The benefits of including expansion cohorts in Phase I oncology clinical trial design

Aaron R Hansen; Albiruni RA Razak

doi:10.4155/cli.14.40

The benefits of including expansion cohorts in Phase I oncology clinical trial design

Clinical Investigation ◽

10.4155/cli.14.40 ◽

2014 ◽

Vol 4 (6) ◽

pp. 481-482

Author(s):

Aaron R Hansen ◽

Albiruni RA Razak

Keyword(s):

Clinical Trial ◽

Phase I ◽

Trial Design ◽

Clinical Trial Design ◽

Oncology Clinical Trial

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Phase I/II clinical trial design for a novel therapy for mucopolysaccharidosis type I with an intravenously administered blood-brain barrier-crossing enzyme (JR-171)

Molecular Genetics and Metabolism ◽

10.1016/j.ymgme.2020.12.105 ◽

2021 ◽

Vol 132 (2) ◽

pp. S49

Author(s):

Ryo Higurashi ◽

Mika Okazaki ◽

Satoshi Kawashima ◽

Toshiaki Ikeda ◽

Sairei So ◽

...

Keyword(s):

Clinical Trial ◽

Phase I ◽

Blood Brain Barrier ◽

Trial Design ◽

Clinical Trial Design ◽

Brain Barrier ◽

Type I ◽

Mucopolysaccharidosis Type ◽

Mucopolysaccharidosis Type I ◽

Novel Therapy

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Is the “3+3” Dose-Escalation Phase I Clinical Trial Design Suitable for Therapeutic Cancer Vaccine Development? A Recommendation for Alternative Design

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-13-2671 ◽

2014 ◽

Vol 20 (18) ◽

pp. 4758-4767 ◽

Cited By ~ 25

Author(s):

Osama E. Rahma ◽

Emily Gammoh ◽

Richard M. Simon ◽

Samir N. Khleif

Keyword(s):

Clinical Trial ◽

Phase I ◽

Cancer Vaccine ◽

Dose Escalation ◽

Trial Design ◽

Vaccine Development ◽

Clinical Trial Design ◽

Phase I Clinical Trial ◽

Therapeutic Cancer Vaccine ◽

Alternative Design

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Innovation in oncology clinical trial design

Cancer Treatment Reviews ◽

10.1016/j.ctrv.2019.01.001 ◽

2019 ◽

Vol 74 ◽

pp. 15-20 ◽

Cited By ~ 10

Author(s):

J. Verweij ◽

H.R. Hendriks ◽

H. Zwierzina ◽

Hanauske ◽

V. Wacheck ◽

...

Keyword(s):

Clinical Trial ◽

Trial Design ◽

Clinical Trial Design ◽

Oncology Clinical Trial

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Early 3+3 Trial Dose-Escalation Phase I Clinical Trial Design and Suitability for Immune Checkpoint Inhibitors

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-20-2669 ◽

2020 ◽

Author(s):

Osama E. Rahma ◽

Joshua E. Reuss ◽

Anita Giobbie-Hurder ◽

Ghazaleh Shoja E Razavi ◽

Osama Abu-Shawer ◽

...

Keyword(s):

Clinical Trial ◽

Phase I ◽

Dose Escalation ◽

Immune Checkpoint ◽

Trial Design ◽

Immune Checkpoint Inhibitors ◽

Checkpoint Inhibitors ◽

Clinical Trial Design ◽

Phase I Clinical Trial

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Adaptive Phase I clinical trial design using Markov models for conditional probability of toxicity

Journal of Biopharmaceutical Statistics ◽

10.1080/10543406.2015.1052492 ◽

2015 ◽

Vol 26 (3) ◽

pp. 475-498 ◽

Cited By ~ 4

Author(s):

Laura L. Fernandes ◽

Jeremy M. G. Taylor ◽

Susan Murray

Keyword(s):

Clinical Trial ◽

Phase I ◽

Conditional Probability ◽

Trial Design ◽

Markov Models ◽

Clinical Trial Design ◽

Phase I Clinical Trial

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Operating characteristics of the standard phase I clinical trial design

Computational Statistics & Data Analysis ◽

10.1016/s0167-9473(98)00095-4 ◽

1999 ◽

Vol 30 (3) ◽

pp. 303-315 ◽

Cited By ~ 69

Author(s):

Ethan Reiner ◽

Xavier Paoletti ◽

John O'Quigley

Keyword(s):

Clinical Trial ◽

Phase I ◽

Trial Design ◽

Clinical Trial Design ◽

Phase I Clinical Trial ◽

Operating Characteristics

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Recommended changes to oncology clinical trial design: Revolution or evolution?

European Journal of Cancer ◽

10.1016/j.ejca.2007.09.011 ◽

2008 ◽

Vol 44 (1) ◽

pp. 8-11 ◽

Cited By ~ 28

Author(s):

Mark J. Ratain ◽

Rachel W. Humphrey ◽

Gary B. Gordon ◽

Gwen Fyfe ◽

Peter C. Adamson ◽

...

Keyword(s):

Clinical Trial ◽

Trial Design ◽

Clinical Trial Design ◽

Oncology Clinical Trial

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Immuno-oncology Clinical Trial Design: Limitations, Challenges, and Opportunities

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-16-3066 ◽

2017 ◽

Vol 23 (17) ◽

pp. 4992-5002 ◽

Cited By ~ 23

Author(s):

Christina S. Baik ◽

Eric H. Rubin ◽

Patrick M. Forde ◽

Janice M. Mehnert ◽

Deborah Collyar ◽

...

Keyword(s):

Clinical Trial ◽

Trial Design ◽

Clinical Trial Design ◽

Oncology Clinical Trial ◽

Challenges And Opportunities

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Rejoinder to “A hybrid phase I‐II/III clinical trial design allowing dose reoptimization in phase III”

Biometrics ◽

10.1111/biom.12991 ◽

2019 ◽

Vol 75 (2) ◽

pp. 389-391

Author(s):

Andrew G. Chapple ◽

Peter F. Thall

Keyword(s):

Clinical Trial ◽

Phase I ◽

Trial Design ◽

Clinical Trial Design ◽

Phase Iii

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New clinical research strategies in thoracic oncology: clinical trial design, adaptive, basket and umbrella trials, new end-points and new evaluations of response

European Respiratory Review ◽

10.1183/09059180.00004214 ◽

2014 ◽

Vol 23 (133) ◽

pp. 367-378 ◽

Cited By ~ 59

Author(s):

J. Menis ◽

B. Hasan ◽

B. Besse

Keyword(s):

Clinical Trial ◽

Clinical Research ◽

Trial Design ◽

Clinical Trial Design ◽

Research Strategies ◽

End Points ◽

Oncology Clinical Trial

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