Eligibility criteria for phase I clinical trials: tight vs loose?

Cancer Chemotherapy and Pharmacology
Laeeq Malik, David Lu

Abstract

The purpose of the current study is to analyze a series of phase I cancer clinical trials, examine and compare trial protocols based on patients' eligibility criteria. We evaluated all dose escalation phase I trial protocols with accessible or published results performed at Institute for Drug Development, Cancer Therapy and Research Center (San Antonio) between 1991 and 2016. Study protocols were categorized as non-restrictive (NRP) or restrictive (RP) based on several eligibility parameters. Fisher's Exact and Chi-square tests were used to compare characteristics of NRP and RP. Of 284 protocols screened, 231 dose escalation phase I trial protocols (with accessible results) of solid tumors were included in this review. There were 145 NRP (involving 3190 patients) and 86 RP (involving 1892 patients). The median number of exclusion criteria for NRP and RP were 14 and 23, respectively. The most common reasons that made trial protocol to be restrictive were ECOG ≤ 1, strict requirements for renal or hepatic function (≤ 2.5 times upper limit of normal) and exclusion of subjects with brain metastases. The median accrual time for NRP was significantly shorter as compared to RP (17 vs 26 months). The median number of dose levels explor...Continue Reading

References

Jan 1, 1981·Cancer·A B MillerA Winkler
Mar 17, 2001·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·P N LaraK S Lam
Dec 23, 2008·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·E A EisenhauerJ Verweij
Sep 26, 2014·Journal of the National Cancer Institute·David E GerberSandi L Pruitt
Dec 31, 2015·Journal of the National Cancer Institute·Caroline S BennetteDavid L Veenstra
Oct 3, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Edward S KimRichard L Schilsky
Nov 18, 2018·Investigational New Drugs·Laeeq Malik, David Lu

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Citations

Jul 9, 2020·Clinical Pharmacology and Therapeutics·Nam Atiqur RahmanJulia A Beaver
Feb 11, 2021·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Edward S KimRichard L Schilsky
Feb 11, 2021·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·R Donald HarveyEdward S Kim

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