EUCTR2018-001414-15-IT招募中1 期
Randomized phasE 2 study of Valproic acid in combination with bevacizumab and Oxaliplatin/fLUoropyrimidine regimens in patients with ras-mutated metastaTIc cOlorectal caNcer - REVOLUTIO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Main inclusion criteria
- •Histologically confirmed diagnosis of colorectal adenocarcinoma
- •Stage IV of disease (according to TNM 8th edition)
- •RAS mutations
- •Clinical or radiologic evidence of disease (at least one target according to RECIST 1.1)
- •ECOG performance status 0 to 1
- •Life expectancy > 3 months
- •Use of an acceptable mean of contraception for men and women of childbearing potential
- •Adequate recovery from previous surgery. At least 28 days should elapse from a surgical procedure or from performing a biopsy for the enrolment into the study
- •Written 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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Main exclusion criteria
- •Tumors without RAS mutations
- •Prior chemotherapy or any other medical treatment for advanced mCRC (previous adjuvant chemotherapy is allowed if ended > 6 months before relapse or > 24 months if the adjuvant treatment included oxaliplatin)
- •Radiotherapy to any site for any reason within 28 days prior to randomization (palliative radiotherapy to bone lesions is allowed if = 14 days before randomization)
- •Any other invasive malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA)
- •Patient who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Pregnancy or nursing
- •Concomitant pathologies or laboratory alterations or concomitant medications use that prevent or contraindicate the use of study drugs
- •Brain metastases
研究者
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