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FILGRASTIM SD/01 PTS W/ NON SMALL CELL LUNG CANCER OR THORACIC TUMORS

FILGRASTIM SD/01 PTS W/ NON SMALL CELL LUNG CANCER OR THORACIC TUMORS
FILGRASTIM SD/01 PTS 治疗非小细胞肺癌或胸部肿瘤
批准号：
6304629
负责人：
CHANDRA BELANI
金额：
$0.3万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
项目状态：
已结题
起止时间：
1999-12-01 至 2000-11-30
来源：
https://reporter.nih.gov/project-details/6304629
关键词：
cis platinum compound clinical research clinical trial phase I colony stimulating factor drug interactions drug screening /evaluation hematopoietic stem cells human subject human therapy evaluation neoplasm /cancer chemotherapy neoplasm /cancer immunotherapy neutrophil nonsmall cell lung cancer paclitaxel pharmacokinetics thorax neoplasm

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中文摘要
翻译
本研究的具体目的是比较非小细胞肺癌患者在血液学稳定状态下应用FilgrTim-SD/01的安全性；比较化疗前FilgrTim-SD/01和FilgrTim的药代动力学(PK)；以及通过外周血中中性粒细胞绝对计数(ANC)和造血祖细胞水平的变化来比较FilgrTim-SD/01的药效学(PD)反应。这是一项在非小细胞肺癌患者(NSCLC)和其他接受卡铂和紫杉醇(紫杉醇)治疗的胸部肿瘤患者中应用非小细胞肺癌患者(NSCLC)和其他胸部肿瘤患者的非小细胞肺癌SD/01的I期开放标签剂量递增研究。
英文摘要
The specific aims of this study are to compare the safety of Filgrastim-SD/01 to Filgrastim administered to non-small cell lung cancer patients in hematologic steady state; and to compare the pharmacokinetics (PK) of Filgrastim-SD/01 to Filgrastim pre-chemotherapy; and to compare the pharmacodynamic (PD) responses to Filgrastim-SD/01 to Filgrastim as measured by changes in absolute neutrophil count (ANC), and hematopoietic progenitor cell levels in the peripheral blood. This is a phase I open label, dose escalation study of filgrastim SD/01 in non-small cell lung cancer patients (NSCLC) and patients with other thoracic tumors treated with carboplatin and paclitaxel (Taxol).
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