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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
204
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Berlin、德国、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、德国、91054
- 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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Göttingen、德国、37075
- 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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Köln、德国、50937
- 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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Mainz、德国、55131
- 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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Münster、德国、48149
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Bari、意大利、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、意大利、00168
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Rozzano、意大利、20089
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Auckland、新西兰、1023
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Brest、法国、29609
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Caen、法国、14033
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Clichy、法国、92110
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Creteil、法国、94010
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Lille、法国、59037
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Lyon、法国、69317
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Marseille、法国、13273
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Montpellier、法国、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、法国、75012
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Pessac、法国、33604
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Saint Etienne、法国、42055
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Saint Herblain、法国、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、法国、67085
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Vandoeuvre Les Nancy、法国、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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Greenslopes、澳大利亚、4120
- 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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Heidelberg、澳大利亚、3084
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St. Leonards、澳大利亚、2065
- 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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Western Australia
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Nedlands、Western Australia、澳大利亚、6009
- 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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Arkansas
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Fayetteville、Arkansas、美国、72703
- Highlands Oncology Group
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California
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San Francisco、California、美国、94158
- University of California, San Francisco
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District of Columbia
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Washington、District of Columbia、美国、20007
- Georgetown University Medical Center
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Florida
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Orlando、Florida、美国、32806
- MD Anderson Cancer Center Orlando
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana Univ Melvin & Bren Simon Cancer Center
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Massachusetts
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Burlington、Massachusetts、美国、01805
- Lahey Clinic Medical Center
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New York
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New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center
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New York、New York、美国、10021
- Weill Cornell Medical College
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University
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Barcelona、西班牙、08035
- 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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Madrid、西班牙、28007
- 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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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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. |
口服给药
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实验性的：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. |
口服给药
口服给药
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实验性的：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. |
口服给药
|
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实验性的：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. |
口服给药
口服给药
|
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实验性的：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. |
口服给药
口服给药
|
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实验性的：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. |
口服给药
管理IV
其他名称：
|
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实验性的：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. |
口服给药
管理IV
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Relationship of Biomarker Alpha-fetoprotein (AFP) to Overall Survival (OS)
大体时间：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)
大体时间：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)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Population Pharmacokinetics (PK) Mean Population Clearance of Galunisertib
大体时间：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
大体时间：Cycle 1 (28 Days)
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Cycle 1 (28 Days)
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Overall Survival (OS)
大体时间：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)
大体时间：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.
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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)
大体时间：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)
大体时间：Time of response to measured progressive disease or death from any cause (Up to 84 Weeks)
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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.
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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)
大体时间：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)
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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)
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Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score
大体时间：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)
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- Li S, Yang F, Ren X. Immunotherapy for hepatocellular carcinoma. Drug Discov Ther. 2015 Oct;9(5):363-71. doi: 10.5582/ddt.2015.01054.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年3月30日
初级完成 (实际的)
2019年6月6日
研究完成 (实际的)
2019年12月24日
研究注册日期
首次提交
2010年11月1日
首先提交符合 QC 标准的
2010年11月23日
首次发布 (估计)
2010年11月24日
研究记录更新
最后更新发布 (实际的)
2021年1月12日
上次提交的符合 QC 标准的更新
2020年12月21日
最后验证
2020年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 13665
- H9H-MC-JBAK (其他标识符：Eli Lilly and Company)
- 2010-022338-10 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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 共享时间框架
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 共享访问标准
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.