Literature DB >> 22407830

Choosing phase II endpoints and designs: evaluating the possibilities.

Michael LeBlanc1, Catherine Tangen.   

Abstract

Selecting the phase II design and endpoint to achieve the best possible chance of success for a confirmatory phase III study in a particular disease and treatment setting is challenging but critical. Simulating from existing clinical trial data sets and from mathematical models can be useful tools for evaluating statistical properties. ©2012 AACR.

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Year:  2012        PMID： 22407830      PMCID： PMC4820349          DOI： 10.1158/1078-0432.CCR-12-0454

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


  4 in total

1.  Resampling phase III data to assess phase II trial designs and endpoints.

Authors:  Manish R Sharma; Theodore G Karrison; Yuyan Jin; Robert R Bies; Michael L Maitland; Walter M Stadler; Mark J Ratain
Journal:  Clin Cancer Res       Date:  2012-01-27       Impact factor: 12.531

2.  More randomization in phase II trials: necessary but not sufficient.

Authors:  Lawrence Rubinstein; Michael Leblanc; Malcolm A Smith
Journal:  J Natl Cancer Inst       Date:  2011-06-27       Impact factor: 13.506

3.  Sorafenib in advanced clear-cell renal-cell carcinoma.

Authors:  Bernard Escudier; Tim Eisen; Walter M Stadler; Cezary Szczylik; Stéphane Oudard; Michael Siebels; Sylvie Negrier; Christine Chevreau; Ewa Solska; Apurva A Desai; Frédéric Rolland; Tomasz Demkow; Thomas E Hutson; Martin Gore; Scott Freeman; Brian Schwartz; Minghua Shan; Ronit Simantov; Ronald M Bukowski
Journal:  N Engl J Med       Date:  2007-01-11       Impact factor: 91.245

4.  Prognostic factors of metastatic renal cell carcinoma after failure of immunotherapy: new paradigm from a large phase III trial with shark cartilage extract AE 941.

Authors:  Bernard Escudier; Toni K Choueiri; Stéphane Oudard; Cezary Szczylik; Sylvie Négrier; Alain Ravaud; Christine Chevreau; Peter Venner; Pierre Champagne; Daniel Croteau; Eric Dupont; Claude Hariton; Ronald M Bukowski
Journal:  J Urol       Date:  2007-09-17       Impact factor: 7.450
  4 in total
  1 in total

1.  Clinical Utility of Metrics Based on Tumor Measurements in Phase II Trials to Predict Overall Survival Outcomes in Phase III Trials by Using Resampling Methods.

Authors:  Ming-Wen An; Yu Han; Jeffrey P Meyers; Jan Bogaerts; Daniel J Sargent; Sumithra J Mandrekar
Journal:  J Clin Oncol       Date:  2015-10-26       Impact factor: 44.544
  1 in total

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