EUCTR2010-022338-10-DE进行中（未招募）1 期
Phase 2 Study of LY2157299 in Patients with Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 204
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Have histological evidence of a diagnosis of HCC not amenable to
- •curative surgery
- •- Have serum alpha fetoprotein:
- •=1.5 Upper Limit of Normal (Part A)
- •<1.5 Upper Limit of Normal (Part B)
- •- Child-Pugh Class:
- •Parts A and B: A or B7
- •Part C: A
- •- 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
- •- Age =18 years
- •- Have given written informed consent prior to any study-specific
- •- Have adequate hematologic, hepatic and renal function
- •- Have a performance status of =1 on the Eastern Cooperative Oncology
- •Group (ECOG) scale
- •- Have received sorafenib and have progressed or were intolerant to
- •sorafenib or are ineligible for sorafenib treatment (Parts A and B)
- •- Have not received previous systemic treatment (Part C)
- •- 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 =7 days prior to the first dose of study drug
- •- Are able to swallow capsules or tablets
- •- Child-Pugh Class:
- •Parts A and B: A or B7
- •Part C: A
- •- 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
- •- Age =18 years
- •- Have given written informed consent prior to any study-specific
- •- Have adequate hematologic, hepatic and renal function
- •- Have a performance status of =1 on the Eastern Cooperative Oncology
- •Group (ECOG) scale
- •- Have received sorafenib and have progressed or were intolerant to
- •sorafenib or are ineligible for sorafenib treatment (Parts A and B)
- •- Have not received previous systemic treatment (Part C)
- •- 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
- 另有 9 项未显示
排除标准
- •- 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 ascitis
- •- Liver transplant requiring increased immunosuppressive therapy.
- •(Patients on maintenance immunosuppressive therapy after liver
- •transplant are eligible for Parts A and B. Rapamycin analogues are not
- •- Have received > 1 line of systemic treatment (Parts A and B)
- •- Have moderate or severe cardiac disease:
- •a. 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
- •b. Have documented major ECG abnormalities at the investigator's
- •c. Have major abnormalities documented by echocardiography with
- •d. 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 patients who are
- •stable on GnRH agonist therapy and breast cancer patients who are
- •stable on antiestrogen therapy (for example, an aromatase inhibitor)
- •may have that treatment continued while they are enrolled in this study.
- •- 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
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