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- W2244906324 abstract "2518 Background: New drug development is a time- and resource-consuming process. Phase 1 trials constitute a major key- step of this development. Shortening the accrual time may improve this process. Methods: 292 published phase-1-trials were retrospectively reviewed to establish the determinants of accrual period of time (APT) using Log-rank test and then Cox Model. Results: Out of 292 trials (1997–2008), only 107 reports (36%) described the accrual time (median: 20 months, 5–72). Phase-2- recommended dose was established in 87 studies (81%). Most of studies investigated regimens included cytotoxic drugs (77%) or molecular targeted therapies (29%). Most of parameters did not significantly affect the APT: nature and number of investigated drugs, duration of treatment cycle, phase 1 dedicated to specific tumoral subtypes, number of centers, method of drug escalation (classical 3+3 vs. accelerated titration design), type of dose increment (modified Fibonacci method vs. others) and presence of expanded cohort at the phase-II-recommended dose. Under univariate analysis, two parameters shortened the APT: studies conducted in USA vs. other place (19 vs. 21 months, p=0.03) and regimen with more than 2 dose-escalated drugs (13 vs. 21 months, p=0.003). One parameter was significantly associated with longer APT: starting dose justified by animal toxicology data (first-in-man studies) vs. previous clinical trials (22 vs. 19 months, p=0.03). Cox model analysis retained only one determinant: starting dose justified by animal toxicology data: HR=4.07 [1.45- 11.42], p=0.047. Conclusions: Few parameters influence the APT in the dose-escalation phase-1 setting. Real first-in-man phase 1 studies based on starting dose estimated from animal toxicological data require longer APT. [Table: see text]" @default.
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- W2244906324 date "2009-05-20" @default.
- W2244906324 modified "2023-09-26" @default.
- W2244906324 title "Determinants of accrual period of time in dose escalating phase I trials" @default.
- W2244906324 doi "https://doi.org/10.1200/jco.2009.27.15_suppl.2518" @default.
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