Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated With Platinum Based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Bioavailability
研究概览
简要总结
Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle.
详细描述
5-HT3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. Nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of SC and IV granisetron will be prospectively compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients receiving platinum-based chemotherapy
- •adequate bone marrow, hepatic and renal function, respectively defined by: platelets >100000/mm3 and absolute neutrophil count >1500/mm3; bilirubin, AST and ALT <2 times x upper limit of normality; and creatinine <1.5 mg/dl.
- •ECOG performance status <2 and body mass index from 20-28 kg/m2.
排除标准
- •Pregnancy
- •Serious concomitant diseases, in the invesgator´s criteria
研究组 & 干预措施
Granisetron SC-Granisetron IV
Granisetron SC followed by Granisetron IV
干预措施: granisetron (Drug)
结局指标
主要结局
Bioavailability
时间窗: Approximately 6 weeks
次要结局
- Safety(Approximately 6 weeks)
研究者
Jose Luis Perez Gracia
Main investigator
Clinica Universidad de Navarra, Universidad de Navarra