Literature DB >> 25940721

Scientific Review of Phase I Protocols With Novel Dose-Escalation Designs: How Much Information Is Needed?

Alexia Iasonos1, Mithat Gönen2, George J Bosl2.   

Abstract

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Year:  2015        PMID： 25940721      PMCID： PMC4962621          DOI： 10.1200/JCO.2014.59.8466

Source DB:  PubMed          Journal:  J Clin Oncol        ISSN： 0732-183X            Impact factor:   44.544


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  19 in total

1.  Dose-escalation models for combination phase I trials in oncology.

Authors:  Paul Hamberg; Mark J Ratain; Emmanuel Lesaffre; Jaap Verweij
Journal:  Eur J Cancer       Date:  2010-08-04       Impact factor: 9.162

2.  Continual reassessment method: a likelihood approach.

Authors:  J O'Quigley; L Z Shen
Journal:  Biometrics       Date:  1996-06       Impact factor: 2.571

Review 3.  Adaptive dose-finding studies: a review of model-guided phase I clinical trials.

Authors:  Alexia Iasonos; John O'Quigley
Journal:  J Clin Oncol       Date:  2014-06-30       Impact factor: 44.544

4.  Some practical improvements in the continual reassessment method for phase I studies.

Authors:  S N Goodman; M L Zahurak; S Piantadosi
Journal:  Stat Med       Date:  1995-06-15       Impact factor: 2.373

5.  Defining dose-limiting toxicity for phase 1 trials of molecularly targeted agents: results of a DLT-TARGETT international survey.

Authors:  Xavier Paoletti; Christophe Le Tourneau; Jaap Verweij; Lillian L Siu; Lesley Seymour; Sophie Postel-Vinay; Laurence Collette; Elisa Rizzo; Percy Ivy; David Olmos; Christophe Massard; Denis Lacombe; Stan B Kaye; Jean-Charles Soria
Journal:  Eur J Cancer       Date:  2014-06-10       Impact factor: 9.162

Review 6.  Choice of starting dose for molecularly targeted agents evaluated in first-in-human phase I cancer clinical trials.

Authors:  Christophe Le Tourneau; Anastasios Stathis; Laura Vidal; Malcolm J Moore; Lillian L Siu
Journal:  J Clin Oncol       Date:  2010-02-01       Impact factor: 44.544

7.  Simple benchmark for complex dose finding studies.

Authors:  Ying Kuen Cheung
Journal:  Biometrics       Date:  2014-02-25       Impact factor: 2.571

8.  Cancer phase I clinical trials: efficient dose escalation with overdose control.

Authors:  J Babb; A Rogatko; S Zacks
Journal:  Stat Med       Date:  1998-05-30       Impact factor: 2.373

9.  Phase I study of the antiangiogenic antibody bevacizumab and the mTOR/hypoxia-inducible factor inhibitor temsirolimus combined with liposomal doxorubicin: tolerance and biological activity.

Authors:  John Moroney; Siqing Fu; Stacy Moulder; Gerald Falchook; Thorunn Helgason; Charles Levenback; David Hong; Aung Naing; Jennifer Wheler; Razelle Kurzrock
Journal:  Clin Cancer Res       Date:  2012-08-27       Impact factor: 12.531

10.  Continual reassessment method for ordered groups.

Authors:  John O'Quigley; Xavier Paoletti
Journal:  Biometrics       Date:  2003-06       Impact factor: 2.571
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  17 in total

1.  Performance of toxicity probability interval based designs in contrast to the continual reassessment method.

Authors:  Bethany Jablonski Horton; Nolan A Wages; Mark R Conaway
Journal:  Stat Med       Date:  2016-07-19       Impact factor: 2.373

2.  Flexible Phase I-II design for partially ordered regimens with application to therapeutic cancer vaccines.

Authors:  Nolan A Wages; Craig L Slingluff
Journal:  Stat Biosci       Date:  2019-06-04

3.  Implementation of a Model-Based Design in a Phase Ib Study of Combined Targeted Agents.

Authors:  Nolan A Wages; Craig A Portell; Michael E Williams; Mark R Conaway; Gina R Petroni
Journal:  Clin Cancer Res       Date:  2017-07-21       Impact factor: 12.531

4.  Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies.

Authors:  N A Wages; C L Slingluff; G R Petroni
Journal:  Ann Oncol       Date:  2017-04-01       Impact factor: 32.976

Review 5.  Implementation of adaptive methods in early-phase clinical trials.

Authors:  Gina R Petroni; Nolan A Wages; Gautier Paux; Frédéric Dubois
Journal:  Stat Med       Date:  2016-02-29       Impact factor: 2.373

6.  Coherence principles in interval-based dose finding.

Authors:  Nolan A Wages; Alexia Iasonos; John O'Quigley; Mark R Conaway
Journal:  Pharm Stat       Date:  2019-11-06       Impact factor: 1.894

7.  Tailoring early-phase clinical trial design to address multiple research objectives.

Authors:  Nolan A Wages; Craig L Slingluff; Timothy N Bullock; Gina R Petroni
Journal:  Cancer Immunol Immunother       Date:  2019-12-05       Impact factor: 6.968

8.  A web application for evaluating Phase I methods using a non-parametric optimal benchmark.

Authors:  Nolan A Wages; Nikole Varhegyi
Journal:  Clin Trials       Date:  2017-06-24       Impact factor: 2.486

9.  Dimension of model parameter space and operating characteristics in adaptive dose-finding studies.

Authors:  Alexia Iasonos; Nolan A Wages; Mark R Conaway; Ken Cheung; Ying Yuan; John O'Quigley
Journal:  Stat Med       Date:  2016-04-18       Impact factor: 2.373

10.  Revisiting isotonic phase I design in the era of model-assisted dose-finding.

Authors:  Nolan A Wages; Mark R Conaway
Journal:  Clin Trials       Date:  2018-08-13       Impact factor: 2.486
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