NCT00866528已完成1 期
An Open-label, Multicenter, Phase I/II Study of Pazopanib in Combination With Paclitaxel in First-line Treatment of Subjects With Stage IIIBwet/IV Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Phase I: safety and tolerability (Serious adverse events, adverse events, dose-limiting toxicities, clinical laboratory data, vital signs, ECG, ECOG performance status)
研究概览
简要总结
The Phase I part of the study will identify the doses of pazopanib and paclitaxel that can be administered safely in combination. The Phase II part of the study will not be progressed as documented in Protocol Amendment 01.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Written informed consent
- •At least 18 years old
- •Histologically- or cytologically-confirmed diagnosis of Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC (or for Phase I only, advanced solid tumor for which there is no standard therapy or for whom paclitaxel is standard therapy).
- •No prior systemic first-line therapy for advanced disease
- •Measurable disease
- •ECOG performance status of 0 or 1
- •Life expectancy of at least 12 weeks.
- •Able to swallow and retain oral medication
- •Adequate organ system function (hematological, renal, and hepatic)
- •Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception
排除标准
- •Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC (or for Phase I, other than the primary solid tumor)
- •CNS metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
- •Clinically significant gastrointestinal abnormalities
- •Prolongation of corrected QT interval (QTc) > 480 msecs
- •History of any one or more cardiovascular conditions within the past 6 months prior to randomization
- •Poorly controlled hypertension
- •History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- •Major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer
- •Evidence of active bleeding or bleeding diathesis
- •Recent hemoptysis
- •Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- •Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
- •Use of any prohibited medication
- •Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
- •Ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity except alopecia
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, paclitaxel, and/or carboplatin.
研究组 & 干预措施
Phase I
Experimental
oral pazopanib once daily (Phase I starting dose 800 mg) and paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).
干预措施: pazopanib (Drug)
Phase I
Experimental
oral pazopanib once daily (Phase I starting dose 800 mg) and paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).
干预措施: paclitaxel (Drug)
结局指标
主要结局
Phase I: safety and tolerability (Serious adverse events, adverse events, dose-limiting toxicities, clinical laboratory data, vital signs, ECG, ECOG performance status)
时间窗: at least one cycle of treatment (3 weeks)
次要结局
- Phase I: paclitaxel and pazopanib pharmacokinetics(Cycle 1 and Cycle 2 PK sampling)
- Phase I: clinical activity(at least 6 weeks)
研究者
研究点 (1)
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