ISRCTN81098537已完成不适用
An open-label single centre dose-escalating phase I trial of oral artesunate in patients with metastasized cervix carcinoma
Dafra Pharma Research and Development (Belgium)0 个研究点目标入组 15 人开始时间: 2010年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- 性别
- Female
入选标准
- •1. Females aged 18 years or above
- •2. Diagnosed with cervix carcinoma stages IIIb, IVa and IVb
- •3. Overall good general condition (Eastern Cooperative Oncology Group [ECOG] performance status less than or equal to 2)
- •4. Written informed consent
排除标准
- •1. Contraindication to use of artesunate due to hypersensitivity
- •2. Pregnant at time of recruitment
- •3. Human immunodeficiency virus (HIV) positive
- •4. History of hearing or balance problems
- •5. Weight of less than 50 kg or greater than 100 kg
- •6. On concomitant medication known to interact with artesunate
- •7. The following laboratory values obtained within 14 days prior to recruitment:
- •7.1. Absolute neutrophil count (ANC) less than 1,000 cells/mm3
- •7.2. Haemoglobin lower than 9.0 g/dL
- •7.3. Platelet count less than 100,000/mm3
- •7.4. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]), and alkaline phosphatase higher than 5 x upper limit of normal (ULN)
- •7.5. Total bilirubin higher than 1.5 x
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