Literature DB >> 25091610

Targeted therapies: redefining the primary objective of phase I oncology trials.

Mark J Ratain1.   

Abstract

Cytotoxic agents are conventionally dosed on the basis of the maximum tolerated dose defined in phase I trials. A study assessing adverse events in over 2,000 patients treated with molecularly targeted agents suggests a need to redefine criteria for dosing of molecularly targeted agents, which should be based on randomized, dose-ranging phase II trials.

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Year:  2014        PMID： 25091610     DOI： 10.1038/nrclinonc.2014.135

Source DB:  PubMed          Journal:  Nat Rev Clin Oncol        ISSN： 1759-4774            Impact factor:   66.675


  6 in total

1.  The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo.

Authors:  Joel M Kremer; Bradley J Bloom; Ferdinand C Breedveld; John H Coombs; Mark P Fletcher; David Gruben; Sriram Krishnaswami; Rubén Burgos-Vargas; Bethanie Wilkinson; Cristiano A F Zerbini; Samuel H Zwillich
Journal:  Arthritis Rheum       Date:  2009-07

2.  Playing Russian roulette with tyrosine kinase inhibitors.

Authors:  R Z Szmulewitz; M J Ratain
Journal:  Clin Pharmacol Ther       Date:  2012-12-18       Impact factor: 6.875

3.  Ceritinib in ALK-rearranged non-small-cell lung cancer.

Authors:  Alice T Shaw; Dong-Wan Kim; Ranee Mehra; Daniel S W Tan; Enriqueta Felip; Laura Q M Chow; D Ross Camidge; Johan Vansteenkiste; Sunil Sharma; Tommaso De Pas; Gregory J Riely; Benjamin J Solomon; Juergen Wolf; Michael Thomas; Martin Schuler; Geoffrey Liu; Armando Santoro; Yvonne Y Lau; Meredith Goldwasser; Anthony L Boral; Jeffrey A Engelman
Journal:  N Engl J Med       Date:  2014-03-27       Impact factor: 91.245

4.  A randomised trial comparing two doses of the new selective aromatase inhibitor anastrozole (Arimidex) with megestrol acetate in postmenopausal patients with advanced breast cancer.

Authors:  W Jonat; A Howell; C Blomqvist; W Eiermann; G Winblad; C Tyrrell; L Mauriac; H Roche; S Lundgren; R Hellmund; M Azab
Journal:  Eur J Cancer       Date:  1996-03       Impact factor: 9.162

5.  Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma.

Authors:  Michael B Atkins; Manuel Hidalgo; Walter M Stadler; Theodore F Logan; Janice P Dutcher; Gary R Hudes; Young Park; Song-Heng Liou; Bonnie Marshall; Joseph P Boni; Gary Dukart; Matthew L Sherman
Journal:  J Clin Oncol       Date:  2004-03-01       Impact factor: 44.544

6.  Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly targeted agents--dose-Limiting Toxicity and Toxicity Assessment Recommendation Group for Early Trials of Targeted therapies, an European Organisation for Research and Treatment of Cancer-led study.

Authors:  Sophie Postel-Vinay; Laurence Collette; Xavier Paoletti; Elisa Rizzo; Christophe Massard; David Olmos; Camilla Fowst; Bernard Levy; Pierre Mancini; Denis Lacombe; Percy Ivy; Lesley Seymour; Christophe Le Tourneau; Lillian L Siu; Stan B Kaye; Jaap Verweij; Jean-Charles Soria
Journal:  Eur J Cancer       Date:  2014-05-28       Impact factor: 9.162
  6 in total
  11 in total

1.  Beyond the dose-limiting toxicity period: Dermatologic adverse events of patients on phase 1 trials of the Cancer Therapeutics Evaluation Program.

