AN OPEN-LABEL, MULTICENTER, PHASE II STUDY EVALUATING THE SAFETY AND EFFICACY O

一项开放标签、多中心、II 期研究，评估 O 的安全性和有效性

• 批准号: 8174488
• 负责人: CHRISTINA C. WANG
• 金额: $ 0.18万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8174488
• 关键词: Biochemical; Computer Retrieval of Information on Scientific Projects Database; Consent; Diabetes Mellitus; Endocrine; Evaluation; Funding; Grant; Hormones; Hydrocortisone; In complete remission; Institution; Magnetic Resonance Imaging; Measurement; Newly Diagnosed; Operative Surgical Procedures; Oral cavity; Patients; Phase; Phase II Clinical Trials; Physicians; Pituitary Gland; Pituitary Neoplasms; Pituitary-dependent Cushing' s disease; Research; Research Personnel; Residual Tumors; Resources; Role; Safety; Source; Therapeutic; United States Food and Drug Administration; United States National Institutes of Health; follow up assessment; open label; response; rosiglitazone; treatment duration; tumor; urinary

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. This Phase II clinical trial sponsored by the Food and Drug Administration will examine the potential therapeutic role for rosiglitazone in 15 patients with newly diagnosed Cushing's Disease, in 15 patients who still have active Cushing's disease despite pituitary surgery, and in 15 patients with non-secreting pituitary tumors either newly diagnosed or who has residual tumor at least 3 months after pituitary surgery. Consenting patients will undergo a detailed baseline historical, physician and biochemical evaluation, including measurement of the specific hormone(s), their pituitary tumor produces, and an MRI assessment of the pituitary tumor size. Patients will commence treatment with Rosiglitazone, (4 mg for i week and then 8 mg by mouth daily for the duration of the study treatment period) approved for use in diabetes mellitus. Biochemical and endocrine examination will be re-evaluated monthly, radiological examination at 6 months, and rosiglitazone therapy will continue for a total treatment period of 6 weeks in the newly diagnosed Cushing's patients (Aim 1), 6 months in Cushing's patients who had elevated cortisol levels after pituitary surgery and 12 months in patients with non-secreting tumors. Patient response will be determined by a statistical comparison of the follow-up assessments with baseline result. A complete response will be defined as normalization of urinary cortisol levels in the Cushing's patients and disappearance of pituitary tumors in the non-secreting tumors from baseline.

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。 这项由美国食品药品监督管理局赞助的II期临床试验将在15名新诊断的库欣病患者、15名垂体手术后仍有活动性库欣病的患者和15名新诊断的或垂体手术后至少3个月有肿瘤残留的非分泌性垂体瘤患者中检查罗格列酮的潜在治疗作用。 患者将接受详细的基线历史，医生和生化评估，包括特定激素的测量，他们的垂体肿瘤产生，以及垂体肿瘤大小的MRI评估。 患者将开始用批准用于糖尿病的罗格列酮治疗（4 mg持续1周，然后在研究治疗期期间每天口服8 mg）。 每月重新评估一次生化和内分泌检查，6个月时进行放射学检查，罗格列酮治疗将在新诊断的库欣患者（目的1）中持续6周的总治疗期，在垂体手术后皮质醇水平升高的库欣患者中持续6个月，在非分泌性肿瘤患者中持续12个月。 将通过随访评估与基线结果的统计学比较确定患者应答。 完全缓解将定义为库欣患者的尿皮质醇水平正常化，非分泌性肿瘤中的垂体瘤从基线消失。