Literature DB >> 19961955

Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development?

Craig P Carden1, Debashis Sarker, Sophie Postel-Vinay, Timothy A Yap, Gerthardt Attard, Udai Banerji, Michelle D Garrett, George V Thomas, Paul Workman, Stan B Kaye, Johann S de Bono.   

Abstract

Anticancer drug development remains slow, costly and inefficient. One way of addressing this might be the use of predictive biomarkers to select patients for Phase I/II trials. Such biomarkers, which predict response to molecular-targeted agents, have the potential to enrich these trials with patients more likely to benefit. Doing so could maximize the efficiency of anticancer drug development by facilitating earlier clinical qualification of predictive biomarkers and generating valuable information on cancer biology. In this review, we suggest a new model of early clinical trial design, which incorporates patient selection through predictive molecular biomarkers for selected targeted agents. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

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Year:  2009        PMID: 19961955     DOI: 10.1016/j.drudis.2009.11.006

Source DB:  PubMed          Journal:  Drug Discov Today        ISSN: 1359-6446            Impact factor:   7.851


  24 in total

Review 1.  Utilizing targeted cancer therapeutic agents in combination: novel approaches and urgent requirements.

Authors:  Shivanni Kummar; Helen X Chen; John Wright; Susan Holbeck; Myrtle Davis Millin; Joseph Tomaszewski; James Zweibel; Jerry Collins; James H Doroshow
Journal:  Nat Rev Drug Discov       Date:  2010-10-29       Impact factor: 84.694

Review 2.  Applications of liquid biopsy in the Pharmacological Audit Trail for anticancer drug development.

Authors:  Abhijit Pal; Rajiv Shinde; Manuel Selvi Miralles; Paul Workman; Johann de Bono
Journal:  Nat Rev Clin Oncol       Date:  2021-03-24       Impact factor: 66.675

3.  Bridging the gap: moving predictive and prognostic assays from research to clinical use.

Authors:  P Michael Williams; Tracy G Lively; J Milburn Jessup; Barbara A Conley
Journal:  Clin Cancer Res       Date:  2012-03-15       Impact factor: 12.531

4.  Targeting PI3K in Cancer: Any Good News?

Authors:  Miriam Martini; Elisa Ciraolo; Federico Gulluni; Emilio Hirsch
Journal:  Front Oncol       Date:  2013-05-08       Impact factor: 6.244

Review 5.  Design, synthesis, and evaluation of small molecule Hsp90 probes.

Authors:  Tony Taldone; Danuta Zatorska; Pallav D Patel; Hongliang Zong; Anna Rodina; James H Ahn; Kamalika Moulick; Monica L Guzman; Gabriela Chiosis
Journal:  Bioorg Med Chem       Date:  2011-03-12       Impact factor: 3.641

6.  Evaluation of the Safety and Benefit of Phase I Oncology Trials for Patients With Primary CNS Tumors.

Authors:  Mrinal M Gounder; Lakshmi Nayak; Solmaz Sahebjam; Alona Muzikansky; Armando J Sanchez; Serena Desideri; Xiaobu Ye; S Percy Ivy; L Burt Nabors; Michael Prados; Stuart Grossman; Lisa M DeAngelis; Patrick Y Wen
Journal:  J Clin Oncol       Date:  2015-08-17       Impact factor: 44.544

Review 7.  Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs.

Authors:  J Cummings; F Raynaud; L Jones; R Sugar; C Dive
Journal:  Br J Cancer       Date:  2010-10-05       Impact factor: 7.640

8.  A retrospective analysis of clinical outcome of patients with chemo-refractory metastatic breast cancer treated in a single institution phase I unit.

Authors:  A T Brunetto; D Sarker; D Papadatos-Pastos; R Fehrmann; S B Kaye; S Johnston; M Allen; J S De Bono; C Swanton
Journal:  Br J Cancer       Date:  2010-07-27       Impact factor: 7.640

9.  Molecular biomarker analyses using circulating tumor cells.

Authors:  Elizabeth A Punnoose; Siminder K Atwal; Jill M Spoerke; Heidi Savage; Ajay Pandita; Ru-Fang Yeh; Andrea Pirzkall; Bernard M Fine; Lukas C Amler; Daniel S Chen; Mark R Lackner
Journal:  PLoS One       Date:  2010-09-08       Impact factor: 3.240

Review 10.  Prognostic and predictive miRNA biomarkers in bladder, kidney and prostate cancer: Where do we stand in biomarker development?

Authors:  Maria Schubert; Kerstin Junker; Joana Heinzelmann
Journal:  J Cancer Res Clin Oncol       Date:  2015-12-12       Impact factor: 4.553

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