Early Therapeutics Development with Phase II Emphasis

以 II 期为重点的早期治疗开发

• 批准号: 8014377
• 负责人: MIGUEL A VILLALONA-CALERO
• 金额: $ 10.69万
• 依托单位: OHIO STATE UNIVERSITY RESEARCH FDN
• 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 2010-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8014377
• 关键词: Blood; Cancer Therapy Evaluation Program; Clinical Trials; Combined Modality Therapy; Conduct Clinical Trials; Contractor; Contracts; Data Reporting; Development Plans; Division of Cancer Treatment and Diagnosis; Dose; Drug Kinetics; Elderly; Ethnic group; Evaluation Research; Image Analysis; Malignant Neoplasms; Molecular Target; National Cancer Institute; New Agents; Organ; Outcome; Patients; Pharmacodynamics; Pharmacology; Phase; Population; Process; Protocols documentation; Radiation therapy; Research Design; Research Personnel; Resources; Safety; Schedule; Tumor Tissue; antitumor agent; base; clinically relevant; drug development; patient population; phase 2 study; therapeutic development; tumor

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.

该合同由国家癌症研究所（NCI）的癌症治疗评估计划（CTEP）（CTEP）（CTEP）管理。 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上相关的结果/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。 特定目标： 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赞助的药物的开发计划，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疗的组合的选定组合的抗肿瘤活性；和， o确定这些药物的安全性和功效，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/或种族群体的人群差异。