Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
Randomized, Double-blinded, Placebo-controlled Phase II Study of Vandetanib (ZactimaTM) Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Republic of Korea
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CheongJu、Republic of Korea、大韩民国
- Research Site
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Gyeonggi-do、Republic of Korea、大韩民国
- Research Site
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Gyeongsangnam-Do、Republic of Korea、大韩民国
- Research Site
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Incheon、Republic of Korea、大韩民国
- Research Site
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Seoul、Republic of Korea、大韩民国
- Research Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIb-IV) at the time of original diagnosis.
- Completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m^2/day on day 1 and 8) and cisplatin (70-80mg/m^2/day on day 1) every 3 weeks and have shown response, Complete Response(CR), Partial Response (PR) or stable disease (SD) by RECIST.
- WHO PS 0-1
- No prior radiotherapy to chest, immunotherapy or biologic therapy
Exclusion Criteria:
- Mixed small cell and non small-cell lung cancer history.
- Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab [Erbitux] or bevacizumab [Avastin] is not permitted.)
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
- Radiation therapy within 4 weeks before the start of study therapy. Major surgery within 4 weeks, or incomplete healed surgical incision before starting study therapy.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂
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安慰剂
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实验性的:Vandetanib
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Tablet, oral, daily
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Progression-free Survival (PFS) Rate at 3 Months
大体时间:12 weeks
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Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Progression-free Survival (PFS)
大体时间:Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
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Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.
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Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
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Overall Survival (OS)
大体时间:Every 12 weeks unless the patient withdraws consent
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Overall survival (OS) defined as the median time from randomization to death from any cause.
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Every 12 weeks unless the patient withdraws consent
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Disease of Response (DOR)
大体时间:Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
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Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response |
Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
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Objective Response Rate (ORR)
大体时间:Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
|
Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response. |
Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
非小细胞肺癌的临床试验
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Centre Oscar LambretUniversity Hospital, Lille终止
-
Spanish Lung Cancer Group完全的
-
Jiangsu Aosaikang Pharmaceutical Co., Ltd.完全的
-
Jiangsu Aosaikang Pharmaceutical Co., Ltd.完全的
-
Niguarda HospitalUniversity of Turin, Italy; Fondazione del Piemonte per l'Oncologia完全的
-
AstraZeneca完全的局部晚期或转移性 EGFR(+) NSCLC 患者中国
-
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安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的