EUCTR2012-001367-76-BG进行中（未招募）1 期
A double blinded, randomized, multi centre, three armed phase II trial of PledOx in two different doses in combination with FOLFOX6 compared to placebo + FOLFOX6 in patients with metastatic colorectal cancer - PLIANT
PledPharma AB0 个研究点目标入组 180 人开始时间: 2013年4月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
- •1.Advanced metastatic colorectal (stage IV) cancer verified by biopsy
- •2.Patients may have received up to three previous treatment lines of chemotherapy, which may include fluoropyrimidine, irinotecan and targeted therapies. The last dose of antitumor drug must be given at least 4 weeks prior to inclusion and all toxicity (except alopecia and fatigue) resolved. Patients may also be chemotherapy-naïve, have received prior adjuvant treatment but no previous treatment with oxaliplatin
- •3.CT-scan or MRI of thorax, abdomen and pelvis; within =4 weeks before start of chemotherapy
- •4.Evaluable disease and one measurable site of disease according to RECIST 1.1 criteria (at least 10 mm for CT-scan or MRI)
- •5.Neurological examination with no significant pathological findings
- •6.=18 years
- •7.WHO performance status 0=2 and Life expectancy = 3 months
- •8.Adequate haematological function, Hb = 100 g/L, ANC = 1.5 x 109/L, platelets = 100 x 109/L
- •9.Adequate renal and hepatic functions: creatinine clearance >50 cc/min, total bilirubin = 1.5 times ULN, ASAT and ALAT = 3 times ULN (ASAT and ALAT = 5 times ULN in case of liver metastases)
- •10.INR =1.5 times ULN, unless receiving therapeutic anticoagulation
- •11.Negative pregnancy test for females of child-producing potential
- •12.Written informed consent given
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1.Tumours other than colorectal adenocarcinomas (within the previous 5 years) except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix
- •2.Evidence of central nervous system metastases
- •3.Unresolved bowel obstruction or sub-obstruction, uncontrolled Crohn’s disease or ulcerative colitis
- •4.History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure, myocardial infarction or unstable angina in the past six (6) months prior to Day 1 of treatment and serious arrhythmias requiring medication for treatment
- •5.Prolonged QTC interval >450 msec
- •6.Known history of stroke or cerebrovascular accident in the past six (6) months
- •7.Severe diarrhoea
- •8.Chronic infection or uncontrolled serious illness causing immunodeficiency
- •9.Any uncontrolled serious illness or medical condition
- •10.Received mangafodipir at any time
- •11.Welders, mine workers or other workers in occupations (current or past) where high manganese exposure is likely
- •12.Pre-existing neurodegenerative disease (Parkinson’s, Alzheimer’s, Huntington’s etc.) or neuromuscular disorder (Multiple sclerosis, Amyotrophic lateral sclerosis, Polio, hereditary neuromuscular disease)
- •13.Major psychiatric disorder (major depression, psychosis)
- •14.Participation in another clinical study with an investigational medicinal product within 1 month prior to inclusion.
- •15. Blood manganese concentration values >18,3 µg/L at screening
研究者
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尚未招募
Unknown
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