NCT00871403已完成2 期
An Open-label, Multicentre, Randomised Phase II Study of Pazopanib in Combination With Pemetrexed in First-line Treatment of Subjects With Predominantly Non-squamous Cell 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
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 predominantly nonsquamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC
- •No prior systemic first-line therapy for advanced NSCLC
- •Measurable disease
- •Eastern Cooperative Oncology Group (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, hepatic, and renal)
- •Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception. A male with a female partner of childbearing potential is eligible if he uses a barrier method of contraception or abstinence during the study
排除标准
- •Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC
- •Central nervous system (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, pemetrexed, and/or cisplatin
- •Inability to interrupt aspirin or other non-steroidal anti-inflammatory drugs during the study
- •Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone
- •Clinically significant third-space fluid collections (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study start
- •Recent or concurrent yellow fever vaccination
研究组 & 干预措施
Arm 1
Experimental
Investigational treatment (pazopanib and pemetrexed)
干预措施: pazopanib and pemetrexed (Drug)
Arm 2
Active Comparator
Standard treatment (pemetrexed and cisplatin)
干预措施: pemetrexed and cisplatin (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Randomization until progression or death (up to 85 weeks)
PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion).
次要结局
- Percentage of Participants With a Complete Response or a Partial Response(Randomization until response or progressive disease (up to 85 weeks))
- Overall Survival (OS)(Randomization until death (up to 85 weeks))
- Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only(Randomization until response or progressive disease (up to 85 weeks))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast CancerNeoplasms, BreastNCT00347919GlaxoSmithKline189
已完成
2 期
Pazopanib Plus Lapatinib Compared to Lapatinib Alone and Pazopanib Alone In Subjects With Metastatic Cervical CancerNeoplasms, Uterine CervixMetastatic Cervical CancerNCT00430781GlaxoSmithKline228
已完成
2 期
Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Participants With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With ChemotherapyNon-small Cell Lung CancerNCT00533429Eli Lilly and Company40
已完成
2 期
Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT00269152Eli Lilly and Company122
终止
1 期
Pazopanib or Pemetrexed and Crizotinib in Advanced CancerAdvanced CancersNCT01548144M.D. Anderson Cancer Center178