EUCTR2005-004502-82-GB进行中（未招募）1 期
A Phase II Study of Neoadjuvant Sunitinib in Metastatic Renal Cell Carcinoma - NeoSun
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge0 个研究点目标入组 16 人开始时间: 2009年8月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
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
入选标准
- •Presumed metastatic (Stage IV) renal cell carcinoma, as defined by the referring clinician
- •Clinically fit and scheduled for nephrectomy
- •No prior systemic therapy for renal cell carcinoma
- •Male or female, 18 years of age or older
- •Life expectancy of 12 weeks or greater
- •ECOG performance status 0 or 1
- •Radiologically documented, RECIST measurable, metastatic disease. Measurable disease, defined by the presence of at least one lesion outside of the kidney which can be measured in at least one dimension with the longest diameter = 20mm using chest X-ray, = 10mm calliper measurement by clinical exam or = 10mm using spiral CT.
- •Laboratory parameters as follows:
- •oSerum aspartate transaminase (AST) or serum alanine transaminase (ALT) =2.5 x upper limit of normal (ULN), or AST or ALT =5 x ULN if liver function abnormalities are due to underlying malignancy
- •oTotal serum bilirubin =1.5 x ULN
- •oAbsolute neutrophil count (ANC) =1.5 x 10^9/L
- •oPlatelets =100 x 10^9/L
- •oHaemoglobin =90 g/L (However where a transfusion is scheduled the patient may have a lower a value but this must be discussed and approved)
- •oSerum creatinine =1.5 x ULN
- •oProthrombin time (PT) =1.5 x ULN
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •Before patient registration, written informed consent, including for preoperative biopsy, must be given according to ICH/GCP, national and local regulations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Presence of = grade 3 (NCI CTCAE grading version 3.0) haemorrhage within 4 weeks of registration.
- •Any previous chemotherapy or investigational treatment given for renal carcinoma.
- •Diagnosis of any other malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
- •Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
- •Any major surgery in the previous 4 weeks.
- •Co-administration of CYP3A4 inducer or inhibitor medications that would require an increase or decrease in sunitinib dosage from the study dose of 50 mg o.d.
- •Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- •Ongoing cardiac dysrhythmias of = grade 2 (NCI CTCAE grading version 3.0), atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females
- •Treatment with drugs of dysrhythmic potential is not allowed
- •Concurrent participation in another clinical trial using an investigational medicinal product
- •Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
- •Pregnancy or breastfeeding.
- •Female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy and for 6 months after. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after. Barrier contraception is recommended.
- •Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or in the judgment of the investigator would make it undesirable for the patient to enter the trial.
- •Uncontrolled hypertension. Patients are excluded with current blood pressure of either systolic = 150 or diastolic =90. Patients using anti-hypertensive medication to control blood pressure to these levels are elgible.
研究者
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