New trial designs to assess antitumor and antiproliferative agents in prostate cancer.

Abstract:

:The discovery of multiple putative therapeutic targets and multiple putative agents for these targets in prostate cancer in the coming years poses significant challenges for clinical trial design. This is especially true for cytostatic agents that are not expected to lead to frank tumor shrinkage or declines in the PSA. The most promising agents will need to be identified early in their development. Since surrogate biologic markers are likely to play a critical role, the identification and validation of these markers is discussed. A number of non-traditional phase I and phase II clinical trial designs, including pre-operative dosing for assessing drug effect on a marker and the randomized discontinuation phase II design, are also discussed in detail. Use of such designs as well as surrogate marker validation will likely be required to efficiently choose appropriate agents for definitive study in the phase III setting.

journal_name

Invest New Drugs

authors

Stadler W

doi

10.1023/a:1015618108456

subject

Has Abstract

pub_date

2002-05-01 00:00:00

pages

201-8

issue

2

eissn

0167-6997

issn

1573-0646

journal_volume

20

pub_type

杂志文章,评审
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    authors: Sharma S,Freeman B,Turner J,Symanowski J,Manno P,Berg W,Vogelzang N

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    journal_title:Investigational new drugs

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    doi:10.1007/BF00203541

    authors: van Lambalgen R,Lelieveld P

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    doi:10.1007/s10637-014-0116-3

    authors: Vlahovic G,Karantza V,Wang D,Cosgrove D,Rudersdorf N,Yang J,Xiong H,Busman T,Mabry M

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    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究

    doi:10.1007/s10637-016-0416-x

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    doi:10.1007/s10637-012-9888-5

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    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究,随机对照试验

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    pub_type: 杂志文章,评审

    doi:10.1023/a:1005722729132

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    pub_type: 杂志文章

    doi:10.1007/BF00216925

    authors: Fabian CJ,Molina R,Slavik M,Dahlberg S,Giri S,Stephens R

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    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1007/s10637-012-9842-6

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    更新日期:2013-02-01 00:00:00

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    journal_title:Investigational new drugs

    pub_type: 杂志文章

    doi:10.1007/s10637-014-0092-7

    authors: Izzedine H,Gueutin V,Gharbi C,Mateus C,Robert C,Routier E,Thomas M,Baumelou A,Rouvier P

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    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究

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    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章

    doi:10.1007/BF00177255

    authors: Ettinger DS,Finkelstein DM,Abeloff MD,Chang YC,Smith TJ,Oken MM,Ruckdeschel JC

    更新日期:1990-05-01 00:00:00

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    更新日期:1997-01-01 00:00:00

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    pub_type: 杂志文章,多中心研究

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    doi:10.1023/b:drug.0000006170.38419.c9

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    authors: Michels J,Lassau N,Gross-Goupil M,Massard C,Mejean A,Escudier B

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    pub_type: 杂志文章

    doi:10.1007/s10637-012-9848-0

    authors: Trarbach T,Przyborek M,Schleucher N,Heeger S,Lüpfert C,Vanhoefer U

    更新日期:2013-06-01 00:00:00

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    doi:10.1023/a:1006128024879

    authors: Meyers FJ,Lew D,Lara PN Jr,Williamson S,Marshall E,Balcerzak SP,Rivkin SE,Samlowski W,Crawford ED

    更新日期:1998-01-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1007/BF00173645

    authors: Mormont MC,von Roemeling R,Sothern RB,Berestka JS,Langevin TR,Wick M,Hrushesky WJ

    更新日期:1988-12-01 00:00:00