CALGB 60301: SORAFENIB FOR SOLID TUMORS AND HEMATOLOGIC MALIGNANCIES

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。索拉非尼或BAY 43-9006是一种新型口服抗癌药物，可抑制RAF激酶。该制剂具有抗肾癌活性，对结直肠癌、黑色素瘤、甲状腺癌和胰腺癌也有抗肿瘤活性。这种新药物的安全性和清除性尚未在肝或肾功能障碍患者中进行评估。在这项I期试验中，有肝或肾功能障碍的患者(也有一小部分肝肾功能正常的患者)将每天服用Bay 43-9006。如果三名患者没有毒性，接下来三名患者的剂量将逐步增加，直到观察到毒性，然后总共有六名患者进入该剂量。如果多个患者的剂量限制毒性将高于最大耐受量(MTD)，且略低于最大耐受量(MTD)的剂量将被视为该程度肝或肾功能障碍的MTD。有不同程度肝或肾功能障碍的患者，但不是两者都有，将在不同的队列中进行评估。

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. Sorafenib or BAY 43-9006 is a new oral anti cancer drug which inhibits the RAF kinase. This agent has activity against renal cancer and may also have anti tumor activity in colorectal cancer, melanoma, thyroid and pancreatic cancer. The safety of this new agent and its clearance has not been evaluated in patients with liver or renal dysfunction. In this phase I trial, patients with liver or kidney dysfunction (also a small cohort of patients with normal liver and renal function) will receive daily oral BAY 43-9006. If a cohort of three patients has no toxicity, the dose will be escalated in the next three patients until toxicity is observed and then a total of six patients would be entered at that dose. If more than one patient has a dose limiting toxicity that will be above the maximally tolerated dose (MTD) and the dose just below that will be considered the MTD for that degree of liver or renal dysfunction. Patients with varying degrees of liver or renal dysfunction, but not both, will be evaluated in separate cohorts.