EUCTR2007-005639-26-GB进行中（未招募）1 期
A Multicenter, Double Blind, Placebo controlled, Randomized study of TroVax vs Placebo in the First Line treatment of Patients with Metastatic Colorectal Cancer receiving Chemo-based Therapy. - FLAMENCO
Oxford BioMedica0 个研究点目标入组 1,312 人开始时间: 2008年2月1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
- 1,312
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
入选标准
- •- Patients with histology/cytology confirmed colorectal adenocarcinoma
- •- Metastatic colorectal cancer
- •- No prior palliative chemotherapy
- •- Patient's informed consent obtained, signed and dated.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •* Related to study methodology
- •- Age < 18 years old
- •- ECOG performance status > 2
- •- (Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse.
- •- Treatment with an investigational agent within 4 weeks (6 weeks from immunotherapy) of study enrollment
- •- Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time to randomization
- •- Patients with resectable liver or lung metastasis (study treatment should not be administered with neo-adjuvant intent in case of resectable liver or lung metastases, or with adjuvant intent after surgery of liver or lung metastases)
- •- Known brain metastasis or leptomeningeal disease
- •- History of other neoplasm. Patients with a prior history of either non-metastatic non-melanoma skin cancers, or carcinoma in situ of the cervix, or other cancer cured by surgery, or small field radiation or chemotherapy = 5 years prior to randomization are eligible
- •- Life expectancy < 3 months
- •* Related to chemo-based therapy (biological functions within 8 days before the first cycle: repeat in-range results within the screening period may replace previous out of range results in applying there exclusion criteria)
- •- Absolute neutrophil count (ANC) < 1.5 x 10e9/L, hemoglobin < 8.5 g/dL, platelet < 75 x 10e9/L
- •- Bilirubin = 1.5 x ULN, ASL/ALT or alkaline phosphatase (AP) = 3.0 x ULN, or in case of liver involvement AST/ALT or AP = 5 x ULN
- •- Creatinine > 1.0 x ULN, except in case of creatinine > 1.0 x ULN and = 1.5 x ULN if calculated creatinine clearance = 60 mL/min
- •- Any other active illness such as uncontrolled cardiac disease or hypertension, uncontrolled diabetes that would preclude safe administration of study therapy at the time of randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease or clinically significant arrhythmias (grade 3-4)
- •* Related to TroVax
- •- Lymphocytes < 1 x 10e9/L
- •- Serious infection within 28 days prior to randomization
- •- History of hypersensitivity to vaccinia vaccination
- •- Known hypersensitivity to egg protein or neomycin
- •- Known positive test to human immunodeficiency virus (HIV) or any congenial or acquired immune deficiency, or active and/or requiring treatment hepatitis B or C
- •- Active eczema with lesions on the skin
- •- Prior history of organ transplantation
研究者
相似试验
进行中（未招募）
不适用
A Multicenter, Double Blind, Placebo controlled, Randomized study of TroVax vs Placebo in the First Line treatment of Patients with Metastatic Colorectal Cancer receiving Standard of Care.-----------------------------------------------------------------------------------------------Estudio multicéntrico, doble ciego, controlado con placebo y aleatorizado de TroVax? frente a placebo en el tratamiento de primera línea de pacientes con cáncer colorrectal metastásico que reciben el tratamiento habitual. - FLAMENCOMetastatic Colorectal Adenocarcinoma.-----------------------------------------------Adenocarcinoma Colorectal Metastásico.MedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerEUCTR2007-005639-26-ESOxford BioMedica1,300
进行中（未招募）
不适用
A Multicenter, Double Blind, Placebo controlled, Randomized study of TroVax vs Placebo in the First Line treatment of Patients with Metastatic Colorectal Cancer receiving Chemo-based Therapy. - FLAMENCOMetastatic Colorectal AdenocarcinomaMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerEUCTR2007-005639-26-DEOxford BioMedica (UK) Limited1,312
进行中（未招募）
1 期
A placebo controlled Study of Patiromer for the Management of high potassium serum levels in Subjects Receiving a certain group of medications called Renin-Angiotensin-Aldosterone System Inhibitor for treatment of Heart failure.EUCTR2018-005030-38-ITRelypsa Inc878
进行中（未招募）
不适用
A clinical study, carried out in different centers and using a placebo, to assess the effect of a medicinal product, containing sapropterin as the active substance, on mental abilities in young adults suffering from phenylketonuria, a genetic disease in which an enzyme defect leads to accumulation of a waste product (phenylketone) which can be detected in urine.MedDRA version: 16.0Level: LLTClassification code 10034873Term: Phenylketonuria (PKU)System Organ Class: 100000004850PhenylketonuriaEUCTR2010-024311-13-BEMerck KGaA30
进行中（未招募）
不适用
A clinical study, carried out in different centers and using a placebo, to assess the effect of a medicinal product, containing sapropterin as the active substance, on mental abilities in young adults suffering from phenylketonuria, a genetic disease in which an enzyme defect leads to accumulation of a waste product (phenylketone) which can be detected in urine.PhenylketonuriaEUCTR2010-024311-13-NLMerck KGaA30