PHASE I CLINICAL TRIALS OF ANTICANCER AGENTS
抗癌药物的一期临床试验
基本信息
- 批准号:2113827
- 负责人:
- 金额:$ 34.52万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:1995
- 资助国家:美国
- 起止时间:1995-05-15 至 1998-02-28
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
The specific goals of the grant are:
a. To define the acute toxicities of new anticancer agents in patients
with advanced cancer.
b. To re-define the acute toxicities and pharmacokinetics of existing
anticancer agents administered in combination with colony stimulating
factors and other toxicity-ameliorating agents which may facilitate the
exploration of more effective doses and schedules.
c. To provide information on the pharmacologic characteristics
(absorption, distribution, metabolism, and elimination) of selected
antitumor agents.
d. To define treatment regimens for evaluation of antitumor activity in
Phase II trials.
e. Based on pharmacologic characteristics, to establish appropriate Phase
II doses in special patient populations, such as those with impaired end-
organ function or with heavy pretreatment, geriatric populations, and to
explore pharmacokinetic and pharmacodynamic differences based on gender,
race or ethnic group.
f. To obtain preliminary information on pharmacokinetic/pharmacodynamic
correlations with can then be extended in Phase II trials.
g. To incorporate ancillary basic laboratory studies, when possible and
appropriate, to enhance our understanding of the biochemical and/or
biological mechanisms of drug actions.
The agents to be studied will include the following:
a. Cytotoxic chemotherapeutic agents identified by the NCIs drug screening
program.
b. Cytotoxic agents with novel mechanisms, including antiangiogenesis
agents, differentiating agents, apoptosis-inducing agents, anti-sense
oligonucleotides and related gene-specific therapeutic agents, and targeted
cytoxic agents.
C. Existing chemotherapeutic agents which, when administered with colony
stimulating factors or other agents to ameliorate dose-limiting toxicities,
can be given in doses substantially higher than those previously tested.
d. Agents developed by the pharmaceutical industry and provided to the NCI
for collaborative development.
This grant shall accrue at least 25-50 patients per year to at least three
active phase I trials per year for five years. Pharmacokinetics and/or
correlative lab studies shall be a standard feature of these studies.
Pharmacokinetics will be assessed in an ongoing manner in proximity to
treatment rather than in a batched manner to facilitate incorporation of
pharmacokinetic data in dosing decision-making. Some phase I studies of
combination and/or modulation studies may not require intensive
pharmacokinetic data collection and this, as well as the credit to be
assigned, will be determined at the time of the Letter of intent (LOI)
review or protocol review by program staff.
赠款的具体目标是:
a.确定新型抗癌药物对患者的急性毒性
晚期癌症患者
B.重新定义现有药物的急性毒性和药代动力学
抗癌药与集落刺激联合给药
因子和其他毒性改善剂,这可能有助于
探索更有效的剂量和时间表。
C.提供药理学特征信息
(吸收、分布、代谢和消除)
抗肿瘤剂。
D.确定治疗方案,以评价在以下患者中的抗肿瘤活性:
II期临床试验。
e.根据药理学特征,确定适当的阶段
特殊患者人群中的II剂量,如终末-
器官功能或重度预处理,老年人群,以及
探索基于性别的药代动力学和药效学差异,
种族或民族。
F.获得药代动力学/药效学的初步信息
然后可以在II期试验中扩展相关性。
G.在可能的情况下,纳入辅助基础实验室研究,
适当的,以提高我们对生物化学和/或
药物作用的生物学机制。
待研究的药物包括:
a. NCIs药物筛选鉴定的细胞毒性化疗药物
程序.
B.具有新机制的细胞毒性药物,包括抗血管生成
试剂,分化剂,骨化诱导剂,反义
寡核苷酸和相关基因特异性治疗剂,以及靶向
细胞毒剂
C.现有的化疗剂,当与集落一起施用时,
刺激因子或其它试剂以改善剂量限制性毒性,
可以以比先前测试的剂量高得多的剂量给予。
D.由制药行业开发并提供给NCI的药剂
合作发展。
该补助金每年至少应增加25-50名患者,其中至少有3名患者
每年进行一期临床试验药代动力学和/或
相关实验室研究应是这些研究的标准特征。
药代动力学将在接近
处理,而不是以分批的方式,以促进掺入
给药决策中的药代动力学数据。一些I期研究
联合和/或调节研究可能不需要密集的
药代动力学数据收集和这一点,以及信贷
在签订意向书(LOI)时,
由项目工作人员进行审查或方案审查。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('DAVID A VAN ECHO', 18)}}的其他基金
PHASE I AND PHARMACOKINETIC STUDIES OF ANTICANCER AGENTS
抗癌药物的 I 期研究和药代动力学研究
- 批准号:
3607851 - 财政年份:1990
- 资助金额:
$ 34.52万 - 项目类别:
PHASE I AND PHARMACOKINETIC STUDIES OF ANTICANCER AGENTS
抗癌药物的 I 期研究和药代动力学研究
- 批准号:
3607853 - 财政年份:1990
- 资助金额:
$ 34.52万 - 项目类别:
PHASE I AND PHARMACOKINETIC STUDIES OF ANTICANCER AGENTS
抗癌药物的 I 期研究和药代动力学研究
- 批准号:
3607860 - 财政年份:1990
- 资助金额:
$ 34.52万 - 项目类别:
PHASE I AND PHARMACOKINETIC STUDIES OF ANTICANCER AGENTS
抗癌药物的 I 期研究和药代动力学研究
- 批准号:
3607849 - 财政年份:1990
- 资助金额:
$ 34.52万 - 项目类别:
PHASE I AND PHARMACOKINETIC STUDIES OF ANTICANCER AGENTS
抗癌药物的 I 期研究和药代动力学研究
- 批准号:
3607857 - 财政年份:1990
- 资助金额:
$ 34.52万 - 项目类别:
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