TAS:: 75 0850 ::TAS RECOVERY ACT - ACTNOW CLINICAL TRIAL 8155

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，由ARRA刺激资金根据新肿瘤路径加速临床试验(ActNow)计划提供资金。 这项支持的研究是：“抗IGF-1R单抗IMCA12和标准剂量索拉非尼治疗晚期肝细胞癌的I期试验。” ActNow资助的试验将测试新的药物(单独、联合和其他标准疗法)，这些药物针对癌细胞生长、转移和对当前治疗产生抗药性的新途径。试验将获得更多的资源，以便能够迅速制定和批准治疗方案，以便在获奖通知后90天内，试验将开放供登记，或在当地机构审查委员会进行审查。这一时间线明显快于行业赞助的早期临床试验通常所达到的速度，并且比美国国立卫生研究院S试验开发的标准方法快约9个月。由于ARRA提供的资源，这一加速的时间表是可能的。这些资源将使雇用更多的工作人员并专门用于编写礼宾和统计计划，并将增加可用于开发数据库和案件报告表的人员。ARRA的资金也将大大加强这套试验，这将允许使用创新的诊断扫描、样本采集和化验开发，并充分报销与当地站点数据管理相关的研究费用。缺乏用于这些研究费用的资金，传统上会导致研究启动时间的重大延误。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，这将使试验能够更快地启动，而NCI通常需要这些谈判来弥补资金缺口。 该合同的目的是进行NCI赞助的药物的第二阶段和早期临床试验，评估这些药物对其分子靶标的生物效应，评估其他相关的生物效应，并确定临床相关的结果/相关性。主要重点是第二阶段研究，探索有前景的联合疗法的试点方案，以及对药物开发至关重要、需要快速启动、完成和数据报告的高优先级研究。NCI工作人员在确定高优先级研究后通知承包商。NCI还根据可用的资源和优先顺序考虑调查人员发起的本合同下的信用试验。承包商将：o快速进行必要的临床试验，以评估抗肿瘤活性，并执行NCI赞助的不同类别药物的开发计划，其中许多药物针对新的癌症靶点。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将根据本合同进行。O获取和处理患者的血液、正常组织和肿瘤组织，并在协议要求时进行成像评估以用于研究目的。O研究新制剂的相关生物效应。O学习相关药理学。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，确定这些药物的安全性和有效性，并在特殊患者群体中探索药代动力学/药效学相关性，例如终末器官功能受损的人群、老年人群、人数不足的种族和/或预期会出现差异的民族群体。

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 study supported is: "A Phase I Trial of Escalating Doses of the Anti-IGF-1R Monoclonal Antibody IMCA12 and Standard Dose Sorafenib for Treatment of Advanced Hepatocellular Carcinoma." 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.