EUCTR2008-007155-27-DE进行中（未招募）不适用
A Randomized Controlled Phase 2 Trial of ARQ 197 in Patients with Unresectable Hepatocellular Carcinoma (HCC) Who Have Failed One Prior Systemic Therapy - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ArQule, Inc.
- 入组人数
- 99
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
- •Each prospective subject must meet ALL of the following inclusion
- •criteria in order to be eligible for this study:
- •1. Written informed consent granted prior to initiation of any study
- •specific screening procedures
- •2. 18 year of age or older
- •3. Histologically or cytologically confirmed HCC
- •4. Archival, fresh core needle biopsy or fine needle aspiration (FNA)
- •tumor samples
- •5. Received at least one cycle of prior systemic therapy (at least 3 weeks
- •for continuously administered drugs) and experienced radiographic
- •disease progression or was unable to tolerate therapy. If intolerance
- •was manifested by a Grade 3 or 4 event of such nature that re-challenge
- •is not acceptable, less than 3 weeks of continuous administration will be
- •6. Discontinued prior treatment for at least 4 weeks, or at least 2 weeks
- •(14 days) if drug was administered continuously and orally (e.g.
- •sorafenib or sunitinib), prior to the study randomization
- •7. Eastern Cooperative Oncology Group (ECOG) performance status (PS)
- •=1 (Appendix 2)
- •8. Local or loco-regional therapy (i.e., surgery, radiation therapy, hepatic
- •arterial embolization, chemoembolization, radiofrequency ablation,
- •percutaneous ethanol injection, or cryoablation) must have been
- •completed =4 weeks prior to randomization.
- •9. Measurable disease as defined by a modified version of the revised
- •Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. (See
- •Section 9) Tumor lesions previously treated with local therapy should
- •demonstrate clear dimensional increase by radiographic assessment in
- •order to be selected as target lesion(s) at baseline. (Radiological
- •assessment needs to be redone within 7 days prior to randomization if
- •the pre-study AFP levels has increased by more than 30% since the last
- •AFP level taken one to four months prior to randomization).
- •10. Adequate bone marrow, liver, and renal functions at Pre-Study Visit,
- •defined as:
- •- Platelet count = 60 × 109/L
- •- Hemoglobin = 9.0 g/dL
- •- Absolute neutrophil count (ANC) =1.5 × 109/L
- •- Total bilirubin = 2 mg/dL
- •- Alanine transaminase (ALT) and aspartate transaminase (AST) = 5 ×
- •upper limit of normal (ULN)
- •- Serum creatinine =1.5 × ULN
- •- International normalized ratio (INR) 0.8 to 1.4 or =3 for patients
- •receiving anticoagulant such as coumadin or heparin. Patients who are
- •therapeutically anticoagulated are allowed to participate provided that
- •no prior evidence of underlying abnormality exists in these parameters
- •- Albumin = 2.8 g/dL
- •11. Women of childbearing potential must have a negative pregnancy
- •test performed within ten days prior to the start of study drug.
- •12. Male and female subjects of child-bearing potential must agree to
- •use double-barrier contraceptive measures, oral contraception, or
- •avoidance of intercourse during the study and for 90 days after last
- •investigational drug dose received.
- 另有 6 项未显示
排除标准
- •Potential subjects who meet ANY of the following exclusion criteria are
- •not eligible for enrollment into this study:
- •1. More than 1 prior systemic regimen.
- •2. Child-Pugh Class B-C cirrhotic status (See Appendix 4 for Child-Pugh
- •Classification)
- •3. Previous or concurrent cancer that is distinct from HCC in primary site
- •or histology, EXCEPT cervical carcinoma in situ, treated basal cell
- •carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer
- •curatively treated >3 years prior to enrollment is permitted.
- •4. History of congestive heart failure defined as Class II to IV per New
- •York Heart Association (NYHA) classification within 6 months prior to
- •study entry; active coronary artery disease (CAD); clinically significant
- •bradycardia or other uncontrolled cardiac arrhythmia defined as = Grade
- •3 according to NCI CTCAE, version 4.0, or uncontrolled hypertension;
- •myocardial infarction occurring within 6 months prior to study entry
- •(myocardial infarction occurring > 6 months prior to study entry is
- •permitted).
- •5. Active clinically serious infections defined as = Grade 3 according to
- •NCI CTCAE, version 4.0.
- •6. Substance abuse, medical, psychological or social conditions that may,
- •in the opinion of the Investigator, interfere with the patient's
- •participation in the study or evaluation of the study results
- •7. Any condition that is unstable or which could jeopardize the safety of
- •the patient and his/her protocol compliance
- •8. Known human immunodeficiency virus (HIV) infection
- •9. Pregnancy or breast-feeding.
- •10. History of liver transplant
- •11. Inability to swallow oral medications
- •12. Clinically significant gastrointestinal bleeding occurring =4 weeks
- •prior to randomization.
研究者
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