EUCTR2012-005626-30-BE进行中（未招募）1 期
Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced (non resectable) and metastatic cholangiocarcinoma: a randomized double-blinded phase II trial. - REACH I
CUB Erasme Hospital0 个研究点目标入组 66 人开始时间: 2013年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
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
- •- histologically proven locally advanced unresectable or metastatic intra-hepatic or hilum cholangiocarcinoma or histologically proven metastatic extra-hepatic cholangiocarcinoma (common bile duct and gallbladder)
- •- progression documented after GEM-CDDP (or GEM-OX), or gemcitabine alone followed or preceded by platinum-based chemotherapy
- •- signed written informed consent
- •- Male or female = 18 years of age
- •- ECOG PS 0/1 at study entry
- •- measurable disease according to RECIST version 1.1
- •- adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
- •oSerum creatinine =1.5x upper reference range
- •oTotal bilirubin =1.5x ULN
- •oAlanine transaminase (ALT) and aspartate aminotransferase (AST) = 3.0x ULN (<5x ULN for patients with liver involvement of their cancer).
- •oAmylase and lipase =1.5x ULN.
- •oAlkaline phosphatase (ALP) = 2.5x ULN (=5x ULN for patients with liver involvement of their cancer and /or have bone metastases)
- •oPlatelets count =100.000/mm³, hemoglobin (Hb) =9 g/dL, absolute neutrophil count (ANC) =1500/mm³
- •oInternation normalized ratio (INR) =1.5x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) = 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant, e.g. heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care.
- •- life expectancy of at least 12 weeks
- •- effective contraception for both male and female patients must be used for at least 8 weeks after the last study drug administration if the risk of conception exists
- •- negative pregnancy test, only applicable if there is a risk of conception
- •- negative proteinuria on dipstick or 24 hours proteinuria<1000mg
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •- unability to take oral medication
- •- any malabsorption condition
- •- patients taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg. Clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg. Carbamazepine, phenobarbital, phenytoin, rifampin, St-John’s Wort)
- •- persistent proteinuria >3.5g/24 hours measured by urine protein-creatinine ratio from a random urine sample (persistent proteinuria >3 non-healing woud, ulcer, or bone fracture
- •- patients with evidence or history of any bleeding diathesis, irrespective of severity
- •- any hemorrhage or bleeding event = CTCAE Grade 3 within 4 weeks prior to the start of study medication
- •- interstitial lung disease with ongoing signs and symptoms at the time of informed consent
- •- uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
- •- history of myocardial infarction (6 months before start of study drug)
- •- arterial or venous thrombotic events such as cerebrovascular accident (CVA) (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication)
- •- uncontrolled cardiac arrhythmias
- •- previous exposure to anti-VEGF targeting therapy (including Regorafenib) and to signal transduction inhibitors
- •- known hypersensitivity to any of the components of study treatments
- •- previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
- •- pregnant or lactating women, or patients of both genders with procreative potential not using adequate contraceptive methods
- •- medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
- •- unstable angina, congestive heart failure =NYHA class II
- •- uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg)
- •- pheochomocytoma
- •- HIV infection
- •- active chronic hepatitis B or C with a need for antiviral treatment
- •- brain metastasis
- •- major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment
- •- intra-hepatic locoregional therapy (DC Beads, SIRT)
- •- history of organ allograft
- •- ongoing infection > grade 2 NCI CTCAE
- •- renal failure requiring dialysis
- •- patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study
研究者
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