Early Therapeutics Development with Phase II Emphasis

该合同由癌症治疗评估项目（CTEP）、癌症治疗和诊断部（DCTD）、国家癌症研究所（NCI）管理。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点的生物效应，评估其他相关生物效应，并确定临床相关结果/相关因素。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的高优先级研究，这些研究需要快速启动、完成和数据报告。NCI工作人员在确定高优先级研究后通知承包商。NCI还根据现有资源和优先级考虑研究人员发起的试验。

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.