ORAL DOSES OF VORICONAZOLE IN PATIENTS WITH HEMATOLOGIC MALIGNANCIES

血液系统恶性肿瘤患者口服伏立康唑

• 批准号: 6276521
• 负责人: JEFFREY L. BLUMER
• 金额: $ 1.83万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6276521
• 关键词: antineoplastics; blood /lymphatic neoplasm; bone marrow transplantation; clinical research; clinical trial phase I; dosage; drug adverse effect; drug screening /evaluation; fluconazole; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; oral administration; pharmacokinetics

The objective of this study is to evaluate the safety, tolerance and pharmacokinetics of three doses (200 mg BID, 300 mg BID, and 400 mg BID) of oral voriconazole, compared to an (active) control (fluconazole at 400 mg/day), in patients with hematologic malignancies/conditions, solid tumors, or patients with autologous bone marrow transplants at risk for development of aspergillosis. This randomized, double-blind, active-controlled study will be conducted in up to three sequential phases, at three or more sites. In each phase of the study, a sufficient number of patients will be recruited in order to produce 12 evaluable cases. This study has just initiated patient accrual. For the purpose of this protocol, an evaluable case will be defined as follows: 1) a patient that has completed the full 14-day treatment period; or 2) a patient that has been discontinued because of a treatment-related adverse event.

本研究的目的是评价安全性、耐受性和 三种剂量（200 mg BID、300 mg BID和400 mg BID）的药代动力学 口服伏立康唑，与（活性）对照（氟康唑， 400 mg/天），在血液恶性肿瘤/疾病患者中，固体 肿瘤，或有自体骨髓移植风险的患者， 曲菌病的发展。 将进行这项随机、双盲、活性对照研究 在三个或三个以上的地点分三个连续的阶段进行。 每一相中 在本研究中，将招募足够数量的患者， 产生12个可评估病例。 这项研究刚刚开始， 权责发生制。 出于本方案的目的，可评价病例将 定义如下：1）已完成完整14天治疗的患者 治疗期;或2）因以下原因而停药的患者 与治疗相关的不良事件。