NL-OMON45868撤回2 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. - NeoFox
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 24
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
- 年龄范围
- 18 至 99（—）
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
- •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 purposes).
- •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).
排除标准
- •Candidates will be excluded from trial entry if any of the following exclusion criteria is met:
- •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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