EUCTR2015-004544-18-GB进行中（未招募）1 期
An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic COlorectal cancer who are non-eligible for intensive therapy - TASCO1 study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 153
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
- •- Written informed consent obtained.
- •- Male or Female participant aged =18 years old.
- •- Has ECOG performance status of 0, 1 or 2 at the time of the randomisation.
- •- Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- •- RAS status must have been determined (mutant or wild).
- •- Has at least one measurable metastatic lesion.
- •- No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
- •- Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment.
- •- Patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
- •- Is able to take medication orally (i.e., no feeding tube).
- •- Has adequate organ function.
- •- Coagulation parameters in normal limit (or in therapeutic limit for patients treated with anticoagulant drugs).
- •- Women of childbearing potential must have been tested negative in a serum pregnancy test. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. Women and female partners using hormonal contraceptive must also use a barrier method.
- •- Is willing and able to comply with scheduled visits and study procedures.
- •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 110
排除标准
- •- Foreseeable poor compliance to the study procedures.
- •- Is a pregnant or lactating female.
- •- Is inappropriate for entry into this study in the judgment of the Investigator.
- •- Has certain serious illness or serious medical condition(s) described in the protocol.
- •- Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
- •- Has previously received S 95005 or history of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
- •- Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- •- Has contra-indication to bevacizumab or capecitabine.
研究者
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