Literature DB >> 21283090

An accelerated pathway for targeted cancer therapies.

Mark McClellan1, Joshua Benner, Richard Schilsky, David Epstein, Ray Woosley, Stephen Friend, David Sidransky, Cindy Geoghegan, David Kessler.   

Abstract

A well-defined pathway for the accelerated development and approval of targeted cancer therapies and companion diagnostics would reduce uncertainty, improve efficiency in development and provide an effective incentive for developers.

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Year:  2011        PMID： 21283090     DOI： 10.1038/nrd3360

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


  6 in total

1.  Evaluating the efficiency of targeted designs for randomized clinical trials.

Authors:  Richard Simon; Aboubakar Maitournam
Journal:  Clin Cancer Res       Date:  2004-10-15       Impact factor: 12.531

2.  Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect.

Authors:  Wenyu Jiang; Boris Freidlin; Richard Simon
Journal:  J Natl Cancer Inst       Date:  2007-06-27       Impact factor: 13.506

Review 3.  Strategic paths for biomarker qualification.

Authors:  Federico M Goodsaid; Felix W Frueh; William Mattes
Journal:  Toxicology       Date:  2008-01-06       Impact factor: 4.221

4.  I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy.

Authors:  A D Barker; C C Sigman; G J Kelloff; N M Hylton; D A Berry; L J Esserman
Journal:  Clin Pharmacol Ther       Date:  2009-05-13       Impact factor: 6.875

5.  Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges.

Authors:  Sumithra J Mandrekar; Daniel J Sargent
Journal:  J Clin Oncol       Date:  2009-07-13       Impact factor: 44.544

6.  Randomized phase III clinical trial designs for targeted agents.

Authors:  Antje Hoering; Mike Leblanc; John J Crowley
Journal:  Clin Cancer Res       Date:  2008-07-15       Impact factor: 12.531
  6 in total
  12 in total

1.  Dual-fluorescence isogenic high-content screening for MUC16/CA125 selective agents.

Authors:  Thapi D Rao; Nestor Rosales; David R Spriggs
Journal:  Mol Cancer Ther       Date:  2011-08-04       Impact factor: 6.261

2.  Detection of somatic mutations in tumors using unaligned clonal sequencing data.

Authors:  Kate M Sutton; Laura A Crinnion; David Wallace; Sally Harrison; Paul Roberts; Christopher M Watson; Alexander F Markham; David T Bonthron; Philip Quirke; Ian M Carr
Journal:  Lab Invest       Date:  2014-07-28       Impact factor: 5.662

Review 3.  Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response.

Authors:  Hans-Georg Eichler; Eric Abadie; Alasdair Breckenridge; Bruno Flamion; Lars L Gustafsson; Hubert Leufkens; Malcolm Rowland; Christian K Schneider; Brigitte Bloechl-Daum
Journal:  Nat Rev Drug Discov       Date:  2011-07-01       Impact factor: 84.694

4.  Clinical trials in the era of personalized oncology.

Authors:  Michael L Maitland; Richard L Schilsky
Journal:  CA Cancer J Clin       Date:  2011-10-27       Impact factor: 508.702

5.  Cell Active Hydroxylactam Inhibitors of Human Lactate Dehydrogenase with Oral Bioavailability in Mice.

Authors:  Hans E Purkey; Kirk Robarge; Jinhua Chen; Zhongguo Chen; Laura B Corson; Charles Z Ding; Antonio G DiPasquale; Peter S Dragovich; Charles Eigenbrot; Marie Evangelista; Benjamin P Fauber; Zhenting Gao; Hongxiu Ge; Anna Hitz; Qunh Ho; Sharada S Labadie; Kwong Wah Lai; Wenfeng Liu; Yajing Liu; Chiho Li; Shuguang Ma; Shiva Malek; Thomas O'Brien; Jodie Pang; David Peterson; Laurent Salphati; Steve Sideris; Mark Ultsch; BinQing Wei; Ivana Yen; Qin Yue; Huihui Zhang; Aihe Zhou
Journal:  ACS Med Chem Lett       Date:  2016-08-26       Impact factor: 4.345

6.  Translational control of cell growth and malignancy by the CPEBs.

Authors:  Andrea D'Ambrogio; Kentaro Nagaoka; Joel D Richter
Journal:  Nat Rev Cancer       Date:  2013-02-28       Impact factor: 60.716

Review 7.  Optimal design of trials to demonstrate the utility of genomically-guided therapy: Putting Precision Cancer Medicine to the test.

Authors:  Rodrigo Dienstmann; Jordi Rodon; Josep Tabernero
Journal:  Mol Oncol       Date:  2014-07-15       Impact factor: 6.603

8.  Bayesian Two-stage Biomarker-based Adaptive Design for Targeted Therapy Development.

Authors:  Xuemin Gu; Nan Chen; Caimiao Wei; Suyu Liu; Vassiliki A Papadimitrakopoulou; Roy S Herbst; J Jack Lee
Journal:  Stat Biosci       Date:  2014-12-04

Review 9.  Somatic variation and cancer: therapies lost in the mix.

Authors:  Andrew V Biankin; Thomas J Hudson
Journal:  Hum Genet       Date:  2011-06-05       Impact factor: 5.881

10.  Assessing the efficacy of molecularly targeted agents on cell line-based platforms by using system identification.

Authors:  Xiangfang Li; Lijun Qian; Jianping Hua; Michael L Bittner; Edward R Dougherty
Journal:  BMC Genomics       Date:  2012-10-26       Impact factor: 3.969
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