EUCTR2005-004078-25-AT进行中（未招募）不适用
A Randomized, Double-blind, Placebo-controlled, Multi-centre Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients with Locally Advanced and/or Metastatic Renal Cell Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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. Diagnosis of clear cell RCC that is predominantly clear cell histology.
- •2. Locally advanced RCC (defined as disease not amenable to curative surgery or radiation therapy) or metastatic RCC (equivalent to stage IV RCC according to AJCC staging.
- •3. Must have measurable disease, i.e. presenting with at least one measurable lesion per RECIST. A measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter >20 mm using conventional techniques, or >10 mm with spiral CT scan.
- •4. Must have received a first-line cytokine-based systemic treatment for locally advanced or metastatic RCC with documented disease progression or documented treatment discontinuation due to unacceptable toxicity.
- •Note: The first-line cytokine-based treatment can be interleukin-2 (IL-2) or interferon-alpha (INF-alpha) monotherapy, IL-2 in combination with INF-alpha, IL-2 and/or INF-alpha in combination with chemotherapy or hormonal therapy.
- •Note: Prior adjuvant or neo-adjuvant therapies are permitted excluding any agents that target VEGF or VEGF receptors. The adjuvant/neo-adjuvant therapies should not be considered as first-line systemic treatment for advanced RCC.
- •Exception 1: Patients who live in countries or regions where cytokine therapy is not approved or where there are barriers to the access of such therapies are eligible to participate without receiving a first-line cytokine-based systemic treatment for locally advanced or metastatic RCC.
- •Exception 2: Patients who live in countries or regions where IL-2 or INF-? has been approved for the treatment of advanced/metastatic RCC, however, these agents are generally not recognized by the local clinical community as a standard treatment for advanced/metastatic RCC, or where the physician and the patient have determined that the available cytokine therapies are not an acceptable therapeutic option.
- •Exception 3: Patients who have recurred following prior adjuvant or neo-adjuvant cytokine therapy for RCC are eligible to participate without receiving a first-line systemic treatment for locally advanced or metastatic RCC. These patients should be stratified as the first-line population (See section 4 of the protocol).
- •5. Male or female >=18 years of age
- •6. ECOG PS 0 or 1
- •7. Adequate baseline organ function as defined in the protocol
- •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. History of another malignancy.
- •2. History or presence of central nervous system (CNS) metastasis or leptomeningeal tumors as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam.
- •3. Presence of uncontrolled infection.
- •4. History of Class III or IV congestive heart failure according to New York Heart Association (NYHA) classification [See 14.5 Appendix 5 of protocol for description].
- •5. Current or prior use of an investigational anti-cancer drug within 4 weeks of start of study.
- •6. Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafinib, etc).
研究者
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