Early Clinical Trials of New Anti-Cancer Agents with Phase 1 Emphasis (U01)

以 1 期为重点的新型抗癌药物的早期临床试验 (U01)

• 批准号: 8228078
• 负责人: GLENN LIU
• 金额: $ 59.57万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-02-27 至 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8228078
• 关键词: Address; Antineoplastic Agents; Basic Science; Cancer Therapy Evaluation Program; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Comprehensive Cancer Center; Correlative Study; Data; Development; Discipline; Dose; Drug Interactions; Drug Kinetics; Evaluation; Evolution; Foundations; Funding; Future; Goals; Grant; Investigation; Malignant Neoplasms; Methods; Nature; New Agents; Patients; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Phase I/II Trial; Play; Research Infrastructure; Role; Schedule; Testing; Therapeutic; Treatment Protocols; United States National Institutes of Health; Universities; Wisconsin; active method; cancer care; cytotoxic; design; drug development; expectation; experience; innovation; meetings; named group; novel; oncology; pre-clinical research; programs; trend

DESCRIPTION (provided by applicant): The Phase I Program of the University of Wisconsin Paul P. Carbone Comprehensive Cancer Center (UWCCC) has been consistently performing high quality phase I drug development studies sponsored by the NCI since 1979. As a result, we have played an active role in the evolution of early drug development and built the foundation to help set the standard for the delivery of individualized cancer care in the future. This application represents the renewal of U01 CA062491. Our Phase I Program continues to emphasize the tradition of excellence in clinical trials established in 1979 with a commitment to: 1) support the diverse array of preclinical research being performed at the UWCCC; 2) provide a stable infrastructure devoted to clinical research; 3) maintain an outstanding group of clinical investigators who perform high quality trials; and 4) promote the interactions between experts throughout the UWCCC and campus. This application details our experience in NCI-sponsored drug development studies over the last grant period and also describes the methods by which we performed these studies. Our current and future objectives are: Objective 1: Conduct of targeted early phase clinical trials Objective 2: Assessment of pharmacokinetics to establish dose, schedule, exposure and effect relationships Objective 3: Explore novel paradigms and designs for the evaluation of new agents Objective 4: Study special populations in early phase clinical trial Objective 5: Establish safe and biologically active treatment schedules for novel agents Objective 6: Determine mechanistic proof of principle data for new molecularly targeted agents Objective 7: Evaluate combinations of CTEP IND agents to assess the nature of drug-drug interactions Objective 8: Evaluation of translational endpoints in clinical trials of investigational agents The UWCCC accrues an average of 535 patients per year to early-phase clinical trials (phase I and II), of which 225 are on phase I trials. This strong track record for early-phase clinical trials accrual assures that the Phase I Program has the capability to meet CTEP U01 accrual expectations of 50 patients per year. During the current grant period, the Phase I Program addressed all of the objectives noted above and accrued an average of 54 patients to approved U01 early phase clinical trials annually. While all Phase I Program UO1 trials had translational endpoints, correlative studies of seven of these trials received CTEP-TRI funding.

描述(由申请人提供)：威斯康星大学保罗·P·卡伯恩综合癌症中心(UWCCC)的第一阶段计划自1979年以来一直在进行由NCI赞助的高质量第一阶段药物开发研究。因此，我们在早期药物开发的演变中发挥了积极作用，并为帮助制定未来个性化癌症护理的标准奠定了基础。本申请代表U01 CA062491的续订。我们的第一阶段计划继续强调在1979年建立的临床试验中卓越的传统，承诺：1)支持UWCCC正在进行的多样化的临床前研究；2)提供致力于临床研究的稳定基础设施；3)保持一支出色的临床研究团队，进行高质量的试验；以及4)促进UWCCC和校园内专家之间的互动。这份申请书详细介绍了我们在上一次资助期间由NCI赞助的药物开发研究的经验，并描述了我们进行这些研究的方法。我们当前和未来的目标是：目标1：进行有针对性的早期临床试验目标2：评估药代动力学以确定剂量、时间表、暴露和效果关系目标3：探索新药物评估的新范例和设计目标4：在早期临床试验中研究特殊人群目标5：为新药物建立安全和生物活性的治疗方案目标6：为新的分子靶向药物确定原理数据的机械证据目标7：评估CTEP IND药物的组合以评估药物-药物相互作用的性质目标8：在研究药物的临床试验中对翻译终点的评估UWCCC平均每年为早期临床试验(I期和II期)积累患者，其中225人处于I期试验。这一良好的早期临床试验应计记录确保了第一阶段计划有能力满足CTEP U01每年50名患者的应计期望。在当前的赠款期间，第一阶段计划实现了上述所有目标，每年平均有54名患者参加批准的U01早期临床试验。虽然所有I期计划UO1试验都有翻译终点，但其中7项试验的相关研究得到了CTEP-TRI资助。