NCT02520141已完成2 期
A Phase II Study of Ramucirumab for Advanced, Pre-Treated Biliary Cancers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Progression Free Survival of Ramucirumab in Advanced Biliary Cancers
研究概览
简要总结
This phase II trial studies how well ramucirumab works in treating patients with previously treated biliary cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
详细描述
PRIMARY OBJECTIVES:
I. Determine the progression-free survival (PFS) of ramucirumab in advanced biliary cancers (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) who have received prior chemotherapy.
SECONDARY OBJECTIVES:
I. Determine the response rate (RR) and disease control rate (partial response + complete response + stable disease) of ramucirumab in advanced biliary cancers.
II. Determine overall survival (OS) of ramucirumab in advanced biliary cancers. III. Evaluate the toxicity of ramucirumab in advanced biliary cancers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have cholangiocarcinoma, gallbladder cancer or adenocarcinoma on liver biopsy with clinical features consistent with biliary primary/cholangiocarcinoma
- •Metastatic or unresectable disease documented on diagnostic imaging studies
- •Must have received at least one regimen containing gemcitabine chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Total bilirubin =< 1.5 mg/dL (25.65 mol/L)
- •Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3.0 times the upper limit of normal ([ULN]; or 5.0 times the ULN in the setting of liver metastases)
- •Absolute neutrophil count (ANC) >= 1000/uL
- •Hemoglobin >= 9 g/dL (5.58 mmol/L)
- •Platelets >= 100,000/uL
- •The patient does not have:
- •Cirrhosis at a level of Child-Pugh B (or worse) or
- •Cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis; clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
- •Serum creatinine =< 1.5 times the ULN or
- •Creatinine clearance (measured via 24-hour urine collection) >= 40 mL/minute (that is, if serum creatinine is > 1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed
- •The patient's urinary protein is =< 1 positive (+) (=< 30-100 mg/dl) on dipstick or routine urinalysis (urinary analysis [UA]; if urine dipstick or routine analysis is >= 2+ (>=100-300 mg/dl), a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in this protocol)
- •The patient must have adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and
- •Partial thromboplastin time (PTT) (PTT/activated partial thromboplastin time [aPTT]) < 1.5 x ULN)
- •Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin; if receiving warfarin, the patient must have an INR =< 3.0 and no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)
- •The patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
- •Female patients of childbearing potential must have a negative serum pregnancy test within 7 days
- •Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved
- •In the ten patient expanded cohort, patients diagnosed with deoxyribonucleic acid (DNA) repair or FGFR genetic aberrations will be enrolled
排除标准
- •The patient has experienced any grade 3-4 gastrointestinal (GI) bleeding within 3 months prior to enrollment
- •Prior therapy with any agent targeting the vascular endothelial growth factor receptor (VEGFR) pathway to include bevacizumab, pazopanib, and other anti-angiogenesis inhibitors
- •The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism, including portal venous thrombosis (venous port or catheter thrombosis, incidental pulmonary embolism diagnosed on imaging studies or superficial venous thrombosis are not considered significant) during the 3 months prior to randomization
- •The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment
- •The patient has uncontrolled or poorly-controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management
- •The patient has a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment
- •The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
- •The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs ([NSAIDs], including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
- •The patient has elective or planned major surgery to be performed during the course of the clinical trial
- •The patient is pregnant or breast-feeding
结局指标
主要结局
Progression Free Survival of Ramucirumab in Advanced Biliary Cancers
时间窗: Up to 6 years
Progression free survival is measured using 95% confidence intervals. From the date of treatment start to the date of disease progression or to the date of death, whichever occurs first, or to the last follow-up date if patients are alive without disease progression, assessed up to at least 3 months post-treatment
次要结局
- Overall Survival (OS)(Up to 6 years)
- Percentage of Disease Control Rate(Up to 6 years)
- Overall Response Rate (RR)(Up to 6 years)
研究者
研究点 (2)
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