EUCTR2006-002893-23-DE进行中（未招募）不适用
An Open Label Single Arm Phase 1b/2 Study with Pharmacokinetic Sampling to Evaluate LY2181308 in Patients with Advanced Hepatocellular Carcinoma - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Patients may be included in the study only if they meet all of the following criteria:
- •1. Patients previously diagnosed with HCC. Primary HCC diagnoses may be
- •histopathological, cytological, or clinically confirmed. Patients with only a
- •clinical diagnosis of HCC are acceptable, if diagnosis was made following the
- •AASLD-EASL diagnostic consensus. Patients entering the trial after
- •progression from a previous liver cancer therapy do not need to be rebiopsied.
- •Progression, per modified RECIST criteria (Attachment JACS.7),
- •should be documented before entering the trial.
- •2. HCC in a BCLC (refer to Protocol Attachment JACS.5) stage at the time of
- •entering the trial of either intermediate (B) or advanced (C) groups. Early stage
- •tumors (A) can be enrolled if any of the potentially curative standard therapies
- •for these cases [i.e. liver transplantation, surgical resection, transcatheter
- •arterial chemoembolization (TACE) or percutaneous embolization] is excluded
- •due to tumor localization, patient’s underlying conditions or because of tumor
- •recurrence.
- •3. Patients must have discontinued and recovered from the acute effects of all
- •previous therapies for their cancer (e.g., sorafenib, chemotherapy,
- •radiotherapy, or other investigational therapy) for at least 2 weeks prior to
- •enrollment (3 weeks in the case of cytotoxics).
- •4. For Phase 2 only: Measurable disease by modified RECIST criteria for HCC
- •(See Attachment JACS.7). Patient should have at least one lesion which has
- •not been previously treated locally with percutaneous or transcatheter arterial
- •chemoembolization (TACE).
- •5. Liver function determined in Child-Pugh class A or B of 7 points (refer to
- •Protocol Attachment JACS.6).
- •6. Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG)
- •performance status scale. (refer to Protocol Attachment JACS.3)
- •7. The following laboratory results:
- •Hematology
- •Neutrophils =1.5 x 10E9/L
- •Hemoglobin =9g/dL
- •Platelets =100 x 10E9/L
- •Any bilirubin and albumin values that are within the acceptable range per
- •the Child Pugh Score will be eligible for participation (See inclusion criteria #5)
- •Alanine Aminotransferase (ALT) =10 times ULN
- •Aspartate Aminotransferase (AST) =10 times ULN
- •Alkaline Phosphatase (AP) =5 times ULN
- •Coagulation: Activated partial thromboplastin time (aPTT) =1.5 times ULN
- •and International Normalized Ratio (INR) of prothrombin time <1.7
- •Patients on treatment with less than 40 mg/day of furosemide and 100
- •mg/day of spironolactone for ascites control (or equivalent).
- •Calculated creatinine clearance by Cockcroft-Gault formula =50 mL/min
- •(refer to Protocol Attachment JACS.8).
- •8. Female patients of child-bearing potential must have a negative pregnancy
- •test at the time of enrollment based on a serum pregnancy test. Male and
- •female patients must agree to use a reliable method of birth control during
- •and for 3 months following the last dose of study drug.
- •9. Patient must be reliable, compliant with study procedures, and willing to be
- •available for all study visits for the duration of the study.
- •10. Patient must sign an Institutional Review Board approved informed consent
- 另有 8 项未显示
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •1. HCC that could be treated with potentially curative or effective palliative
- •therapies (e.g., surgical resection, liver transplant, percutaneous ablation,
- •transcatheter arterial embolization (TACE), sorafenib and/or other proven
- •effective therapies).
- •2. Patients who have received a liver transplant.
- •3. Second primary malignancy except in situ carcinoma of the cervix or
- •adequately treated non-melanomatous carcinoma of the skin or other
- •malignancy treated at least 5 years previously with no evidence of recurrence;
- •prior low grade [Gleason score =6] localized prostate cancer is allowed.
- •4. Previous systemic antisense oligonucleotide treatment.
- •5. Hepatic encephalopathy of any degree or requirement for chronic treatment to
- •control (it is acceptable to enroll patients with one or more previous events that
- •were short-lived which remained without treatment).
- •6. Concurrent chronic infection with Human Immunodeficiency Virus (HIV).
- •7. Patients who have received treatment within the last 30 days with a drug that
- •has not received regulatory approval for any indication at the time of study
- •8. Patients with active alcohol abuse or illicit drug use.
- •9. Patients with serious concomitant systemic disorders that, in the opinion of the
- •investigator, would compromise the safety of the patient or compromise the
- •patient’s ability to complete the study.
- •10. Female patients who are pregnant or breast-feeding.
- •11. Symptomatic or proven central nervous system (CNS) neoplasm.
- •12. Concomitant anticancer therapy or anticoagulant therapy (with the exception of
- •the use of heparinized saline to maintain patency of central venous catheters).
- •13. Patients taking acetylsalicylic acid (ASA, aspirin) and NSAIDS less than one
- •week prior to treatment.
- •14. Patients taking G-CSF (Growth-Colony Stimulating Factor) less than 24 hours
- •prior to the start of therapy.
- •15. Patients who require palliative radiotherapy at the time of study entry.
- •16. Patients with more than 2 previous systemic chemotherapy treatments
- •(excluding tamoxifen).
研究者
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