Phase 2 Study Comparing Efficacy and Safety of ABT-165 and FOLFIRI vs Bevacizumab and FOLFIRI in Metastatic Colorectal Cancer Previously Treated with Fluoropyrimidine/Oxaliplatin and Bevacizumab

Abbvie Deutschland GmbH & Co. KG0 个研究点目标入组 100 人开始时间: 2018年2月7日最近更新: 2020年8月10日

适应症

试验速览

暂无简介。

•- Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
•- At least 1 lesion on a computed tomography (CT) scan that is measurable as defined by RECIST, Version 1.1.
•- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
•- Progression following treatment with fluoropyrimidine(fluorouracil, capecitabine or tegafur)/oxaliplatin/bevacizumab-regimen in the metastatic setting
•- Adequate hematologic, renal and hepatic function
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•- Any prior therapy with irinotecan
•- No unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) = Grade 2
•- No active clinically significant condition(s) that might put the subject at higher risk for anti-angiogenic therapy
•- Prior history of clinically significant: pulmonary hypertension, uncontrolled systemic hypertension or hypertensive crisis, symptomatic heart failure (Heart Association class III – IV), cardiomyopathy, myocardial infarction, unstable/severe angina pectoris, active cardiac arrhythmia, coronary/peripheral artery bypass graft, aneurysm or aneurysm repair, angioplasty, cerebrovascular accident or transient ischemic attack within 1 year of randomization.
•- History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 – 4 bleeding event.

发起方