EUCTR2018-003074-27-ES进行中（未招募）1 期
A Randomized, Multicentre, Open-Label Controlled Phase II Trial of Foxy-5 as Neo-Adjuvant Therapy in Subjects with Wnt-5a Low Colon Cancer.
WntResearch0 个研究点目标入组 180 人开始时间: 2018年10月11日最近更新:
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
入选标准
- •1.Ability to understand and willingness to provide written informed consent before any trial-related activities.
- •2.Age = 18 years.
- •3.Male or female subjects with adenocarcinoma of the colon, judged by CT or MRI as either one of the following stages per TNM classification of colon cancer (8th edition, 2017): T1-4, N1-2, M0 or T4, N0, M0 and who are considered to fulfil the local criteria for adjuvant post-operative chemotherapy after scheduled surgery.
- •4.Scheduling of surgery according to local practice allows at least 9 pre-surgery administrations of Foxy-5 for the subject. (Please note: surgery should not be postponed for trial treatments).
- •5.Sexually active women of childbearing potential (WOCBP) and males with WOCBP partners who are randomized to the Foxy-5 Arm must use a highly effective method of contraception for the treatment duration and for 28 days after last Foxy-5.
- •6.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •7.Clinical laboratory values at screening:
- •a.Absolute neutrophil count =1.5 x 109/L
- •b.Haemoglobin = 9 g/dL
- •c.Platelets = 100 x 109/L
- •d.Aspartate Transaminase (AST) and Alanine Transaminase (ALT) =1.5x Upper Limit of Normal (ULN)
- •e.Serum bilirubin =1.5 x the ULN
- •f.Creatinine clearance >60 mL/min (determined by Cockcroft-Gault Equation).
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1.Assessed as not suitable or unable to tolerate adjuvant chemotherapy.
- •2.Evidence of distant metastatic (M1) disease at Screening (N1-2 is allowed).
- •3.Any surgery (except tumour biopsy) or therapy with immune suppressive agents or bone marrow stimulating factors within the last two weeks prior to randomization.
- •4.Any active infection requiring IV antibiotic treatment at the time of screening.
- •5.History of hematologic or primary solid tumour malignancy. Subjects in complete remission for at least 5 years or judged as cured by the Investigator may be included. Subjects with any prior non-invasive basal and squamous skin cell carcinoma, cervical carcinoma of Stage 1B or less, and non-invasive superficial bladder cancer may be included.
- •6.Pregnant or breastfeeding women.
- •7.Currently participating in another trial and receiving trial therapy or received investigational therapy within 4 weeks of the first dose of Foxy-5.
- •8.Any other condition or treatment that, in the opinion of the Investigator, might interfere with the trial or current drug or substance abuse.
- •9.Inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial.
- •10.Unlikely to comply with the protocol requirements, instructions and trial-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial
- •11.Legal incapacity or limited legal capacity.
- •12.Any condition, which results in an undue risk for the subject during the trial participation according to the Investigator.
研究者
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