TAS:: 75 0850 ::TAS RECOVERY ACT - ACTNOW CLINICAL TRIAL 8472

塔斯马尼亚州:: 75 0850 ::塔斯马尼亚州恢复法案 - ACTNOW 临床试验 8472

• 批准号: 7933252
• 负责人: MIGUEL A VILLALONA-CALERO
• 金额: $ 75.47万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-01-01 至 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7933252
• 关键词: TAS; 75; 0850; RECOVERY; ACT

This project, managed the Cancer Therapeutics Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis, (DCTD), National Cancer Institute (NCI), was funded with ARRA stimulus funding under the Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) program. The research study supported by this funding is: "ABT-888 as Monotherapy and in Combination with Mitomycin C in Patients with Solid Tumors with Deficiency in Homologous Recombination Repair" Trials funded under this ACTNOW will test novel agents (alone, in combination, and with other standard therapies) that target new pathways by which cancer cells grow, metastasize and develop resistance to current treatments. The trials will receive enhanced resources to enable rapid development and approval of the treatment protocol such that 90 days from notification of the award, the trial will either be open to enrollment or in review at the local institutional review board. This timeline is significantly faster than is typically attained by industry-sponsored early clinical trials, and is about 9 months faster than NCI¿s standard approach to trial development. This accelerated timeline is possible due to the resources provided by ARRA. These resources will allow more staff to be hired and devoted to protocol writing and statistical plans, and will increase personnel available for database and case report form development. This set of trials will also be greatly enhanced by the ARRA funding which will permit the use of innovative diagnostic scans, specimen sample collection and assay development and adequate reimbursement for the research costs associated with data management at local sites. Lack of funds for these research costs has traditionally resulted in significant delays in time to study initiation. Avoidance of protracted negotiations with pharmaceutical partners, diagnostic companies, and philanthropic organizations, that have usually been needed to bridge the funding gap unmet by NCI, will permit the trials to be activated more quickly. The purpose of this contract is to conduct Phase 2 and early clinical trials of NCI-sponsored agents, evaluate biologic effects of these agents on their molecular targets, evaluate other relevant biologic effects and determine clinically relevant outcomes/correlates. Major emphasis is on Phase 2 studies, pilot protocols that explore promising combination therapies, and high priority studies that are pivotal for drug development and require rapid initiation, completion, and data reporting. NCI staff notify the Contractor of high priority studies as they are identified. NCI also considers investigator-initiated trials for credit under this contract based on available resources and priorities. The contractor will: o Rapidly conduct clinical trials necessary to assess the anti-tumor activity and carry out the development plans for NCI-sponsored agents of varying classes, many of which are directed at new cancer targets. While the majority of trials will be Phase II, some studies designed to develop or assess dose, schedule and pharmacodynamic questions shall be conducted under this contract. o Obtain and process blood, normal and tumor tissue from patients and carry out imaging evaluations for research purposes when required by the protocols. o Study relevant biologics effects of new agents. o Study relevant pharmacology. o Determine the antitumor activity of selected combinations of antitumor agents or combinations involving radiotherapy; and, o Determine the safety and efficacy of these agents and explore pharmacokinetic/pharmacodynamic correlations in special patient populations, such as those with impaired end-organ function, geriatric populations, under-represented racial and/or ethnic groups in whom differences would be anticipated.

该项目由美国国家癌症研究所 (NCI) 癌症治疗和诊断部 (DCTD) 癌症治疗评估计划 (CTEP) 管理，并由 ARRA 加速新型肿瘤途径临床试验 (ACTNOW) 计划下的刺激资金资助。 该资金支持的研究是：“ABT-888 作为单一疗法并与丝裂霉素 C 联合治疗同源重组修复缺陷的实体瘤患者” ACTNOW 资助的试验将测试针对癌细胞生长、转移和对当前治疗产生耐药性的新途径的新型药物（单独、联合或与其他标准疗法）。这些试验将获得更多资源，以实现快速开发和治疗。批准治疗方案，以便在收到奖励通知后 90 天，试验将开放注册或在当地机构审查委员会进行审查，这一时间表比行业资助的早期临床试验通常要快得多，比 快约 9 个月国家癌症研究所由于 ARRA 提供的资源，这种加速时间表是可能的，这些资源将允许雇用更多的工作人员并致力于方案编写和统计计划，并将增加可用于数据库和病例报告表开发的人员。 ARRA 的资助也将大大加强这组试验，这将允许使用创新的诊断扫描、标本采集和分析开发，并充分补偿与当地缺乏资金的数据管理相关的研究费用。传统上，研究成本会导致时间上的严重延误研究启动。避免与制药合作伙伴、诊断公司和慈善组织进行旷日持久的谈判（通常需要这些谈判来弥补 NCI 未满足的资金缺口），这将使试验能够更快地启动。 该合同的目的是对 NCI 赞助的药物进行 2 期和早期临床试验，评估这些药物对其分子靶标的生物效应，评估其他相关生物效应并确定临床相关结果/相关性。主要重点是 2 期。探索有前途的联合疗法的试点方案，以及对药物开发至关重要并需要快速启动、完成和数据报告的高优先级研究，NCI 工作人员也会在确定高优先级研究时通知承包商。已启动试验根据本合同，承包商将根据可用资源和优先事项获得信用： o 快速开展必要的临床试验，以评估抗肿瘤活性，并实施 NCI 赞助的不同类别药物的开发计划，其中许多针对新药物。虽然大多数试验将进行 II 期试验，但应根据本合同进行一些旨在开发或评估剂量、时间表和药效学问题的研究 o 获取并处理患者的血液、正常组织和肿瘤组织并进行影像学评估。当协议要求时用于研究目的 o 相关研究。 o 研究相关药理学 o 确定选定的抗肿瘤药物组合或涉及放射治疗的组合的抗肿瘤活性；以及， o 确定这些药物的安全性和有效性，并探索特殊患者群体的药代动力学/药效学相关性。例如那些终末器官功能受损的人、老年人群、代表性不足的种族和/或族裔群体，这些群体中预计会存在差异。