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Phase I study with the DNA sequence-specific agent adozelesin

H A Burris1, V C Dieras, M Tunca

  • 1University of Texas Health Science Center at San Antonio, 78229, USA.

Anti-Cancer Drugs
|July 1, 1997
PubMed
Summary
This summary is machine-generated.

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Adozelesin, a novel cytotoxic agent, showed dose-limiting myelosuppression in a Phase I trial. The recommended Phase II dose for adozelesin is 150 microg/m2 intravenously every 4 weeks.

Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • Adozelesin is a synthetic analog of CC-1065, a potent antitumor antibiotic.
  • It functions as a cytotoxic agent by inhibiting DNA synthesis via minor groove binding.

Purpose of the Study:

  • To determine the recommended Phase II dose of adozelesin.
  • To characterize the toxic effects of adozelesin with a 10-minute intravenous infusion schedule.
  • To document any observed antitumor activity.

Main Methods:

  • A Phase I clinical trial was conducted with 47 adult patients having solid malignancies.
  • Adozelesin was administered intravenously every 6 weeks, with dose escalation using a modified Fibonacci scheme.
  • Myelosuppression was identified as the dose-limiting toxicity, with the maximally tolerated dose established at 180 microg/m2.

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Main Results:

  • The study escalated doses from 10 to 180 microg/m2.
  • Myelosuppression was the primary dose-limiting toxicity.
  • One patient with melanoma demonstrated a minor response lasting 4 months.

Conclusions:

  • The recommended Phase II dose for adozelesin is 150 microg/m2.
  • This dose should be administered as a 10-minute intravenous infusion every 4 weeks.