Early Clinical Trials of New Anti-Cancer Agents

新型抗癌药物的早期临床试验

• 批准号: 7886178
• 负责人: PATRICIA M. LORUSSO
• 金额: $ 85.3万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-01 至 2013-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7886178
• 关键词: Address; Adult; Antineoplastic Agents; Arts; Biometry; Cancer Center; Cell Survival; Clinical; Clinical Pharmacology; Clinical Trials; Clinical Trials Design; Collaborations; Communities; Data; Decision Making; Development; Doctor of Medicine; Doctor of Philosophy; Dose; Dose-Limiting; Drug Delivery Systems; Drug Kinetics; Face; Functional disorder; Gefitinib; Goals; Growth; Hematologic Neoplasms; Image; Individual; Institutes; Institution; Ixabepilone; Laboratories; Location; Malignant Neoplasms; Maryland; Minority; NCI-Designated Cancer Center; Names; National Cancer Institute; New Agents; Organ; Patients; Pharmaceutical Preparations; Pharmacodynamics; Pharmacogenomics; Pharmacology; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Population; Population Study; Positioning Attribute; Positron-Emission Tomography; Principal Investigator; Process; Program Evaluation; Recommendation; Regulation; Research Personnel; Resources; Schedule; Services; Site; Solid Neoplasm; Surrogate Markers; Time; Toxic effect; Tracer; Translational Research; Underrepresented Minority; Universities; Woman; Work; Zoledronic Acid; angiogenesis; base; bench to bedside; cancer therapy; capecitabine; cytotoxic; design; drug candidate; drug development; experience; inner city; knowledge base; named group; novel; pre-clinical; programs; success; tool; tumor

Roughly 500 anti-cancer agents will be available for development within the next decade. The Phase I community will face significant challenges making swift and accurate go/no go drug developmentdecisions, due to limited resourcesfor continued clinical development as well as potentially unique profiles that the clinical drug candidates may unfold. It is important to be proactive, anticipating many of the challenges. Maximizing the knowledge base and combining resources to assist in overcoming many of these challenges will be a key component of continued success. Karmanos Cancer Institute (KCI) and University of Maryland Marlene & Stewart Greenebaum Cancer Center(UMGCC)jointly are submitting this proposal to maximize our strengths as a Phase I Consortium. The combined expertise of both institutions define us asthought eaders in pharmacokinetics (PK), pharmacodynamics (PD), imaging and biostatistics, all necessary components of an efficient and effective phase I program. Both institutions have recognized the greater need for understanding tumor-related targeted drug effects. Drs. LoRusso (KCI Principal Investigator) and Sausville (UMGCC Principal Investigator) have both involved exploration of PD effects of several different classes of agents. Dr. Sausville has developed a PD translational research laboratory at UMGCCto help further develop select PD endpoints for implementation in the clinical trials to be pursued by thisconsortium. The combined expertise of Drs. LoRusso and Sausville lend collectively at least 40 years experience in preclinical and clinical cancer drug development. Their efforts have led to the development of several commercially available or recently filed agents, including Velcade¿, Ontak¿, capecitabine, zoledronic acid, gefitinib, lapatanib, and ixabepilone, to name a few. Their programs have recognized that patient resources are valuable and limited, and have had significant success developing and evaluating novel trial designs to minimize patients treated at ineffective doses. The locations of both institutions lend themselves to service inner city populations with large women and minority bases, offering the potential for special population studies. Dr. Shields, our collaborator at KCI, has been a thought leader in PET imaging, with several tracers, including FDG and FLT, to his portfolio. This imaging oriented capacity is yet an additional unique feature available to his consortium. With the continued growth and expansion of both programs, we feel this collaboration will be well positioned for the continued development of novel agents offered through the Cancer Treatment Evaluation Program at the National Cancer Institute.

在未来十年内，将大约有500名抗癌代理人开发。第一阶段 社区将面临巨大的挑战，使得迅速而准确/没有毒品开发决策， 由于持续临床开发的资源有限，以及潜在的独特概况 临床候选药物可能会展开。重要的是要积极主动，可以预见许多挑战。 最大化知识库并结合资源以协助克服许多挑战 将是持续成功的关键组成部分。 Karmanos癌症研究所（KCI）和马里兰大学 Marlene＆Stewart Greenebaum癌症中心（UMGCC）共同提交此建议以最大化 我们作为I期财团的优势。这两个机构的综合专业知识都定义了我们的asthought 药代动力学（PK），药效学（PD），成像和生物统计学的ADER，所有这些都是必要的 有效有效的I期计划的组成部分。这两个机构都认识到更大 需要了解与肿瘤相关的靶向药物作用。博士。 Lorusso（KCI首席研究员）和 Sausville（UMGCC首席研究员）都涉及探索几种不同的PD效应 代理类。 Sausville博士已在UMGCCTO HILS开发了PD翻译的研究实验室 进一步开发精选的PD端点，以实施该临床试验。 博士的综合专业知识。 Lorusso和Sausville集体贷款至少40年的经验 临床前和临床癌症药物开发。他们的努力导致了几个 市售或最近提交的药物，包括Velcade¿，Ontak¿，Capecitabine，Zoledronic Acid， Gefitinib，Lapatanib和Ixabepilone仅举几例。他们的计划已经认识到患者资源 有价值和有限，并在开发和评估新颖的试验设计方面取得了重大成功 最小化以无效剂量治疗的患者。这两个机构的位置都借给自己服务 内城有大妇女和少数民族基地，为特殊人口提供了潜力 研究。我们在KCI的合作者Shields博士一直是宠物成像的思想领导者，有几个示踪剂， 包括FDG和FLT，包括他的投资组合。这种面向成像的容量仍然是一个附加的独特功能 可用于他的财团。随着两个计划的持续增长和扩展，我们感到 合作将是通过持续开发的新颖代理商的合作位置 国家癌症研究所的癌症治疗评估计划。