Pharmacokinetic Study of CPT-11, Raltegravir and Midazolam With Characterisation of UGT1A1 Genotype
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11) and its metabolite SN-38
研究概览
简要总结
The objectives of this study are:
To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11) and its metabolite SN-38.
To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan and raltegravir pharmacokinetic parameters.
To model pharmacokinetic and pharmacodynamic behaviour of CPT-11 in the study population.
详细描述
To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11) and its metabolite SN-38.
To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan and raltegravir pharmacokinetic parameters.
To model pharmacokinetic and pharmacodynamic behaviour of CPT-11 in the study population.
VI. Abstract of Research Proposal In no more than 300 words, describe concisely the specific aims, hypotheses, methodology and approach of the application, indicating where appropriate the application's importance to science or medicine. The abstract must be self-contained so that it can serve as a succinct and accurate description of the application when separated from it. Please use lay terms. If this not possible, the technical and medical terms should be explained in simple language. The pharmacokinetic parameters of raltegravir will correlate well with irinotecan (CPT-11) and its metabolite SN-38 and better than midazolam.
Raltegravir pharmacokinetic parameters can be used to predict the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan. Patients who are prescribed the CPT-11 containing regimen FOLFIRI will be selected for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven solid tumour for which CPT-11 given by the Folfiri regimen is indicated and prescribed by the attending physician.
- •Age above 21 years.
- •Measurable or evaluable disease
- •Karnofsky performance status > 70%
- •Life expectancy > 3 months
- •WBC > 3.0 x 103/?l; ANC > 1500/?l
- •Hemoglobin > 9.0 g/dl
- •Platelets > 100000/?l
- •Creatinine < 1.5 x ULN or calculated creatinine clearance > 40 ml/min
- •Total bilirubin < 1.5 x ULN
- •SGOT, SGPT < 5 x ULN unless due to disease
排除标准
- •Biologic therapy or chemotherapy within 4 weeks. (Six weeks for prior nitrosoureas or mitomycin C).
- •Radiation therapy within 4 weeks if > 25% of bone marrow was irradiated.
- •Have not received any medications that are known to be metabolised by UGT1A1 within 30 days of the first dose of CPT-
- •Short gut syndrome or other causes of malabsorption.
- •Colony stimulating factors within 2 weeks.
- •Women of childbearing potential not practicing birth control. (Note: by means other than oral contraception)
- •Pregnant women
- •Severe peripheral neuropathy grade 2 or higher.
- •Medical or psychiatric conditions which may impair the patient's ability to provide informed consent.
- •Hypersensitivity to CPT-11, raltegravir or midazolam/other benzodiazepines.
- •Rapidly progressive intracranial or spinal metastatic disease.
研究组 & 干预措施
CPT-11
干预措施: CPT-11, Raltegravir (Isentress®), Midazolam (Drug)
结局指标
主要结局
Correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11) and its metabolite SN-38
时间窗: 1 year
次要结局
未报告次要终点