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Activity Number:
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322
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Type:
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Contributed
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Date/Time:
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Tuesday, August 4, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biometrics Section
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| Abstract - #303602 |
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Title:
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'Dose-Establishment' Designs for Phase I/II Cancer Immunotherapy Trials
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Author(s):
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Karen Messer*+
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Companies:
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University of California, San Diego
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Address:
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Division of Biostatistics, La Jolla, CA, 92093-0901,
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Keywords:
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Phase I/II trial ; cancer ; clinical trial ; early phase trial ; oncology
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Abstract:
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A standard Phase I oncology trial is designed to find the maximum tolerated dose in a setting where serious drug-related toxicity is expected. However, some newer agents investigated for cancer immunotherapy hope to show efficacy without increasing the rate of adverse events. Our Phase I/II dose-establishment design is suitable when the therapeutic dose is expected to be well below the maximum tolerated dose. This design incorporates a likelihood ratio test of a safety hypothesis in Phase I, which serves as an interim safety analysis before proceeding to Phase II. The Phase I/II data are combined for an upper confidence limit on the toxicity rate at the therapeutic dose, using an exact method. We give an example from a Phase I/II trial of immunotherapy in leukemia. We also show how to compute the power, expected sample size, and expected number of dose limiting toxicities.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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