A Study of LY2157299 in Participants With Hepatocellular Carcinoma
2020年12月21日 更新者：Eli Lilly and Company
Phase 2 Study of LY2157299 in Patients With Hepatocellular Carcinoma
The purpose of this study is to estimate the median time to progression in participants with hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination with sorafenib or ramucirumab.
調査の概要
詳細な説明
The study consists of four Parts: Part A where HCC participants with an increased alpha-fetoprotein (AFP) level will be treated with either 160 milligrams (mg) LY2157299 or 300 mg LY2157299. Part B where HCC participants with a normal AFP level will be treated with 300 mg LY2157299, Part C where treatment-naïve HCC participants will be treated with 160 mg LY2157299 + sorafenib or 300 mg LY2157299 + sorafenib, and Part D where HCC participants will be treated with either 160 mg or 300 mg LY2157299 + ramucirumab.
Participants who continue to receive benefit from treatment at the time that the study is considered completed, may enter the treatment extension period and continue to receive the study treatment. The end of the study is the date of last visit or last scheduled procedure for the last active subject in the study.
研究の種類
介入
入学 (実際)
204
段階
- フェーズ2
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
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Arkansas
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Fayetteville、Arkansas、アメリカ、72703
- Highlands Oncology Group
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California
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San Francisco、California、アメリカ、94158
- University of California, San Francisco
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District of Columbia
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Washington、District of Columbia、アメリカ、20007
- Georgetown University Medical Center
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Florida
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Orlando、Florida、アメリカ、32806
- MD Anderson Cancer Center Orlando
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Indiana Univ Melvin & Bren Simon Cancer Center
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Massachusetts
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Burlington、Massachusetts、アメリカ、01805
- Lahey Clinic Medical Center
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New York
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New York、New York、アメリカ、10065
- Memorial Sloan Kettering Cancer Center
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New York、New York、アメリカ、10021
- Weill Cornell Medical College
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- Thomas Jefferson University
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Bari、イタリア、70124
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rome、イタリア、00168
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rozzano、イタリア、20089
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Greenslopes、オーストラリア、4120
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Heidelberg、オーストラリア、3084
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St. Leonards、オーストラリア、2065
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Western Australia
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Nedlands、Western Australia、オーストラリア、6009
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Barcelona、スペイン、08035
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Madrid、スペイン、28007
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Berlin、ドイツ、13353
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Erlangen、ドイツ、91054
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Göttingen、ドイツ、37075
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Köln、ドイツ、50937
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Mainz、ドイツ、55131
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Münster、ドイツ、48149
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Auckland、ニュージーランド、1023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Brest、フランス、29609
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Caen、フランス、14033
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Clichy、フランス、92110
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Creteil、フランス、94010
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Lille、フランス、59037
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Lyon、フランス、69317
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Marseille、フランス、13273
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Montpellier、フランス、34295
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Paris、フランス、75012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pessac、フランス、33604
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saint Etienne、フランス、42055
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Saint Herblain、フランス、44805
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Strasbourg、フランス、67085
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vandoeuvre Les Nancy、フランス、54511
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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:
- Have histological evidence of a diagnosis of HCC not amenable to curative surgery
- Part A: Serum alpha fetoprotein greater than or equal to 1.5 Upper Limits of Normal, Part B: Serum alpha fetoprotein less than 1.5 Upper Limits of Normal. Not applicable for Part C or D
- Child-Pugh Stage: A or B7 for Parts A & B, A for Part C, and D
- Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). A lesion that has been previously treated by local therapy will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy
- Have given written informed consent prior to any study-specific procedures
- Have adequate hematologic, hepatic and renal function
- Have a performance status of equal to or less than 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- For Parts A & B: Have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment. For Part C: not received previous systemic treatment. For Part D: have received sorafenib and have progressed or were intolerant to sorafenib or are ineligible for sorafenib treatment or have not received prior systemic treatment.
