EUCTR2019-004207-13-DK进行中（未招募）1 期
Tocotrienol and Bevacizumab in metastatic colorectal cancer. A randomized phase II marker trial - Toco-CoR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 74
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
- •Histopathologically verified adenocarcinoma of the colon or rectum
- •Metastatic disease
- •Planned treatment with FOLFOX or capecitabine combined with bevacizumab
- •Evaluable disease according to RECIST 1.1
- •Performance status 0-2
- •Expected survival = 3 months
- •Patient acceptance to collection of blood samples for translational research
- •Age = 18 years
- •Contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. Hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted.
- •Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
- •oWBC = 3.0 x 10^9/l or neutrophils (ANC) = 1.5 x 10^9/l
- •oPlatelet count = 100 x 10^9/l
- •oHemoglobin = 6.0 mmol/l
- •oSerum bilirubin = 2.0 x ULN
- •oSerum transaminase = 2.5 x ULN
- •oSerum creatinine = 1.5 ULN
- •Urine dipstick for protein = 2+, if the dipstick shows protein = 2+, 24 hour urine testing must be performed and show protein contents = 1g.
- •Written and orally 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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •Other active malignant disease within 5 years prior to inclusion in the study.
- •Other experimental therapy within 28 days prior to treatment initiation.
- •Underlying medical disease not adequately treated.
- •Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab.
- •Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment
- •Bleeding tumor
- •Pregnant or breastfeeding women
- •Fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment.
- •Hypersensitivity to one or more active substances or auxiliary substances
研究者
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