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SAFETY & EFFICACY OF LANREOTIDE (IPSTYL) IN ACROMEGALICS

SAFETY & EFFICACY OF LANREOTIDE (IPSTYL) IN ACROMEGALICS
安全
批准号：
6264604
负责人：
DAVID L KLEINBERG
金额：
$2.1万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6264604
关键词：
acromegaly clinical research drug adverse effect drug screening /evaluation endocrine disorder chemotherapy hormone therapy human subject human therapy evaluation insulinlike growth factor neoplasm /cancer chemotherapy peptide hormone analog skeletal disorder chemotherapy somatostatin somatotropin

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中文摘要
翻译
这项II/III期开放标签试验的主要目的是研究lanreotide （IPSTYL）在恢复生长激素和IGF-1水平方面的安全性和有效性，lanreotide是一种半衰期较长的生长抑素的合成类似物。次要目的是研究IPSTYL在肿瘤反应、症状学、不良事件和生长激素降至接近正常水平的患者比例方面的安全性和有效性。Lancreotide每10-14天注射一次。本研究与802相似，不同之处在于这些患者肢端肥大症不能通过手术治愈。
英文摘要
The primary objective of this Phase II/III open label trial is to investigate the safety and efficacy of lanreotide (IPSTYL), a synthetic analog of somatostatin with a prolonged half-life, in normalizing GH and IGF-1 levels. Secondary objectives are to investigate the safety and efficacy of IPSTYL in terms of tumor response, symptomatology, adverse events and proportion of patients in whom GH have been reduced to near normal levels. Lancreotide is given as a single injection every 10-14 days. This study is similar to 802 except these patients have acromegaly not cured by surgery.
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会议论文
SURGICAL DEBULKING PLUS OCTREOTIDE VERSUS OCTREOTIDE ALONE IN ACROMEGALY
PREVALENCE OF GROWTH HORMONE DEFICIENCY & RANGES OF IGF-1 IN NORMAL ELDERLY
PREVALENCE OF GROWTH HORMONE DEFICIENCY & RANGES OF IGF-1 IN NORMAL ELDERLY
Prevalence of Growth Hormone Deficiency & Ranges of IGF-1 in Normal Elderly
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