NCT01031875已完成2 期
Phase 2 Study With the Multi-Targeted Tyrosine-Kinase Inhibitor Pazopanib (GW786034) for Patients With Relapsed or Refractory Urothelial Cancer
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2009年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Response rate (complete and partial response) according to RECIST 1.1 criteria
研究概览
简要总结
RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating patients with or metastatic urothelial cancer or bladder cancer that has relapsed or not responded to treatment.
详细描述
OBJECTIVES:
Primary
- To evaluate the activity of daily oral doses of pazopanib hydrochloride monotherapy in patients with relapsed/refractory metastatic urothelial carcinoma or transitional cell tumors.
Secondary
- To evaluate the safety and tolerability of pazopanib hydrochloride monotherapy in a population of chemotherapy pretreated patients.
- To assess progression-free survival of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diagnosis of transitional cell tumors of the bladder or the urothelium
- •Metastatic disease
- •Relapsed or refractory disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan
- •Must have failed ≥ 1 cisplatin-based conventional chemotherapy regimen for metastatic disease (neoadjuvant/adjuvant therapy excluded)
- •No history or clinical evidence of CNS metastases or leptomeningeal carcinomatosis, except for individuals who were previously treated for CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for the past 6 months
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Life expectancy ≥ 12 weeks
- •Hemoglobin ≥ 9.0 g/dL
- •Absolute neutrophil count ≥ 1,000/μL
- •Platelet count ≥ 75,000/μL
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)
- •Alkaline phosphatase ≤ 4 x ULN
- •Serum creatinine ≤ 1.5 mg/dL
- •PT-INR/PTT < 1.5 x ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after completion of study therapy
- •Able to swallow oral medication
- •None of the following cardiovascular conditions within the past 6 months:
- •Cardiac angioplasty or stenting
- •Myocardial infarction
- •Unstable angina
- •Symptomatic peripheral vascular disease
- •NYHA class III or IV congestive heart failure
- •Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted)
- •Uncontrolled hypertension
- •No history of HIV infection or active chronic hepatitis B or C
- •No active clinically serious infections > grade 2 NCI-CTC version 4.0
- •No seizure disorder requiring medication (e.g., steroids or anti-epileptics)
- •No history of any of the following conditions within the past 6 months:
- •Cerebrovascular accident
- •Pulmonary embolism
- •Untreated deep venous thrombosis
- •No evidence or history of bleeding diathesis
- •No known endobronchial lesions or involvement of large pulmonary vessels by tumor
- •No hemoptysis within the past 6 weeks
- •No gastrointestinal abnormalities that may increase the risk of GI bleeding or affect the absorption of investigational study drug
- •No other cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, or any cancer curatively treated > 5 years prior to study entry
- •No substance abuse, medical, psychological, or social conditions that may interfere with the study participation or evaluation of the study results
- •No concurrent unstable condition that could jeopardize patient safety and their compliance in the study
- •No non-healing wound, fracture, or ulcer within the past 28 days
- •No major trauma within the past 28 days
- •No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib hydrochloride
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from all prior therapy
- 另有 11 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate (complete and partial response) according to RECIST 1.1 criteria
次要结局
- Safety and tolerability, in terms of incidence, nature, and severity of treatment-related adverse events according to CTCAE v4.0
- Progression-free survival
研究者
研究点 (2)
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