IMATINIB MESYLATE-RESISTANT OR INTOLERANT MALIGNANT GASTROINTESTINAL TUMOR

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。这是一项双臂、双盲、安慰剂对照、多中心、3期临床试验，采用2：1随机试验，与安慰剂相比，评估单药SU011248对甲磺酸伊马替尼耐药或不耐受的恶性胃肠道间质瘤(GIST)的疗效和安全性。被随机分配到安慰剂组(B组)的患者将有机会在出现RECIST定义的疾病进展时接受开放标签SU011248治疗，前提是患者符合交叉资格标准。安全实验室、药代动力学(PK)低谷水平和可溶性蛋白评估将作为研究的一部分。

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 is a dual-arm, double-blind, placebo-controlled, multicenter, Phase III clinical trial with 2:1 randomization evaluating the efficacy and safety of single-agent SU011248, as compared to placebo, in patients with Imatinib Mesylate-resistant or intolerant malignant gastrointestinal stromal tumor (GIST). Patients randomized to the placebo arm (Arm B) will be offered the opportunity to receive open-label SU011248 treatment upon development of RECIST-defined disease progression, provided that patient crossover eligibility criteria are met. Safety labs, pharmacokinetic (PK) trough levels and soluble protein assessment will be drawn as part of the study.