CLINICAL TRIAL: SOM230 IM LAR INJECTION IN PATIENTS WITH ACROMEGALY AND CARCIN

临床试验：SOM230 IM LAR 注射液治疗肢端肥大症和癌患者

• 批准号: 7717909
• 负责人: LAURENCE KATZNELSON
• 金额: $ 0.36万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717909
• 关键词: Acromegaly; Affinity; Binding; Carcinoid Tumor; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Drug Formulations; Exhibits; Funding; Grant; Human; Injection of therapeutic agent; Institution; Neuroendocrine Tumors; Patients; Pharmaceutical Preparations; Pharmacodynamics; Pituitary Gland Adenoma; Purpose; Research; Research Personnel; Resources; SOM-230; Safety; Somatostatin Receptor; Source; Syndrome; Time; United States National Institutes of Health; concept; day; disorder control; novel; programs; receptor; somatostatin analog

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. GH-secreting pituitary adenomas (causing the syndrome of Acromegaly) and Neuroendocrine tumors(causing carcinoid disease), express somatostatin receptors. Currently available somatostatin analogs bind to only some of these receptors, and are therefore effective at controlling these diseases a fraction of the time. SOM230 is a novel somatostatin analogue that binds with higher affinity to four of the five known human somatostatin receptors, and therefore may be more effective. Critical to the SOM230 program is a viable monthly long-acting release (LAR) formulation which provides sufficient pharmacological activity with minimal safety/tolerability concerns in both patients with acromegaly and patients with carcinoid disease. The ideal SOM230 LAR formulation should provide sustained drug levels for approximately 28 days and exhibit acceptable safety and tolerability. The primary purpose of this study is to show sustained drug levels, safety, and tolerability of SOM230 LAR in patients with Acromegaly and Carcinoid disease. A secondary purpose of this study is to assess the pharmacodynamics of SOM 230 LAR for Acromegaly/Carcinoid (i.e. to obtain proof of concept evidence for its efficacy).

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 生长激素分泌型垂体腺瘤（引起肢端肥大症综合征）和神经内分泌肿瘤（引起类癌病）表达生长抑素受体。目前可用的生长抑素类似物仅与这些受体中的一些结合，因此在控制这些疾病的一小部分时间内有效。SOM 230是一种新型的生长抑素类似物，其与五种已知的人类生长抑素受体中的四种具有更高的亲和力，因此可能更有效。SOM 230项目的关键是一种可行的每月长效释放（LAR）制剂，该制剂在肢端肥大症患者和类癌患者中提供了足够的药理活性，且安全性/耐受性问题最小。理想的SOM 230 LAR制剂应提供持续约28天的药物水平，并表现出可接受的安全性和耐受性。 本研究的主要目的是显示SOM 230 LAR在肢端肥大症和类癌病患者中的持续药物水平、安全性和耐受性。本研究的次要目的是评估SOM 230 LAR治疗肢端肥大症/类癌的药效学（即获得其疗效的概念证据）。