NCT00083525已完成1 期
Urokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, and pharmacodynamics of the combination of WX-UK1 and capecitabine in patients with advanced malignancies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of a non-hematologic malignancy that is either unresponsive to currently available therapies or for which there is no known effective therapy.
- •Patient willing to give informed consent, understand and comply with study procedures/restrictions
- •Patients must have an ECOG performance status of 0, 1, or 2
- •Life expectancy of > 12 weeks
- •Negative serum pregnancy test for women of child-bearing potential and not nursing. Fertile patients must use effective contraception during and for 30 days (women) or 4 months (men) after treatment with WX-UK
- •Measurable or non-measurable disease. Patients without clinical or radiologic evidence of disease are not eligible.
- •Laboratory parameters (obtained within the screening period): WBC >= 3 G/L, neutrophils >= 1.5 G/L, platelets >= 100 G/L, Hgb >= 9 g/dL), total bilirubin <= 1.5 x ULN, ASAT/ALAT/AP/GGT <= 2.5 x ULN, serum creatinine <= 2 x ULN.
排除标准
- •History of hypersensitivity to the study drugs or chemically related compounds or any of the excipients
- •History of or current neurological disorder, in particular an active or treated seizure disorder
- •Known standard therapy for the patient's disease that is potentially curative or known to extend life expectancy.
- •Carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease.
- •Concurrent or prior (within 4 weeks prior to start of WX-UK1 treatment for cytotoxic chemotherapy, biological-, endocrine-, investigational- or radiotherapy and 6 weeks for nitrosoureas, mitomycin-C)
- •Uncontrolled infection
- •Significant cardiac disease (NYHA classification III or IV
- •Contraindication to an infusion volume of 1000 ml over 2 h
- •History of or current blood coagulation disorders
- •History of or current bleeding disorder (including cerebral bleeding, recurrent massive nose bleeds, hematuria or unexplained bruising)
- •Diabetes mellitus, if not controlled by insulin, oral anti-diabetic agents or diet alone
- •Anticoagulant or thrombolytic therapy within four weeks prior to start of treatment (except heparin flush to keep a port open or coumadin 1 mg/day or ASA 100mg/d)
- •Active serious illness that renders the patient unsuitable for study entry or multiple blood sampling
- •Illness or condition that might alter the absorption, distribution, metabolism and elimination of WX-UK1
- •Known Hepatitis B/C or HIV infection
- •Contraindication to capecitabine intake as specified in the SPC such as DPD-deficiency or concomitant intake of sorivudine or sorivudine related compounds
- •Known hemorrhagic brain metastasis
研究者
研究点 (2)
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