Phase I design for completely or partially ordered treatment schedules

Area of Science:

• Oncology
• Clinical Trial Design
• Pharmacokinetics

Background:

• Current phase I oncology trial designs primarily focus on single-course therapy.
• In practice, multiple treatment schedules exist for a given dose, influencing toxicity.
• Toxicity probability depends on both dose amount and administration frequency.

Purpose of the Study:

• To develop a novel dose-schedule finding design for phase I oncology trials.
• To relax the assumption of monotonically increasing toxicity with schedule.
• To accommodate scenarios with known and unknown schedule orderings.

Main Methods:

• Developed a flexible dose-schedule finding design.
• Relaxed the assumption of monotonic toxicity increase with schedule.
• Designed for situations with known and unknown schedule orderings.

Main Results:

• The proposed design can be generalized to various scenarios of schedule ordering.
• Simulation results demonstrate the method's performance.
• Comparison with existing dose-schedule finding methodologies was conducted.

Conclusions:

• The new design offers a more realistic approach to dose and schedule optimization in phase I oncology trials.
• This method provides a valuable tool for complex treatment scenarios.
• Further research can explore its application in diverse clinical settings.