ACTRN12619000192189招募中1 期
Reducing Oxaliplatin Neurotoxicity: A Phase IB Randomized, Double-Blind, Placebo-Controlled, Crossover, Dose-Finding and Proof-of-Concept Trial of Cimetidine in Gastrointestinal Cancer Patients
niversity of Auckland0 个研究点目标入组 60 人开始时间: 2019年2月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Histologically proven advanced-stage gastrointestinal cancer
- •Scheduled to undergo standard palliative-intent oxaliplatin-based chemotherapy
- •Age>18 years
- •Written informed consent
排除标准
- •Early- or locally advanced-stage gastrointestinal cancer for curative-intent oxaliplatin-based therapy in the adjuvant, neoadjuvant, chemoradiation or other settings
- •Prior exposure to oxaliplatin or other neurotoxic chemotherapies including by not limited cisplatin, vincristine, vinorelbine, docetaxel or paclitaxel.
- •Pregnant or nursing women
- •Any concomitant medications recommended to avoid with cimetidine or oxaliplatin
- •Creatinine clearance less than or equal to 50ml/min
- •Total bilirubin greater than 1.5*ULN
- •AST or ALT greater than 3.0*ULN or greater than 5.0*ULN if due to liver metastases
- •Pre-existing peripheral neuropathy greater than Grade 1
- •Contraindications to EMG
- •Contraindications to repeated pharmacokinetic blood sampling
研究者
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