Early Therapeutics Development with Phase II Emphasis

该合同由国家癌症研究所 (NCI) 癌症治疗和诊断部门 (DCTD) 癌症治疗评估计划 (CTEP) 管理。 该合同的目的是对 NCI 资助的药物进行 2 期和早期临床试验，评估这些药物对其分子靶点的生物效应，评估其他相关的生物效应并确定临床相关结果/相关性。主要重点是 2 期研究、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 工作人员将确定的高优先级研究通知承包商。 NCI 还根据可用资源和优先事项考虑研究者发起的本合同项下的信贷试验。 具体目标是： o 快速开展必要的临床试验，以评估抗肿瘤活性，并实施 NCI 资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。虽然大多数试验将进行 II 期试验，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 获取并处理患者的血液、正常组织和肿瘤组织，并在方案要求时进行用于研究目的的成像评估。 o 研究新药的相关生物制剂效应。 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；并且， o 确定这些药物的安全性和有效性，并探索特殊患者群体中的药代动力学/药效学相关性，例如终末器官功能受损的患者、老年人群、预计存在差异的代表性不足的种族和/或族裔群体。

This contract is managed by the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI). The purpose of the 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. Specific Objectives are: 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.