CALGB 60301: SORAFENIB FOR SOLID TUMORS AND HEMATOLOGIC MALIGNANCIES

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。Sorafenib或BAY 43-9006是一种抑制RAF激酶的新型口服抗癌药物。该制剂对肾癌有抗肿瘤活性，对结直肠癌、黑色素瘤、甲状腺和胰腺癌也可能有抗肿瘤活性。这种新药的安全性及其在肝肾功能障碍患者中的清除率尚未得到评估。在这项I期临床试验中，肝肾功能不全的患者（也是一小部分肝肾功能正常的患者）将每天口服BAY 43-9006。如果一个队列中有3名患者没有毒性，则在接下来的3名患者中增加剂量，直到观察到毒性，然后总共有6名患者按该剂量进入。如果不止一名患者的剂量限制性毒性高于最大耐受剂量（MTD），而略低于该剂量的剂量将被视为该程度肝肾功能障碍的MTD。不同程度肝肾功能不全的患者，但不是两者都有，将在单独的队列中进行评估。

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.