ACTRN12609000392268已完成3 期
Study VEG108844, a Study of Pazopanib versus Sunitinib in the Treatment of Subjects with Locally Advanced and/or Metastatic Renal Cell Carcinoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 876
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Written informed consent
- •Diagnosis of renal cell carcinoma with clear-cell component histology.
- •Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mammalian target of Rapamycin (mTOR) inhibitor, sunitinib, sorafenib or other Vascular endothelial growth factor (VEGF) Tyrosine Kinase Inhibitor (TKI) for advanced or metastatic Renal Cell Carcinoma (RCC)
- •Locally advanced or metastatic renal cell carcinoma
- •Measurable disease by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
- •Karnofsky performance scale status of
- •Age greater than or equal to 18 years
- •A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception.
- •Adequate organ system function
- •Total serum calcium concentration less than 12.0mg/dL
- •Left ventricular ejection fraction greater than or equal to lower limit of institutional normal.
排除标准
- •Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)
- •History of another malignancy (unless have been disease-free for 3 years)
- •History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for greater than or equal to 6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)
- •Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- •Presence of uncontrolled infection.
- •Prolongation of corrected QT interval (QTc) greater than 480 milliseconds
- •History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association
- •History of cerebrovascular accident including transient ischemic attack
- •History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless had recent DVT and have been treated with therapeutic anti-coagulating agents for at least 6 weeks)
- •Poorly controlled hypertension (defined as systolic blood pressure of greater than or equal to 150mmHg or diastolic blood pressure of greater than or equal to 90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
- •Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- •Evidence of active bleeding or bleeding susceptibility
- •Spitting up blood within 6 weeks of first dose of study drug
- •Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study.
- •Use any prohibited medications within 14 days of the first dose of study medication.
- •Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
研究者
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