NCT02346032已完成2 期
Phase II Study of Refametinib, a MEK Inhibitor, as Second-line Treatment in Advanced Biliary Tract Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 主要终点
- Response rate
研究概览
简要总结
Phase II Study of Refametinib, a MEK inhibitor, as second-line treatment in advanced biliary tract adenocarcinoma
详细描述
Refametinib will be administered orally at the starting dose of 50 mg twice daily on a continuous daily dosing schedule.
Self-administration of refametinib tablets will take place on an outpatient basis. Patients experiencing dose-limiting toxicity attributed to study medication should have at least 1-week treatment breaks inserted into the continuous daily dosing period as needed and/or may be interrupted or reduced depending on individual tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically or cytologically confirmed adenocarcinoma of biliary tract
- •unresectable or metastatic
- •ECOG performance status of 0~2
- •measurable lesion per RECIST 1.1 criteria
- •adequate marrow, hepatic, renal functions
- •normal range of cardiac function confirmed by echocardiogram within 1 year (LVEF ≥50)
- •Child-Pugh Class A in case of liver cirrhosis
- •One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months)
- •Resolution of all acute toxic effects of any prior therapy to Common Toxicity Criteria for Adverse Events (CTCAE 4.03) ≤ grade
- •provision of a signed written informed consent
排除标准
- •History of cardiac disease
- •Ongoing infection > Grade 2 according to NCI-CTCAE version 4.
- •Hepatitis B is allowed if no active replication (defined as abnormal ALT >2xULN associated with HBV DNA >20,000 IU/mL) is present
- •Severe co-morbid illness and/or active infections including active hepatitis C and human immunodeficiency virus (HIV) infection
- •History of interstitial lung disease (ILD).
- •Any cancer curatively treated < 3 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Staging: Ta, Tis and T1).
- •Renal failure requiring hemo- or peritoneal dialysis.
- •Clinically significant GI bleeding (CTCAE 4.03 grade 3 or higher) within 30 days prior to start of screening
- •Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months prior to start of screening.
- •History of organ allograft, cornea transplantation will be allowed
- •Active CNS metastases not controllable with radiotherapy or corticosteroids
- •Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for RVO or CSR.
- •Known history of hypersensitivity to study drugs
- •Any condition that was unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- •Non-healing wound, ulcer, or bone fracture.
- •Patients with seizure disorder requiring medication.
- •Use of strong inhibitors of CYP3A4 and strong inducers of CYP3A4 should be stopped 2 weeks before start of screening (see Appendix 1).
- •Acute steroid therapy or taper for any purpose (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before start of screening and thereafter).
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- •Pregnant or lactating women. Women of childbearing potential not employing adequate contraception. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of study treatment and a negative result must be documented before first dose of study drug.
研究组 & 干预措施
refametinib
Experimental
refametinib medication
干预措施: refametinib (Drug)
结局指标
主要结局
Response rate
时间窗: 12months
the rate of complete response and partial response among all evaluable patients
次要结局
- Duration of response(12months)
- Progression-free survival(6months)
- adverse events in each cycle were documented based on CTCAE v 4.03(24months)
- Overall survival(12months)
- Exploratory correlative analysis(15 days)
研究者
Ho Yeong Lim
MD, Ph.D, Devision of hematology-oncology, Department of medicine
Samsung Medical Center
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