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Last Updated: 04/25/2012

Testing a New Oncology Drug Development Paradigm - Section 4

The distinctive features of phase 0 studies are:

  • First-in-human, with single or combination drugs
  • Molecules from CCR, academia, small biotech
  • Small patient numbers (6–10); joint CCR-DCTD clinical trial effort performed in the Clinical Research Center
  • Provide PK/PD data to support rapid future dose escalation based on extensive preclinical toxicology and target effect studies
  • Initial target assay development and drug/target assessments (primary and surrogate, imaging and molecular expression)
  • Preliminary toxicity evaluation in humans
  • Inform subsequent broad phase I/II trials
  • High throughput of trials, each completed in three to six months
  • Preliminary toxicity evaluation in humans