临床试验/NCT01023347

NCT01023347已完成2 期

A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer

Samyang Biopharmaceuticals Corporation1 个研究点分布在 1 个国家目标入组 276 人开始时间: 2008年6月最近更新: 2017年5月9日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 276
试验地点: 1
主要终点: response rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer.

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

•Histological or cytological evidence of locally advanced, metastatic or recurrent NSCLC (stage IIIB or Iv)
•At least one measurable lesion(s) by RECIST criteria
•No previous palliative chemotherapy
•Age 18 or higher.
•ECOG PS 0-2
•Life expectancy of at least 3 months.
•Adequate hematologic, hepatic, renal function
•Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul)
•Adequate liver function (≤ Total bilirubin ≤ 1.5 upper normal limit, ≤ AST/ALT x 2.5 upper normal limit, Alkaline phosphatase ≤ 2.5 upper normal limit)
•Adequate renal function (≤ serum creatinine 1.5 mg/dl)
•Written informed consent

排除标准

•No prior chemotherapy for NSCLC
•Patients with malignancies (other than NSCLC), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix.
•Peripheral neuropathy ≥ grade 2 (NCI CTC, version 3.0)
•Clinically significant cardiac disease (medically uncontrollable heart disease)
•Active infection or other serious medical illness
•Contraindication to any drug contained in the chemotherapy regimen
•Pregnant or lactating women were excluded.

研究组 & 干预措施

Paclitaxel (Genexol®) and Cisplatin

Active Comparator

干预措施: Paclitaxel (Genexol®) (Drug)

Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin

Experimental

干预措施: Paclitaxel loaded polymeric micelle (Genexol-PM®) (Drug)

结局指标

主要结局

response rate

时间窗: up to 6 cycles

overall responses are complete response and partial response

次要结局

overall survival(up to 3 years)
progression-free survival(up to 3 years)
toxicity profiles(up to 6 cycles)

研究者

发起方

Samyang Biopharmaceuticals Corporation

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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