EUCTR2012-000398-21-GR进行中（未招募）不适用
A proof-of-concept phase 2, randomized, placebo-controlled, double blind, multicentre clinical trial in 2 parallel groups to evaluate the efficacy and safety of E-52862 for reducing the incidence and severity of oxaliplatin-induced peripheral neuropathy in patients treated for colorectal cancer.
aboratorios del Dr. Esteve, S.A.0 个研究点目标入组 120 人开始时间: 2012年8月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •-Being of either sex aged 18 to 80 years.
- •-Having a diagnosis of colorectal cancer made within the prior 2 years.
- •-Having not received chemotherapy with cytotoxic drugs in the past.
- •-Being schedule to start and adjuvant or palliative 6-month chemotherapy regimen for the treatment of their colorectal cancer that includes OXL at a scheduled dose in the first cycle > or equal 60 mg/m2 in a 2-hour infusion (protocols FOLFOX4 and FOLFOX6, with or without cetuximab or bevacizumab supplementation).
- •-Having with a Karnofsky performance status score > or = 70 at screening visit.
- •-Provide a written informed consent to participate in the study.
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •-Pregnant or nursing women. Fertile women must use a reliable contraceptive method to participate in the study.
- •-Patients with any neurologic condition that might interfere with the evaluation of the study objectives, in particular sensory neuropathies (post-herpetic neuralgia, diabetic neuropathy, HIV-related polyneuropathy, central lesions of the somatosensory system such as multiple sclerosis, etc).
- •-Patients with serious and unstable mental illness (symptoms or treatment) that, in the opinion of the investigator, might hamper the conduct of the study.
- •-Patients who have been treated within 30 days prior to screening, are currently treated, or plan to be treated with another investigational product or device during the intended duration of this clinical trial.
- •-Patients with second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator.
- •-Patients with abnormal liver function, renal function impairment or bone marrow impairment in a blood test within 14 days prior to, or at screening.
- •-Patients receiving or who plan to receive any forbidden treatment during the study.
- •-Having a peripheral sensory neuropathy of any NCI-CTCAE grade (>1) at screening visit.
- •-Patients with symptoms suggesting brain metastasis.
- •-Patients with uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •-Patients with a life expectancy shorter than 4 months.
- •-Patients lacking the capacity to understand and provide the required information to achieve the objectives of the study.
研究者
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