NCT01473043No Longer Available不适用
Clinical Study With Axitinib (AG 013736) In Patients With Metastatic Renal Cell Carcinoma After Failure Of One Prior Systemic First-Line Therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- Pfizer
- 试验地点
- 1
研究概览
简要总结
This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. The study will recruit a maximum of 30 patients from 2 countries including Australia and Canada. Patients will be followed up for efficacy, safety and health related outcomes.
研究设计
- 研究类型
- Expanded Access
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
- •Metastatic renal cell carcinoma with a component of clear cell subtype.
- •Prior first line systemic therapy
- •At least 1 measurable lesion as per Response Evaluation Criterion in Solid Tumors [RECIST 1.1].
- •Adequate hematology, liver and kidney functions
- •Eastern Cooperative Oncology Group [ECOG] performance status of 0 or
- •Life expectancy of ≥12 weeks.
- •Normotensive or well controlled hypertension (less than/equal to 140/90 mm Hg.)
- •Negative pregnancy test
- •Adequate recovery time from prior systemic therapy, surgery or radiation
- •Willing and able subjects who have signed consent
排除标准
- •More than one prior systemic therapy regimen
- •Major bowel-penetrating surgery <4 weeks
- •Active gastro intestinal bleed in past 3 months
- •Active peptic ulcer disease in the past 6 months
- •Current or anticipated use of potent CYP3A4/5 inhibitors
- •Current or anticipated use of known CYP3A4/5 or CYP1A2 inducers
- •Requirement for therapeutic warfarin or high dose steroids
- •Symptomatic or untreated brain metastases
- •A serious uncontrolled medical disorder or active infection
- •Pregnant or breastfeeding females
- •History of another active malignancy
研究者
研究点 (1)
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