• Corpus ID: 18648350

Extending the TITE CRM to Multiple Outcomes with Application to a Phase 1 Clinical Trial in Canine Hemangiosarcoma

  title={Extending the TITE CRM to Multiple Outcomes with Application to a Phase 1 Clinical Trial in Canine Hemangiosarcoma},
  author={Joseph S. Koopmeiners and Jaime F. Modiano},
In traditional phase 1 oncology trials, the safety of a new chemotherapeutic agent is tested in a dose escalation study to identify the maximum tolerated dose, which is defined as the highest dose with acceptable toxicity. An alternate approach is to jointly model toxicity and efficacy and allow dose finding to be directed by a pre-specified trade-off between efficacy and toxicity. With this goal in mind, several phase 1 designs have been proposed to jointly model toxicity and efficacy in phase… 

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