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.

该项目管理的癌症治疗学评估计划（CTEP），癌症治疗和诊断部（DCTD），国家癌症研究所（NCI），在新型肿瘤途径（ACTNOW）计划的加速临床试验下，资助了ARRA刺激资金。 这项资金支持的研究研究是：“ ABT-888作为单一疗法，并与丝裂霉素C结合在同源重组修复方面缺乏的实体瘤患者中”。 根据此ACTNOW资助的试验将测试新型药物（单独，结合使用和其他标准疗法），该试验针对癌细胞生长，转移和发育耐药性的新途径。这些试验将获得增强的资源，以实现快速开发和批准治疗方案，以便从奖励通知后的90天，该试验将在当地机构审查委员会开放或进行审查。该时间表的速度要比行业赞助的早期临床试验所附带的速度要快得多，并且比NCI的标准试验开发方法快9个月。由于ARRA提供的资源，因此可以加速的时间表。这些资源将使更多的员工被携带和部署到协议写作和统计计划，并将增加可用于数据库和案例报告表格开发的人员。 ARRA资金还将大大提高这组试验，这将允许使用创新的诊断扫描，标本样本收集和分析开发以及与本地网站数据管理相关的研究成本的充分报销。传统上，缺乏这些研究成本的资金导致及时延迟研究计划。避免与药物合作伙伴，诊断公司和慈善组织进行旷日持久的谈判，这些组织通常需要弥合NCI的资金差距，这将使试验能够更快地激活试验。 该合同的目的是进行NCI赞助的药物的第2阶段和早期临床试验，评估这些药物对其分子靶标的生物学效应，评估其他相关的生物学效应并确定临床相关的结果/相关性。主要重点是第二阶段研究，探索有希望的组合疗法的试点方案以及对药物开发至关重要的高优先级研究，需要快速启动，完成和数据报告。 NCI工作人员将其确定为高优先研究。 NCI还根据可用的资源和优先级考虑了根据本合同的信用审查的研究者提出的试验。承包商将：o迅速进行临床试验，以评估抗肿瘤活性并执行不同类别的NCI赞助的代理的开发计划，其中许多针对新的癌症靶标。虽然大多数试验将是第二阶段，但一些旨在开发或评估剂量，时间表和药效学问题的研究应根据本合同进行。 o从患者那里获取并处理血液，正常组织和肿瘤组织，并在协议需要时进行研究目的进行成像评估。 o研究新药物的相关生物制剂。 o研究相关药理学。 o确定抗肿瘤剂或涉及放射疗法的组合的选定组合的抗肿瘤活性； o o确定这些药物的安全性和效率，并探索特殊患者人群中的药代动力学/药效学相关性，例如最终器官功能受损的人群，老年人群，代表性不足的种族和/或种族群体的差异。