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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

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中文摘要
翻译
本研究的具体目的是比较非格司亭-SD/01与非格司亭在血液学稳态非小细胞肺癌患者中给药的安全性;并比较非格司亭-SD/01与非格司亭化疗前的药代动力学(PK);并比较非格司亭-SD/01与非格司亭的药效学(PD)反应(通过中性粒细胞绝对计数(ANC)的变化测量),和外周血中的造血祖细胞水平。 这是一项非格司亭SD/01在接受卡铂和紫杉醇(泰素)治疗的非小细胞肺癌(NSCLC)患者和其他胸部肿瘤患者中的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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CLINICAL TRIAL: PI &PHARMACOKINETIC SINGLE AGENT STUDY OF DRUG IN PTS W ADV MALI
Phase I Clinical Trials of Novel Anticancer Agents
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