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临床试验/NCT02749227
NCT02749227终止2 期

Pilot Study of Pasireotide LAR Treatment of Silent Corticotrophin Pituitary Tumors and Effects on Plasma Levels of POMC

Columbia University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年7月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
4
试验地点
1
主要终点
Change in Plasma Proopiomelanocortin (POMC) Levels

研究概览

简要总结

This is a phase II, open-label, 12-month pilot study in 10 patients with silent corticotroph pituitary tumors testing the hypotheses that Pasireotide long-acting release (LAR) treatment of patients with silent corticotroph pituitary tumors and elevated plasma Proopiomelanocortin (POMC) levels will reduce plasma POMC levels and this will be associated with a reduction in pituitary tumor size. Pasireotide LAR 40 mg will be administered monthly. Baseline and monthly visits on therapy will monitor plasma levels of POMC, other pituitary function, safety labs, glucose tolerance, physical examination, and visual fields. Pituitary magnetic resonance imaging (MRI) will be done at baseline, 6 months and 12 months of therapy. The eligible patient population will consist of adult patients with known silent corticotroph pituitary tumors and elevated plasma levels of POMC.

详细描述

Clinically non-functioning pituitary adenomas (CNFAs), the subtype of pituitary adenomas that does not appear to secrete biologically active hormone nor to have a characteristic clinical phenotype, are the most common type of pituitary macroadenoma at diagnosis. There is currently no option for medical therapy of CNFA, in general, or specifically of silent corticotroph tumors. Silent corticotroph tumors can range from being completely asymptomatic to becoming large and causing significant hypothalamic/pituitary dysfunction and visual symptoms, and most data support that this type of tumor has a more aggressive phenotype. Current therapy consists primarily of surgical removal of the tumor and for recurrent or residual tumors, repeated surgery and/or radiotherapy. In very aggressive tumors, chemotherapy has been tried with some success. Therefore, a need exists for a medical therapeutic option for the treatment of this tumor type. This project assesses this clinical need.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Pasireotide LAR Therapy

Experimental

Subjects will receive Pasireotide LAR monthly. Safety labs and Pituitary MRI will be performed.

干预措施: Pasireotide LAR (Drug)

结局指标

主要结局

Change in Plasma Proopiomelanocortin (POMC) Levels

时间窗: Baseline, 12 months

This is to measure the effect of Pasireotide LAR (long-acting release) treatment.

次要结局

  • Change in Pituitary Tumor Volume(Baseline, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pamela U. Freda

Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Endocrinology

Columbia University

研究点 (1)

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