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Tezacitabine Hoechst Marion Roussel.

K L Seley1

  • 1Georgia Institute of Technology, School of Chemistry and Biochemistry, Boggs Building, Atlanta, GA 30332-0400, USA. seley@chem-mail.chemistry.gatech.edu

Current Opinion in Investigational Drugs (London, England : 2000)
|March 16, 2001
PubMed
Summary

Tezacitabine, a deoxycytidine analog, is an irreversible ribonucleotide reductase inhibitor. While showing promise in early trials for solid tumors, it did not demonstrate significant standalone activity in non-small cell lung cancer.

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Area of Science:

  • Oncology
  • Pharmacology
  • Drug Development

Background:

  • Tezacitabine (MDL-101731, KW-2331, FMdC) is an antimetabolite deoxycytidine analog.
  • It functions as an irreversible ribonucleotide reductase inhibitor and DNA chain terminator.
  • Developed by Hoechst Marion Roussel, it is under development by Matrix and Kyowa for solid tumors.

Purpose of the Study:

  • To evaluate tezacitabine as a potential treatment for solid tumors, including colorectal and hematological cancers.
  • To assess the efficacy and tolerability of tezacitabine in various clinical trial settings.
  • To explore tezacitabine's potential in combination therapies for advanced cancers.

Main Methods:

  • Phase I and II clinical trials were conducted to assess tezacitabine's safety and efficacy.
  • Dose-escalation studies involved intravenous infusions at varying schedules and doses (16 to 630 mg/m2).
  • Combination studies with cisplatin and 5-FU were initiated.

Main Results:

  • Phase I trials in 70 patients indicated tezacitabine was well tolerated.
  • Indications of efficacy were observed in patients with various advanced solid tumors.
  • A Phase II trial in non-small cell lung cancer showed no meaningful standalone activity at the tested dose and regimen.

Conclusions:

  • Tezacitabine is a well-tolerated agent with observed efficacy signals in advanced solid tumors.
  • Further investigation is warranted, particularly in combination therapies.
  • Standalone efficacy in non-small cell lung cancer was not demonstrated in initial Phase II evaluations.

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