VORICONAZOLE IN PATIENTS WITH HEMATOLOGIC MALIGNANCIES

伏立康唑治疗血液系统恶性肿瘤患者

• 批准号: 6246459
• 负责人: JEFFREY L. BLUMER
• 金额: $ 1.98万
• 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: 1997-01-06 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6246459
• 关键词: antineoplastics; blood /lymphatic neoplasm; bone marrow transplantation; clinical research; drug adverse effect; fluconazole; human subject; human therapy evaluation; neoplasm /cancer chemotherapy

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.

这项研究的目的是评估安全性，容忍度和 三种剂量的药代动力学（200 mg竞标，300 mg竞标和400 mg竞标） 与（主动）对照相比，口服伏立康唑（氟康唑在400 mg/day），在血液学恶性肿瘤/疾病的患者中，固体 肿瘤，或具有自体骨髓移植的患者 曲霉病的发展。 将进行这项随机，双盲，主动控制的研究 最多三个顺序的相位，在三个或更多位置。 在每个阶段 在这项研究中，将按顺序招募足够数量的患者 产生12个可评估的案例。 这项研究刚刚开始患者 应计。 出于该协议的目的，可评估的情况将是 定义如下：1）已完成整个14天的患者 治疗期；或2）由于一个因 与治疗相关的不良事件。