EUCTR2007-006459-38-BE进行中（未招募）不适用
CONTINUOUS TREATMENT WITH SUNITINIB IN PATIENTS WITH SYMPTOMATIC PLEURAL AND/OR PERITONEAL MALIGNANT EFFUSIONS. - SUPPER
St Augustinus0 个研究点目标入组 50 人开始时间: 2008年8月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histopathologically confirmed malignancy.
- •2.Histologically or cytopathologically confirmed malignant pleural and/or peritoneal effusions. If both are present in any one patient, malignancy most be documented in at least one site.
- •3.Radiologically documented increase in pleural and/or peritoneal fluid over the past 6 weeks prior to enrollment into this study.
- •4.Disease extent is not amenable to standard therapy with curative intent,
- •5.Have refractory disease or a disease state were systemic options are either non-existant, considered not feasible or not justified, or refused.
- •6.Male or female, 18 years of age or older.
- •7.Resolution of all acute toxic effects of prior systemic therapy, radiotherapy or surgical procedure to NCI CTCAE Version 3.0 grade =1. Prior therapy with taxanes is allowed, but last administration must have dated at least 6 weeks prior to enrollment in this study.
- •8.Adequate organ function as defined by the following criteria:
- •.• Total serum bilirubin =2 x ULN
- •.• Serum transaminases <5 x ULN
- •.• Serum creatinine =2 x ULN
- •.• Absolute neutrophil count (ANC) =1000/mL without G-CSF)
- •.• Platelets =75,000/mL
- •.• Hemoglobin =8.0 g/dL
- •9.Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
- •10.Willingness and ability to comply with scheduled visits & study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Current treatment in another therapeutic clinical trial.
- •2.Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication.
- •3.Previous treatment with any anti-VEGF or anti-PDGF agent, or any other TKI.
- •4.Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator. Male patients must be surgically sterile or agree to use effective contraception.
- •5.Normal gastro-intestinal function, excluding patient subobstruction.
- •6.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •7.Patients for whom obvious other treatment modalities for the underlying malignancy exist.
研究者
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