NCT00091299已完成1 期
An Open Label, Non Randomized , One Sequence, Add-On Study to Investigate the Effects of PTK787/ZK 222584 on the Pharmacokinetics and Pharmacodynamics of Warfarin at Steady-States in Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate acute and chronic changes in INR when Warfarin is co-administered with PTK787/ZK 222584
研究概览
简要总结
RATIONALE: Vatalanib may stop the growth of tumor cells by stopping blood flow to the tumor. Warfarin may be effective in preventing the formation of blood clots in patients who are undergoing treatment for advanced solid tumors.
PURPOSE: This phase I trial is studying how well giving warfarin together with vatalanib works in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the acute and chronic changes in INR in patients with advanced solid tumors treated with low-dose warfarin and vatalanib.
Secondary
- Determine the steady-state pharmacokinetics of this regimen in these patients.
- Determine the safety and tolerability of this regimen in these patients.
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
- •Histologically confirmed advanced solid tumor
- •Progressed despite standard therapy OR no known standard therapy exists
- •- Currently receiving OR a candidate for prophylactic low-dose warfarin (1 mg/day)
- •INR ≤ 1.4
- •Must be an extensive metabolizer of CYP2C9 (at least 1 wild type allelle: *1)
- •18 and over
- •Hemoglobin ≥ 9 g/dL
- •AST and ALT ≤ 3 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Albumin ≥ 3.0 g/dL
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine ≤ 1.5 ULN OR
- •Creatinine clearance > 50 mL/min
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •More than 14 days since prior anticancer chemotherapy
- •More than 14 days since prior anticancer hormonal therapy
- •More than 14 days since prior anticancer radiotherapy
- •More than 14 days since other prior anticancer therapy
- •More than 30 days since prior investigational drugs
- •No ethanol for 2 days prior to and for the first 17 days of study treatment
排除标准
- •No poor metabolizers of CYP2C9 (2 alleles of either *2 or *3)
- •brain metastases
- •history of or active coagulation disorders
- •significant risk for bleeding
- •uncontrolled high blood pressure (BP), defined as diastolic BP > 90 mm Hg or systolic BP > 140 mm Hg
- •history of cerebral or aortic aneurysm
- •pregnant or nursing
- •recent history or evidence of drug or alcohol abuse
- •active peptic ulcer disease or gastrointestinal bleeding
- •contraindication or allergy to warfarin or related compounds
- •risk for adverse events related to prolonged PT/PTT due to warfarin administration
- •other medical condition that would preclude study participation
- •concurrent chemotherapy
- •concurrent hormonal therapy
- •concurrent radiotherapy
- •other concurrent CYP2C9 substrates or inhibitors
- •concurrent CYP3A4 inducers or inhibitors
- •concurrent food or dietary supplement known to alter the metabolism of CYP3A4 (e.g., grapefruit or Hypericum perforatum [St. John's wort])
研究组 & 干预措施
warfarin
Experimental
干预措施: warfarin (Drug)
结局指标
主要结局
To evaluate acute and chronic changes in INR when Warfarin is co-administered with PTK787/ZK 222584
时间窗: 2 weeks
次要结局
- To evaluate the steady state pharmacokinetics of (R) and (S) Warfarin when co-administered with PTK787/ZK 222584(2 weeks)
- Safety of low dose warfarin when co-administered with PTK787/ZK 222584(2 weeks)
研究者
研究点 (1)
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