EUCTR2010-021037-32-DE进行中（未招募）1 期
A study for people with advanced colorectal cancer who have been treated with a specific chemotherapy regimen (Bevacizumab, Oxaliplatin, and a Fluoropyrimidine) which was ineffective in stopping the spread of the colorectal cancer. Study participants will receive a different chemotherapyregimen (Irinotecan, Folinic Acid, and 5-Fluorouracil) and be randomly andunknowingly assigned to also receive the study drug (ramucirimab) or a non-active compound (placebo)
Eli Lilly and Company Limited, Indianapolis0 个研究点目标入组 1,050 人开始时间: 2010年12月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,050
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 or cytologically confirmed metastatic colorectal cancer excluding primary tumors of appendiceal origin (patients are eligible to enroll irrespective of KRAS mutation status)
- •- Confirmed metastatic colorectal cancer (Stage IV)
- •- The patient has received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and a)Experienced radiographic disease progression during first-line therapy, or b)Experienced radiographic disease progression within 6 months after the last dose of first-line therapy, or c)Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression within 6 months after the last dose of first-line therapy; Note that a patient must have received a minimum of 2 doses of bevacizumab as part of a first-line regimen containing chemotherapy. In addition, a patient must have received at least 1 cycle of first-line therapy that included bevacizumab, oxaliplatin, and a fluoropyrimidine inthe same cycle. Note that a patient must not have received more than 2 different fluoropyrimidines as part of a first-line regimen; disease progression is not an acceptable reason for discontinuing one fluoropyrimidine and starting a second fluoropyrimidine.
- •- Receipt of no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted). Note that re-challenge with oxaliplatin is permitted and will be considered part of 1 first-line regimen for metastatic disease.
- •- Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v. 1.1)
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •- Adequate hematologic, renal, hepatic and coagulation function
- •- Consent to provide a historical colorectal cancer tissue sample for assessment of biomarkers and the tumor tissue sample is available
- •- Ability to provide signed informed consent
- •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 472
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 578
排除标准
- •- Receipt of bevacizumab within 28 days prior to randomization
- •- Receipt of any investigational therapy within 28 days prior to randomization
- •- Receipt of any previous systemic therapy, other than a combination of bevacizumab, oxaliplatin, and a fluoropyrimidine, for first-line treatment of metastatic colorectal cancer
- •- Known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression
- •- Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 12 months prior to randomization
- •- Pregnant (confirmed by serum beta human chorionic gonadotropin [ß HCG] test within 7 days prior to randomization) or lactating
- •- History of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) in the 12 months prior to randomization
- •- Acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator
- •- Grade 3 or higher bleeding event within 3 months prior to randomization
- •- Experience of any of the following during first-line therapy with a bevacizumab-containing regimen: an arterial thrombotic/thromboembolic event, Grade 4 hypertension, Grade 3 proteinuria, a Grade 3-4 bleeding event, or bowel perforation
- •- Known history or clinical evidence of Gilbert's Syndrome, or is known to have any of the following genotypes: UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28
- •- Known allergy to any of the study treatment components, including any components used in the preparation of ramucirumab, or other contraindication to receive the study treatments
- •- The patient has:
- •? 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 resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
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