A Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effects of Fluvoxamine on the Pharmacokinetics of ASA404 in Adult Patients With Solid Tumor Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- evaluate the effect of administration of fluvoxamine, a CYP1A2 inhibitor, after 2-cycles of ASA404, on the pharmacokinetics of ASA404
研究概览
简要总结
This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and ASA404. The purpose of the Extension Phase is to provide continued treatment for those patients that have not progressed during the Core Phase and to collect safety data on ASA404 when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin chemotherapy regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients having a histologically-proven and radiologically-confirmed advanced or metastatic solid tumor.
- •WHO Performance Status of 0-
- •A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies.
- •Laboratory values within the ranges, as defined below:
- •ANC ≥ 1.5 X 109 /L
- •Platelets ≥ 100 X 109 /L
- •Hemoglobin ≥ 10 g/dL
- •Serum total bilirubin is within normal range
排除标准
- •Patients having CNS metastasis or evidence of leptomeningeal disease.
- •Patients with any of the following:
- •any clinical or electrocardiographic evidence of cadiac ischemia
- •poorly controlled hypertension
- •family history of unexplained sudden death
- •long QT syndrome
- •history of ventricular fibrillation or torsade de pointes
- •congestive heart failure (NYHA class III or IV)
- •myocardial infarction within 12 months of starting study treatment
- •History of neuroendocrine tumors (e.g. carcinoid tumor, pancreatic islet cell tumor).
- •Significant neurological or psychiatric disorder.
- •Smokers (use of cigarettes within the last 3 months).
- •Concomitant use of drugs that are associated with QTc interval prolongation or have a risk of causing torsade de pointes.
- •Concomitant use of serotonin reuptake inhibitors (SSRIs), 5-hydroxytryptamine (5-HT) receptor agonists or selective serotonin / nor-epinephrine reuptake inhibitors (SNRIs) within 30 days prior to starting study treatment.
- •Concomitant use of somatostain analogues (i.e. octreotide, lanreotide within 30 days prior to starting study treatment.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
ASA404 + Fluvoxamine
ASA404 + Fluvoxamine (Core Phase), ASA404 + either paclitaxel or docetaxel or paclitaxel plus carboplain chemotherapy combination (Extension Phase)
干预措施: Vadimezan™ (Drug)
结局指标
主要结局
evaluate the effect of administration of fluvoxamine, a CYP1A2 inhibitor, after 2-cycles of ASA404, on the pharmacokinetics of ASA404
时间窗: approximately 2 months
次要结局
- evaluate the effect of administration of fluvoxamine on the safety profile (incidence of AEs or SAEs generated) of ASA404(4 months)
- assess the safety (incidence of AEs and SAEs) of ASA404 in combination with paclitaxel, doctaxel or the paclitaxel plus carboplatin chemotherapy regimen in patients with solid tumor malignancies(12 months)