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，大约有500种抗癌药物可供开发。第一阶段