JPRN-UMIN000016553已完成2 期
Phase 2 study of bevacizumab beyond progression disease for glioblastoma treated with key therapeutics. - BIOMARK
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
研究概览
简要总结
The primary endpoint of BIOMARK was not met (the 2-year survival rate in the BBP group was 27.0% vs. the target of 50%). BBP was initiated in only a small subset (27/90 patients) of the entire cohort, where MGMT-unmethylated tumors were predominant. We identified a novel expression cluster that may predict the prognosis of GBM patients treated with bevacizumab. Further validation of the predictive value of the novel expression classifier is warranted.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Evidence of recent haemorrhage on postoperative magnetic resonance imaging of the brain. (2)Any prior chemotherapy, radiotherapy or immunotherapy (including vaccine therapy) for GBM. (3)Inadequately controlled hypertension. (4)Prior history of hypertensive crisis, or hypertensive encephalopathy. (5)New York Heart Association Grade II or greater congestive heart failure. (6)Other malignancy within 5 years prior to trial enrolment. (7)Active infection requiring systemic treatment. (8)Diabetic with continued insulin treatment or uncontrolled. (9)Have received continued administration of steroids to some systemic disease. (10)Any of the following medical history within 6 months prior to registration. 1)myocardial infarction or unstable angina 2)stroke or TIAs 3)Significant vascular disease 4)Abdominal fistula or perforation of the digestive tract 5)Intracranial abscess (11)History of >= grade 2 hemoptysis within 28 days prior to registration. (12)Evidence of bleeding diathesis or coagulopathy. (13)Serious non-healing wound, active ulcer or untreated bone fracture. (14)Pregnancy or lactation, as well as fertile women and men unwilling or unable to use effective means of contraception. (15)Known hypersensitivity to any of the trial drugs. (16)Patients with allergy to gadolinium. (17)Patients with active hepatic disease. (18)Attending physician has determined unsuitable to participate in the study.
研究者
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