CLINICAL TRIALS CORE

临床试验核心的目标是提供专业知识和基础设施，以促进完成 本计划项目拨款中提出的所有以患者为基础的研究组成部分。核心目标将是 通过实现以下具体目标来实现。 1.使用HIF1-α抑制剂进行I期临床和药代动力学/药效学(PK/PD)试验， PX-478，结合放射治疗乳腺癌骨转移(项目1，PI- Garth Powis，D.Phil)。 2.对吉西他滨难治的患者进行新药物亚胺施密顿的II期临床试验 胰腺癌(项目2，PI-Robert Dorr，博士)。 3.帮助整合专注于测量应激反应和缺氧的新成像技术 进入临床试验的实体肿瘤(项目3，PI-罗伯特·吉利斯博士)。 4.设计和进行额外的I期和II期临床试验，与其他干扰 肿瘤对应激和缺氧的反应，如PS激酶抑制剂PX-886(项目1)，氰基吡啶类似物 (项目2)，以及可能单独或与辐射或联合使用的其他制剂(即mTOR抑制剂) 化疗药物。 核心C将通过组建一支临床研究团队并支持研究来实现这些目标 亚利桑那州癌症中心的工作人员将与项目和核心领导密切合作，翻译小说 从长椅到床边的治疗和诊断概念。

The goal of the Clinical Trials Core is to provide the expertise and infrastructure to facilitate the completion of all of the patient-based components of research proposed in this Program Project Grant. The core goals will be achieved through accomplishing the following specific aims. 1. Conduct a phase I clinical and pharmacokinetic/pharmacodynamic (PK/PD) trial with HIF1-alpha inhibitor, PX-478, given in combination with radiation therapy for bone metastasesfrom breast cancer ( Project 1, Pi- Garth Powis, D. Phil). 2. Conduct a phase II clinical trial with the new agent imexon for patients with gemcitabine-refractory pancreatic cancer (Project 2, Pi-Robert Dorr, Ph.D). 3. Help integrate new imaging technology that focuses on the measurement of stress response and hypoxia in solid tumors into clinical trials (Project 3, Pi-Robert Gillies, Ph.D.). 4. Design and conduct additional phase I and II clinical trials with other novel agents that interfere with tumor response to stress and hypoxia such as PIS kinase inhibitor PX-886 (Project 1), cyanaziridine analogs (Project 2), and possibly other agents (i.e. mTOR inhibitor) alone or in combination with radiation or chemotherapy drugs. The core C will accomplish these aims by assembling a team of clinical investigators and support research staff at the Arizona Cancer Center that will work closely with project and core leaders on translating novel therapeutic and diagnostic concepts from the bench to the bedside.