Choice of starting dose and escalation for phase I studies of antitumor agents

John S. Penta, Gary Rosner, Donald L. Trump

Research output: Contribution to journalArticle

Abstract

The standard approaches to initial dose selection and dose escalation in phase I trials may be inappropriately conservative. These approaches mandate accrual of large numbers of patients, most of whom are treated at low and potentially ineffective doses. We compared the clinically determined maximum tolerable dose (MTD) with the starting dose of 45 drugs that had undergone phase I studies during the period 1977-1989. We also examined the number of dose-escalation steps required to achieve the MTD in relation to nonhematologic and hematologic dose-limiting toxicity. The median ratio of MTD to starting dose for all drugs was 20 (range,

Original languageEnglish (US)
Pages (from-to)247-250
Number of pages4
JournalCancer Chemotherapy and Pharmacology
Volume31
Issue number3
DOIs
StatePublished - May 1992
Externally publishedYes

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Antineoplastic Agents
Pharmaceutical Preparations
Toxicity

ASJC Scopus subject areas

  • Pharmacology
  • Oncology
  • Cancer Research

Cite this

Choice of starting dose and escalation for phase I studies of antitumor agents. / Penta, John S.; Rosner, Gary; Trump, Donald L.

In: Cancer Chemotherapy and Pharmacology, Vol. 31, No. 3, 05.1992, p. 247-250.

Research output: Contribution to journalArticle

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