Literature DB >> 26441082

Clinical trials: Early phase clinical trials-are dose expansion cohorts needed?

Alexia Iasonos1, John O'Quigley2.   

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Year:  2015        PMID： 26441082      PMCID： PMC4758199          DOI： 10.1038/nrclinonc.2015.174

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


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  9 in total

1.  Dose-finding designs for HIV studies.

Authors:  J O'Quigley; M D Hughes; T Fenton
Journal:  Biometrics       Date:  2001-12       Impact factor: 2.571

2.  Challenges and pitfalls of combining targeted agents in phase I studies.

Authors:  Stephen A Cannistra
Journal:  J Clin Oncol       Date:  2008-08-01       Impact factor: 44.544

3.  Design considerations for dose-expansion cohorts in phase I trials.

Authors:  Alexia Iasonos; John O'Quigley
Journal:  J Clin Oncol       Date:  2013-10-07       Impact factor: 44.544

Review 4.  Evolution of clinical trial design in early drug development: systematic review of expansion cohort use in single-agent phase I cancer trials.

Authors:  Arif Manji; Irene Brana; Eitan Amir; George Tomlinson; Ian F Tannock; Philippe L Bedard; Amit Oza; Lillian L Siu; Albiruni R Abdul Razak
Journal:  J Clin Oncol       Date:  2013-10-14       Impact factor: 44.544

5.  Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial.

Authors:  Robert J Motzer; Brian I Rini; David F McDermott; Bruce G Redman; Timothy M Kuzel; Michael R Harrison; Ulka N Vaishampayan; Harry A Drabkin; Saby George; Theodore F Logan; Kim A Margolin; Elizabeth R Plimack; Alexandre M Lambert; Ian M Waxman; Hans J Hammers
Journal:  J Clin Oncol       Date:  2014-12-01       Impact factor: 44.544

6.  Survival, Durable Response, and Long-Term Safety in Patients With Previously Treated Advanced Renal Cell Carcinoma Receiving Nivolumab.

Authors:  David F McDermott; Charles G Drake; Mario Sznol; Toni K Choueiri; John D Powderly; David C Smith; Julie R Brahmer; Richard D Carvajal; Hans J Hammers; Igor Puzanov; F Stephen Hodi; Harriet M Kluger; Suzanne L Topalian; Drew M Pardoll; Jon M Wigginton; Georgia D Kollia; Ashok Gupta; Dan McDonald; Vindira Sankar; Jeffrey A Sosman; Michael B Atkins
Journal:  J Clin Oncol       Date:  2015-03-30       Impact factor: 44.544

7.  Safety, activity, and immune correlates of anti-PD-1 antibody in cancer.

Authors:  Suzanne L Topalian; F Stephen Hodi; Julie R Brahmer; Scott N Gettinger; David C Smith; David F McDermott; John D Powderly; Richard D Carvajal; Jeffrey A Sosman; Michael B Atkins; Philip D Leming; David R Spigel; Scott J Antonia; Leora Horn; Charles G Drake; Drew M Pardoll; Lieping Chen; William H Sharfman; Robert A Anders; Janis M Taube; Tracee L McMiller; Haiying Xu; Alan J Korman; Maria Jure-Kunkel; Shruti Agrawal; Daniel McDonald; Georgia D Kollia; Ashok Gupta; Jon M Wigginton; Mario Sznol
Journal:  N Engl J Med       Date:  2012-06-02       Impact factor: 91.245

8.  Continual reassessment method vs. traditional empirically based design: modifications motivated by Phase I trials in pediatric oncology by the Pediatric Brain Tumor Consortium.

Authors:  Arzu Onar; Mehmet Kocak; James M Boyett
Journal:  J Biopharm Stat       Date:  2009       Impact factor: 1.051

9.  Bridging Solutions in Dose Finding Problems.

Authors:  John O'Quigley; Alexia Iasonos
Journal:  Stat Biopharm Res       Date:  2014-05-01       Impact factor: 1.452
  9 in total
  13 in total

1.  Integrating the escalation and dose expansion studies into a unified Phase I clinical trial.

Authors:  Alexia Iasonos; John O'Quigley
Journal:  Contemp Clin Trials       Date:  2016-07-05       Impact factor: 2.226

Review 2.  Evaluating the role of phase I expansion cohorts in oncologic drug development.

Authors:  Robin E Norris; Mohadese Behtaj; Pingfu Fu; Afshin Dowlati
Journal:  Invest New Drugs       Date:  2016-10-07       Impact factor: 3.850

Review 3.  Overcoming obstacles in the design of cancer anorexia/weight loss trials.

Authors:  Jennifer G Le-Rademacher; Jeffrey Crawford; William J Evans; Aminah Jatoi
Journal:  Crit Rev Oncol Hematol       Date:  2017-06-24       Impact factor: 6.312

Review 4.  The European Organization for Research and Treatment of Cancer perspective on designing clinical trials with immune therapeutics.

Authors:  Jessica Menis; Saskia Litière; Konstantinos Tryfonidis; Vassilis Golfinopoulos
Journal:  Ann Transl Med       Date:  2016-07

5.  Sequential monitoring of Phase I dose expansion cohorts.

Authors:  Alexia Iasonos; John O'Quigley
Journal:  Stat Med       Date:  2016-02-07       Impact factor: 2.373

6.  The Impact of Early-Phase Trial Design in the Drug Development Process.

Authors:  Mark R Conaway; Gina R Petroni
Journal:  Clin Cancer Res       Date:  2018-10-16       Impact factor: 12.531

7.  A latent variable model for improving inference in trials assessing the effect of dose on toxicity and composite efficacy endpoints.

Authors:  James Ms Wason; Shaun R Seaman
Journal:  Stat Methods Med Res       Date:  2019-02-25       Impact factor: 3.021

8.  Use of Expansion Cohorts in Phase I Trials and Probability of Success in Phase II for 381 Anticancer Drugs.

Authors:  Diogo D G Bugano; Kenneth Hess; Denis L F Jardim; Alona Zer; Funda Meric-Bernstam; Lillian L Siu; Albiruni R A Razak; David S Hong
Journal:  Clin Cancer Res       Date:  2017-04-04       Impact factor: 12.531

9.  Statistical controversies in clinical research: building the bridge to phase II-efficacy estimation in dose-expansion cohorts.

Authors:  P S Boonstra; T M Braun; J M G Taylor; K M Kidwell; E L Bellile; S Daignault; L Zhao; K A Griffith; T S Lawrence; G P Kalemkerian; M J Schipper
Journal:  Ann Oncol       Date:  2017-07-01       Impact factor: 32.976

10.  Stopping rules for phase I clinical trials with dose expansion cohorts.

Authors:  Sean M Devlin; Alexia Iasonos; John O'Quigley
Journal:  Stat Methods Med Res       Date:  2021-12-24       Impact factor: 2.494
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