Authors:  Alexander Drilon; Anne A Eaton; Katja Schindler; Mrinal M Gounder; David R Spriggs; Pamela Harris; S Percy Ivy; Alexia Iasonos; Mario E Lacouture; David M Hyman
Journal:  Cancer       Date:  2016-02-24       Impact factor: 6.860

2.  American Society of Clinical Oncology policy statement update: the critical role of phase I trials in cancer research and treatment.

Authors:  Jeffrey S Weber; Laura A Levit; Peter C Adamson; Suanna Bruinooge; Howard A Burris; Michael A Carducci; Adam P Dicker; Mithat Gönen; Stephen M Keefe; Michael A Postow; Michael A Thompson; David M Waterhouse; Susan L Weiner; Lynn M Schuchter
Journal:  J Clin Oncol       Date:  2014-12-15       Impact factor: 44.544

3.  Redefining the primary objective of phase I oncology trials.

Authors:  Mark J Ratain
Journal:  Nat Rev Clin Oncol       Date:  2014-09-09       Impact factor: 66.675

4.  Taking a Measured Approach to Toxicity Data in Phase I Oncology Clinical Trials.

Authors:  Manish R Sharma; Mark J Ratain
Journal:  Clin Cancer Res       Date:  2015-10-14       Impact factor: 12.531

5.  Patient-centered dosing: oncologists' perspectives about treatment-related side effects and individualized dosing for patients with metastatic breast cancer (MBC).

Authors:  Anne L Loeser; Lucy Gao; Aditya Bardia; Mark E Burkard; Kevin M Kalinsky; Jeffrey Peppercorn; Hope S Rugo; Martha Carlson; Janice Cowden; Lesley Glenn; Julia Maues; Sheila McGlown; Andy Ni; Natalia Padron; Maryam Lustberg
Journal:  Breast Cancer Res Treat       Date:  2022-10-06       Impact factor: 4.624

6.  Toxicity Attribution in Phase I Trials: Evaluating the Effect of Dose on the Frequency of Related and Unrelated Toxicities.

Authors:  Anne Eaton; Alexia Iasonos; Mrinal M Gounder; Erika G Pamer; Alexander Drilon; Diana Vulih; Gary L Smith; S Percy Ivy; David R Spriggs; David M Hyman
Journal:  Clin Cancer Res       Date:  2015-08-31       Impact factor: 12.531

7.  Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer.

Authors:  Russell Z Szmulewitz; Cody J Peer; Abiola Ibraheem; Elia Martinez; Mark F Kozloff; Bradley Carthon; R Donald Harvey; Paul Fishkin; Wei Peng Yong; Edmund Chiong; Chadi Nabhan; Theodore Karrison; William D Figg; Walter M Stadler; Mark J Ratain
Journal:  J Clin Oncol       Date:  2018-03-28       Impact factor: 50.717

8.  Model of a Queuing Approach for Patient Accrual in Phase 1 Oncology Studies.

Authors:  Paul H Frankel; Vincent Chung; Joseph Tuscano; Tanya Siddiqi; Sagus Sampath; Jeffrey Longmate; Susan Groshen; Edward M Newman
Journal:  JAMA Netw Open       Date:  2020-05-01

Review 9.  Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology.

Authors:  Brian P Hobbs; Pedro C Barata; Yada Kanjanapan; Channing J Paller; Jane Perlmutter; Gregory R Pond; Tatiana M Prowell; Eric H Rubin; Lesley K Seymour; Nolan A Wages; Timothy A Yap; David Feltquate; Elizabeth Garrett-Mayer; William Grossman; David S Hong; S Percy Ivy; Lillian L Siu; Steven A Reeves; Gary L Rosner
Journal:  J Natl Cancer Inst       Date:  2019-02-01       Impact factor: 13.506

Review 10.  Challenges and Opportunities in Dose Finding in Oncology and Immuno-oncology.

Authors:  Yan Ji; Jin Y Jin; David M Hyman; Geoffrey Kim; Ajit Suri
Journal:  Clin Transl Sci       Date:  2018-02-01       Impact factor: 4.689
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