- For Parts A, B, and D: have discontinued sorafenib for at least 2 weeks
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
- Females with childbearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
- Are able to swallow capsules or tablets
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an investigational drug or device or not approved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Known HCC with fibro-lamellar or mixed histology
- Presence of clinically relevant ascites
- History of liver transplant requiring increased immunosuppressive therapy. (Participants on maintenance immunosuppressive therapy after liver transplant are eligible for Part A & B)
- Have received more than 1 line of systemic treatment in Parts A, B and D
Have moderate or severe cardiac disease:
- Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension
- Have documented major electrocardiogram (ECG) abnormalities at the investigator's discretion
- Have major abnormalities documented by echocardiography with Doppler
- Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress
- Have serious preexisting medical conditions that, in the opinion of the investigator, that cannot be adequately controlled with appropriate therapy or would preclude participation in this study
- Females who are pregnant or lactating
- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years. At the discretion of the investigator, hormone-refractory prostate cancer participants who are stable on GnRH agonist therapy and breast cancer participants who are stable on antiestrogen therapy may have that treatment continued
- Have active infection that would interfere with the study objectives or influence study compliance
- For Part C, have a known hypersensitivity to sorafenib or its excipients
For Part D, have a serious illness or medical condition(s), including but not limited to the following:
- The participant has undergone major surgery within 28 days prior to randomization or has undergone central venous access device placement within 7 days prior to randomization
- The participant has uncontrolled arterial hypertension ≥150 / ≥90 millimeters of mercury (mm Hg) despite standard medical management
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：並列代入
- 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 |
|---|---|
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実験的：Part A Cohort 1-160 milligram (mg) LY2157299
Per the protocol, following an interim analysis, the decision was taken to no longer randomize participants to the 160 mg LY2157299 arm. As of May 25,2012, all newly enrolled participants will receive 300 mg LY2157299. 80 mg LY2157299 given orally twice daily (BID) for 14 days followed by 14 days off (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
経口投与
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実験的：Part A Cohort 2 - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
経口投与
経口投与
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実験的：Part B - 300 mg LY2157299
150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
経口投与
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実験的：Part C Cohort 1 - 160 mg LY2157299 + 800 mg Sorafenib
80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
経口投与
経口投与
|
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実験的：Part C Cohort 2 - 300 mg LY2157299 + 800 mg Sorafenib
150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
経口投与
経口投与
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実験的：Part D Cohort 1 - 160 mg LY2157299 + 8 mg/kg Ramucirumab
80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
経口投与
投与された IV
他の名前：
|
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実験的：Part D Cohort 2 - 300 mg LY2157299 + 8 mg/kg Ramucirumab
150 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle). Participants will continue to receive until disease progression, unacceptable toxicity, or another withdrawal criterion is met. |
経口投与
投与された IV
他の名前：
|
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 |
|---|---|---|
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Change From Baseline in Relationship of Biomarker Alpha-fetoprotein (AFP) to Overall Survival (OS)
時間枠：Baseline, discontinuation from any cause (Up to 83 months)
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Biomarker response was defined as a > 20% decrease in the biomarker AFP from baseline during 8 weeks of treatment.
Data presented is median overall survival of those participants who achieved the defined biomarker response.
Participants enrolled in Part A had a baseline AFP level of >1.5 upper limit normal (ULN).
Participants enrolled in Part B had baseline AFP level <1.5 ULN.
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Baseline, discontinuation from any cause (Up to 83 months)
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Change From Baseline in Relationship of Biomarker Transforming Growth Factor - Beta (TGF-β) to Overall Survival (OS)
時間枠：Baseline,discontinuation from any cause (Up to 83 months)
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Biomarker response was defined as a > 20% decrease in the biomarker TGF-B from baseline.
Data presented is median overall survival of those participants who achieved biomarker response.
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Baseline,discontinuation from any cause (Up to 83 months)
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Time to Progression (TTP)
時間枠：Randomization to date of first measured progressive disease (Up to 36 Weeks)
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TTP is measured from the date of first dose to the first date of progression of disease based on the investigator review of tumor response using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of 1 or more new lesions is also considered progression.
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Randomization to date of first measured progressive disease (Up to 36 Weeks)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Population Pharmacokinetics (PK) Mean Population Clearance of Galunisertib
時間枠：Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours(h) Postdose; D14: Predose, 0.5-2, 3-5 h, Postdose; D15 Morning; D22 Morning; Predose C2 and C3 Predose D1
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Population mean (between-subject coefficient variance [CV %]) apparent clearance.
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Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours(h) Postdose; D14: Predose, 0.5-2, 3-5 h, Postdose; D15 Morning; D22 Morning; Predose C2 and C3 Predose D1
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Recommended Dose for Phase 3 Hepatocellular Carcinoma (HCC) Trials
時間枠：Cycle 1 (28 Days)
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Cycle 1 (28 Days)
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Overall Survival (OS)
時間枠：Randomization to date of death from any cause (Up to 83 months)
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OS duration is measured from the date of first dose to the date of death from any cause.
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Randomization to date of death from any cause (Up to 83 months)
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Progression Free Survival (PFS)
時間枠：Randomization to measured progressive disease or death from any cause (Up to 45 Weeks)
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PFS duration is measure from the date of first dose to the first date of objective progression of disease or death from any cause.
Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of 1 or more new lesions is also considered progression.
|
Randomization to measured progressive disease or death from any cause (Up to 45 Weeks)
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Percentage of Participants Achieving an Objective Response (Response Rate)
時間枠：Randomization to measured progressive disease (Up to 36 Weeks)
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The percentage of participants who achieved best overall response of either Complete Response (CR) or Partial Response (PR).
The overall response rate for each dose with be estimated by dividing the number of confirmed responders by the number of participants who received at least one dose of study drug.
Per RECIST v.1.0
criteria CR is defined as disappearance of all target lesions.
Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm).
Tumor-marker results must have normalized.
PR is defined as at least 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
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Randomization to measured progressive disease (Up to 36 Weeks)
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Duration of Tumor Response (DoR)
時間枠：Time of response to measured progressive disease or death from any cause (Up to 84 Weeks)
|
DoR is measured from the date of the first objective status assessment of a Complete Response (CR) or Partial Response (PR), as determined by RECIST v1.1, to the first date of objective progression of disease or death from any cause.
CR is defined as disappearance of all target lesions.
Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm).
Tumor-marker results must have normalized.
PR is defined as at least 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of 1 or more new lesions is also considered progression.
|
Time of response to measured progressive disease or death from any cause (Up to 84 Weeks)
|
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Time to Treatment Failure (TTF)
時間枠：Randomization to the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause (Up to 75 Weeks)
|
TTF is measured from the date of first dose until the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause.
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Randomization to the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause (Up to 75 Weeks)
|
|
Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score
時間枠：Baseline, Day 1 Cycle 4
|
FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72; FACT-Hep score range 1-180, and Trial-Outcome Index (TOI) score range 1-128, to assess health related quality of life in participants with cancer.
Higher scores reflect a better health state.
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Baseline, Day 1 Cycle 4
|
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Time to Worsening (TTW) of Symptoms (FACT-Hep)
時間枠：Baseline to the worsening of symptoms (up to 567 days)
|
Time to worsening of symptoms used minimally important differences to evaluate Physical Well Being (PWB), Functional Well Being (FWB), Hepatocellular Cancer Symptoms (HCS), National Comprehensive Cancer Network (NCCN)/FACT Hepatocellular Symptoms (FHS), Trial-Outcome Index (TOI).
PWB time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; FWB time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; HCS time to worsening was defined as participants who had change in a subscale of ≥ 5 point decrease from baseline; FHS time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; TOI time to Worsening was defined as participants who had change in the subscale of ≥ 7 point decrease from baseline.
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Baseline to the worsening of symptoms (up to 567 days)
|
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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
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
- Giannelli G, Santoro A, Kelley RK, Gane E, Paradis V, Cleverly A, Smith C, Estrem ST, Man M, Wang S, Lahn MM, Raymond E, Benhadji KA, Faivre S. Biomarkers and overall survival in patients with advanced hepatocellular carcinoma treated with TGF-betaRI inhibitor galunisertib. PLoS One. 2020 Mar 25;15(3):e0222259. doi: 10.1371/journal.pone.0222259. eCollection 2020. Erratum In: PLoS One. 2020 Jun 25;15(6):e0235580. PLoS One. 2021 Jun 17;16(6):e0253671.
- Addepalli A, Kalyani S, Singh M, Bandyopadhyay D, Mohan KN. CalPen (Calculator of Penetrance), a web-based tool to estimate penetrance in complex genetic disorders. PLoS One. 2020 Jan 29;15(1):e0228156. doi: 10.1371/journal.pone.0228156. eCollection 2020. Erratum In: PLoS One. 2020 Jun 25;15(6):e0235547.
- Faivre S, Santoro A, Kelley RK, Gane E, Costentin CE, Gueorguieva I, Smith C, Cleverly A, Lahn MM, Raymond E, Benhadji KA, Giannelli G. Novel transforming growth factor beta receptor I kinase inhibitor galunisertib (LY2157299) in advanced hepatocellular carcinoma. Liver Int. 2019 Aug;39(8):1468-1477. doi: 10.1111/liv.14113. Epub 2019 Jun 3.
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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)
2011年3月30日
一次修了 (実際)
2019年6月6日
研究の完了 (実際)
2019年12月24日
試験登録日
最初に提出
2010年11月1日
QC基準を満たした最初の提出物
2010年11月23日
最初の投稿 (見積もり)
2010年11月24日
学習記録の更新
投稿された最後の更新 (実際)
2021年1月12日
QC基準を満たした最後の更新が送信されました
2020年12月21日
最終確認日
2020年1月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 13665
- H9H-MC-JBAK (その他の識別子：Eli Lilly and Company)
- 2010-022338-10 (EudraCT番号)
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
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 共有時間枠
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD 共有アクセス基準
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
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。