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(DCTD)癌症治疗评估计划(CTEP)管理。 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果，评估其他相关的生物效果，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。 具体目标： 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 目的是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、人数不足的种族和/或预期会出现差异的民族群体。

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: 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.