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Development of target-based antineoplastic agents.

W M Stadler1, M J Ratain

  • 1Department of Medicine, University of Chicago, IL 60637, USA.

Investigational New Drugs
|June 1, 2000
PubMed
Summary
This summary is machine-generated.

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Designing clinical trials for novel cancer therapies presents challenges. New agents may be cytostatic, requiring innovative trial designs beyond traditional tumor shrinkage assessments.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Pharmacology

Background:

  • Multiple targets in cancer cells necessitate novel antineoplastic agents.
  • Many new agents exhibit cytostatic rather than cytotoxic effects.
  • Traditional endpoints like tumor shrinkage may be insufficient for cytostatic agents.

Purpose of the Study:

  • To address challenges in clinical trial design for multi-target antineoplastic agents.
  • To discuss issues in preclinical and clinical testing (Phases I-III) of these agents.
  • To propose suitable clinical trial designs for cytostatic antineoplastic agents.

Main Methods:

  • Review of challenges in clinical trial design for novel antineoplastic agents.
  • Discussion of ethical and safety considerations for tumor biopsies.

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  • Proposal of specific trial designs, including randomized discontinuation designs.

    • Main Results:

    • Current trial designs and endpoints may not adequately assess cytostatic agents.
    • Ethical and safety concerns limit repeated tumor biopsies.
    • Randomized discontinuation designs show promise for evaluating cytostatic agents in Phase II.

    Conclusions:

    • Clinical trial design for multi-target antineoplastic agents requires adaptation.
    • Alternative endpoints and designs are crucial for evaluating cytostatic therapies.
    • Innovative trial strategies can improve the assessment of novel cancer treatments.