Multi-institutional phase I trials of anticancer agents.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Afshin DowlatiPingfu Fu

Abstract

Physicians involved in the conduct of phase I studies of novel anticancer agents have raised concerns about the emergence of multi-institutional phase I trials and about using the optimal biologic dose (OBD) as an alternative to the maximum-tolerated dose (MTD) as the primary end point in early drug development. We sought to determine the factors associated with multi-institutional phase I studies and OBD determination. We reviewed all published phase I trials between January 1998 and June 2006 from two major clinical cancer journals. The following components from each trial were determined: number of participating sites, sponsor, nation where study was conducted, MTD or OBD established, number of patients accrued, mechanism of action of the studied agent, accrual time, and tumor type. We identified 463 trials. Fifty-six percent were performed in single institutions. Only 30% reported accrual time. The number of patients enrolled on single institution studies was significantly lower than on multi-institutional studies (P < .05), but there was no difference in accrual time. There was no association between the number of institutions and the sponsor or the mechanism of drug action. National Institutes of Health-sponsored trials e...Continue Reading

References

Feb 2, 2000·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·E A EisenhauerJ S Humphrey
Nov 1, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Anthony W TolcherEric K Rowinsky
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Citations

Dec 10, 2009·Investigational New Drugs·Afshin DowlatiPingfu Fu
Jun 11, 2010·Nature Reviews. Cancer·Timothy A YapJohann S de Bono
Oct 15, 2009·The Cancer Journal·Daniel S W TanPaul Workman
Aug 31, 2010·Future Oncology·Andre T BrunettoJohann S de Bono
Jun 26, 2014·Journal of the National Cancer Institute·Suzanne E DahlbergBruce E Johnson
Dec 24, 2014·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Daniel MorgenszternRamaswamy Govindan
Nov 11, 2015·Nature Reviews. Clinical Oncology·Kit Man WongS Gail Eckhardt
Apr 15, 2005·Cancer Detection and Prevention·Jackson OremScot C Remick
Aug 16, 2016·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Han Hsi WongSarah Halford
Apr 19, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jaap VerweijMaja de Jonge
Feb 23, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David OlmosStan B Kaye
Apr 1, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hendrik-Tobias ArkenauStan Kaye
Jul 6, 2018·Cancer·Suzanne E Dahlberg, Robert J Gray
May 21, 2015·American Society of Clinical Oncology Educational Book·Kit Man WongS Gail Eckhardt
Mar 4, 2021·Therapeutic Innovation & Regulatory Science·Takashi SawadaMamoru Narukawa

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