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Activity Number:
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339
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Type:
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Contributed
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Date/Time:
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Wednesday, August 11, 2004 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302239 |
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Title:
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Phase I Trial Statistical Assessment of the Tetrameric Single-chain Anti-CD20
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Author(s):
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Kuang-Ho Chen*+
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Companies:
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University of Alabama, Birmingham
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Address:
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Dept. of Medicine, Birmingham, AL, 35294,
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Keywords:
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statistical efficacy assessment ; fusion estimate of pre-targeted tumor cells ; kinetics inference ; hypothesis testing on coefficient matrix ; linear system of ordinary differential equations
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Abstract:
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A Pretarget® Radioimmunotherapy of colorectal cancer in phase I trial under lower doses of B9E9FP and DOTA-Biotin with the short period before clearance has statistically confirmed not inferior than double dose of the tumor cell specificity fusing protein and/or the related antibody in the same or longer period. The kinetics of the targeted tumor cells fused by the specificity B9E9FP bound later by radiolabeled DOTA-Biotin has been statistically modeled for estimation and employed as an endpoint. The trial designed the four cohorts using combinations of loading concentrations of 160 and 320 mg/m2 of B9E9FP either mixed with 186Re-B9E9FP, of 1.3 and 0.65 mg/m2 of DOTA-Biotin, and 48 to 72 hours clearance durations for synthetic clearing agent. The confirmation is an application of the kinetic inference derived from the statistic compartment modeling with the Gaussian-type distribution. The distribution was empirically modeled from the noises induced from the treatment under the trial and the trial design. The modeling of the study is applicable to structuring a kinetic, not only for the current comparison.
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