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Related Experiment Videos

Phase I study of NKT-01

K Tamura1, H Niitani, M Oguro

  • 1Miyazaki Prefectural Hospital, Japan.

Cancer Chemotherapy and Pharmacology
|January 1, 1995
PubMed
Summary

NKT-01 (deoxyspergualin), an antitumor antibiotic derivative, showed dose-dependent toxicities in a phase I trial. The recommended dose for solid tumors is 400 mg/m2 daily for 5 days.

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • NKT-01 (deoxyspergualin) is a derivative of the antitumor antibiotic spergualin.
  • Phase I clinical trials are essential for evaluating novel anti-cancer agents.

Purpose of the Study:

  • To assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of NKT-01 in patients with various malignancies.
  • To determine the maximum tolerated dose (MTD) and recommended dose for phase II studies.

Main Methods:

  • A cooperative group conducted a phase I study involving single and daily intravenous infusions of NKT-01.
  • Patients received doses ranging from 20 to 500 mg/m2.
  • Pharmacokinetic analysis and toxicity assessments were performed.

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Main Results:

  • No significant adverse effects were observed in single-dose studies up to 320 mg/m2.
  • Dose-dependent toxicities including myelosuppression, nausea, anorexia, alopecia, numbness, and hypotension were noted in daily administration.
  • The maximal acceptable dose was determined to be 500 mg/m2, with dose-limiting toxicities of perioral numbness, hypotension, and hematological toxicity.
  • A transient reduction in leukemic cells was observed in one patient with adult T-cell leukemia.

Conclusions:

  • NKT-01 is generally well-tolerated at lower doses, but exhibits dose-limiting toxicities at higher doses.
  • The recommended dose for phase II studies in solid tumors is 400 mg/m2 daily for 5 days.
  • Further investigation into higher myelosuppressive schedules is warranted for hematological malignancies.