9P Late phase I studies: Concepts and outcomes of a new clinical trial design

Annals of Oncology ◽

10.1016/j.annonc.2021.08.2005 ◽

2021 ◽

Vol 32 ◽

pp. S1348

Author(s):

J.C. Benitez ◽

A. Geraud ◽

M. Texier ◽

C. Massard ◽

A. Paci ◽

...

Keyword(s):

Clinical Trial ◽

Phase I ◽

Trial Design ◽

Clinical Trial Design ◽

Phase I Studies

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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 ◽

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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 ◽

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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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 ◽

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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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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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 ◽

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

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 ◽

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Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design

Journal of Sexual Medicine ◽

10.1016/j.jsxm.2016.09.021 ◽

2016 ◽

Vol 13 (12) ◽

pp. 1805-1817

Author(s):

William A. Fisher ◽

Ilan Gruenwald ◽

Emmanuele A. Jannini ◽

Ahinoam Lev-Sagie ◽

Lior Lowenstein ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Sexual Dysfunction ◽

Phase I ◽

Trial Design ◽

Female Sexual Dysfunction ◽

Clinical Trial Design ◽

Male And Female ◽

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Proteomic profiling identifies molecular basis of adverse event to BPM31510 exposure: Rationale for comprehensive molecular pharmacodynamics (PD) in phase I clinical trial design

Annals of Oncology ◽

10.1093/annonc/mdz244.060 ◽

2019 ◽

Vol 30 ◽

pp. v188

Author(s):

V. Subbiah ◽

E. Granger ◽

M. Kiebish ◽

R. Zinner ◽

D.S. Hong ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Event ◽

Phase I ◽

Molecular Basis ◽

Trial Design ◽

Clinical Trial Design ◽

Phase I Clinical Trial ◽

Proteomic Profiling

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TSNP : A two‐stage nonparametric phase I/ II clinical trial design for immunotherapy

Pharmaceutical Statistics ◽

10.1002/pst.2075 ◽

2020 ◽

Author(s):

Yan Han ◽

Hao Liu ◽

Sha Cao ◽

Chi Zhang ◽

Yong Zang

Keyword(s):

Clinical Trial ◽

Phase I ◽

Trial Design ◽

Clinical Trial Design ◽

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