Abstract Details
Activity Number:
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293
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Type:
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Contributed
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Date/Time:
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Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #311670
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View Presentation
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Title:
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A Simulation-Based Comparison of Two Adaptive Designs in Phase I Dose Finding Oncology Trial
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Author(s):
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Xiaoling Wu*+ and Shaoyi Li
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Companies:
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Celgene Corporation and Celgene Corporation
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Keywords:
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Dose finding ;
rolling six ;
3+3 ;
MTD
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Abstract:
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Phase I dose finding trials in oncology are designed to find the highest dose at which the toxicity probability is less than a target threshold. Patients are enrolled sequentially and assigned a dose out of a pre-determined grid, based upon observed dose limiting toxicity. Two points are critical: completing enrollment briskly and finding an accurate MTD. Currently the most widely used study design is the "up and down" 3+3. The rolling six design is a relatively new alternative design aiming to shorten study duration. It allows for accrual of two to six patients concurrently onto a dose level based on the number of enrolled and evaluable patients. It is not yet established in adult studies however. This work will quantify performance of the 3+3 and rolling six designs to achieve the first goal while maintaining the second one, under a close to real world setting using simulated data. Metrics to be used include study duration, sample size, toxicity rate and MTD. Conclusion is that the rolling six design will outperform the 3+3 design in the first three factors under given settings. However its resultant MTD may vary from that of the 3+3 with no certain pattern.
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Authors who are presenting talks have a * after their name.
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