Early Therapuetics with Phase II Emphasis

以 II 期为重点的早期治疗

• 批准号: 8014375
• 负责人: DANIEL M SULLIVAN
• 金额: $ 124.79万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 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/8014375
• 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; 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。