、Hyōgo、日本
        • 募集
        • Hyogo Cancer Center
    • Saitama
      • Hidaka、Saitama、日本
        • 募集
        • Saitama Medical University-International Medical Center
    • Shizuoka
      • Nagaizumi-chō、Shizuoka、日本
        • 募集
        • Shizuoka Cancer Center
    • Tokyo
      • Koto、Tokyo、日本
        • 募集
        • Cancer Institute Hospital of JFCR
      • Shinjuku-ku、Tokyo、日本
        • 募集
        • Keio University Hospital
    • Yamagata
      • Yamagata、Yamagata、日本
        • 募集
        • Yamagata University Hospital
  • 韓国
      • Seoul、韓国
        • 募集
        • Korea Institute of Radiological and Medical Sciences

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年歳以上 (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

Inclusion Criteria:

Part A and B:

  • Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).
  • Previously received therapies known to confer clinical benefit.
  • Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.

Part C, E, and H:

Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.

  • High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)
  • Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
  • Participants must have platinum-resistant ovarian cancer.
  • Participants must have received prior bevacizumab or approved biosimilar.
  • Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration [FDA]-approved test in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.
  • Measurable disease per the RECIST v1.1 at baseline.

Part D:

Cohort D1:

  • Participants must have platinum-sensitive ovarian cancer.
  • Participants must have received 1 to 3 prior lines of therapy.

Cohort D2:

  • Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.

  • Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.

  • Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.

    • Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (>183 days) or more from the last dose of platinum-based therapy.

Cohort D3:

• Endometrial cancer (any subtype excluding sarcoma).

Cohort D4:

• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).

Cohort D5

• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).

Part F and G:

  • Participants must have histologically or cytologically confirmed EC.
  • Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
  • Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:
  • Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-[L])1 inhibitor.
  • Participants who progress >12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.
  • Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part I:

  • Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade/borderline ovarian tumors).
  • Participants must have platinum sensitive ovarian cancer.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part J:

  • Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part K:

  • Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).
  • Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
  • Measurable disease per the RECIST Version 1.1 at baseline.

Part L:

  • Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy. Participants must have previously received all therapies known to confer clinical benefit (unless ineligible to receive or refused to receive or therapy is unavailable in the region). If a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented.
  • Participants must either have ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element), or
  • NSCLC.
  • Age 18 to 65 years (inclusive).
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Measurable disease per the RECIST version 1.1 at baseline.

Exclusion Criteria:

  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.

Note: Other protocol-defined inclusion/exclusion 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：Part A, B, C, E, F, G, H, I, J and K

Rina-S monotherapy in Part A and at the recommended dose in Parts B, C, E, F, G, H, I, J and K.
薬：Rina-S

Intravenous infusion of Rina-S

他の名前：
  • PRO1184
  • GEN1184
  • リナタバルト・セステカン
実験的：Part D1

Rina-S in combination with carboplatin
薬：Rina-S

Intravenous infusion of Rina-S

他の名前：
  • PRO1184
  • GEN1184
  • リナタバルト・セステカン
薬：Carboplatin

Carboplatin intravenous infusion
実験的：Part D2 and I

Rina-S in combination with bevacizumab
薬：Rina-S

Intravenous infusion of Rina-S

他の名前：
  • PRO1184
  • GEN1184
  • リナタバルト・セステカン
薬：Bevacizumab

Bevacizumab intravenous infusion
実験的：Part D3, D4 and D5

Rina-S in combination with pembrolizumab
薬：Rina-S

Intravenous infusion of Rina-S

他の名前：
  • PRO1184
  • GEN1184
  • リナタバルト・セステカン
薬：Pembrolizumab

Pembrolizumab intravenous infusion
実験的：Part L

Rina-S in combination with CYP3A4 inhibitors erythromycin or itraconazole.
薬：Rina-S

Intravenous infusion of Rina-S

他の名前：
  • PRO1184
  • GEN1184
  • リナタバルト・セステカン
薬：Erythromycin

Erythromycin oral administration

薬：Itraconazole

Itraconazole oral administration

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
パーツA、B、およびD-治療に発生する有害事象の発生率（TEAES）[安全性と忍容性]
時間枠：治療の終わりまで、約1年まで。
治療の終わりまで、約1年まで。
パートK（米国の参加者のみ） - ホルターによる心電図（ECG）の所見の臨床的に有意な変化を持つ参加者の数
時間枠：サイクル1〜3（各サイクルは21日です）
サイクル1〜3（各サイクルは21日です）
Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)
時間枠：At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)
Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
時間枠：Through end of treatment, up to approximately 1 year.

Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.
Through end of treatment, up to approximately 1 year.
Part L - Peak Plasma Concentration (Cmax) of Rina-S
時間枠：Cycles 1 and 2 (each cycle is 21 days)

Measurement of maximum plasma concentration after the administration of Rina-S.[
Cycles 1 and 2 (each cycle is 21 days)
Part L - Area Under the Plasma Concentration Versus Time Curve (AUC) of Rina-S
時間枠：Cycles 1 and 2 (each cycle is 21 days)

Measurement of AUC after the administration of Rina-S.
Cycles 1 and 2 (each cycle is 21 days)

二次結果の測定

結果測定
メジャーの説明
時間枠
Parts A, B, D, and E -Time to Reach Cmax (Tmax) for Rina-S
時間枠：Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, D, and E - Trough Concentrations (Ctrough) for Rina-S
時間枠：Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, D, and E- Apparent Terminal Half-life (t1/2) for Rina-S
時間枠：Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts C, D, E, H and J - CA-125 Response Determined Using the Gynecologic Cancer Intergroup (GCIG) Criteria
時間枠：Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Part E - Number of Participants With Antidrug Antibodies (ADA)
時間枠：Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Parts A, B, and D - Best Overall Response (BOR)
時間枠：Up to approximately 1 year.

Participants who achieve CR or PR. Best response as assessed by the investigator per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use modified RECIST (mRECIST) v1.1.
Up to approximately 1 year.
Parts A, B, D, and E - ORR
時間枠：Up to approximately 1 year.

Participants who achieve PR or CR per RECIST v1.1 criteria.
Up to approximately 1 year.
Parts A, B, and D - Disease Control Rate (DCR)
時間枠：Up to approximately 1 year.

Participants who achieve stable disease, PR or CR per RECIST v1.1 criteria.
Up to approximately 1 year.
Parts A, B, C, D, E, F, G, H, I, and J - Progression-Free Survival (PFS)
時間枠：Through end of treatment, up to approximately 1 year.

Time from start of treatment to first documented disease progression or death
Through end of treatment, up to approximately 1 year.
Parts C, E, F, G, H, I and J - Overall survival (OS)
時間枠：Up to approximately 2 years.

Time from the start of study treatment to the date of death from any cause
Up to approximately 2 years.
Parts A, B, C, D, E, F, G, H, I and J - Duration of Objective Response (DOR)
時間枠：From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.

Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death
From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.
Parts A, B, D, and E - Cmax for Rina-S
時間枠：Through end of treatment, up to approximately 1 year.

Measurement of maximum plasma concentration after the administration of Rina-S.
Through end of treatment, up to approximately 1 year.
Parts A, B, D, and E - AUC for Rina-S
時間枠：Through end of treatment, up to approximately 1 year.

Measurement of AUC after the administration of Rina-S.
Through end of treatment, up to approximately 1 year.
Parts C, E, F, G, H, I, J, K and L - Number of Participants with Type, Incidence, Severity, Seriousness as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and Relatedness of Adverse Events (AEs)
時間枠：Through end of treatment, up to approximately 1 year
Through end of treatment, up to approximately 1 year
Part L - Number of Participants with DLT
時間枠：At the end of Cycle 1 (each cycle is 21 days)
At the end of Cycle 1 (each cycle is 21 days)

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

Genmab

捜査官

  • スタディディレクター：Study Official、Genmab

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)

2022年12月7日

一次修了 (推定)

2028年12月1日

研究の完了 (推定)

2029年3月1日

試験登録日

最初に提出

2022年10月4日

QC基準を満たした最初の提出物

2022年10月11日

最初の投稿 (実際)

2022年10月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年10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

  • GCT1184-01
  • PRO1184-001 (その他の識別子：Other Sponsor Identifier)
  • CTR20230813 (レジストリ識別子：Chinadrugtrials.org.cn)
  • jRCT2051250094 (レジストリ識別子：Japan Registry for Clinical Trials (jRCT))

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?

いいえ

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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