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- W2600839870 abstract "2552 Background: The primary objective of phase I clinical trials is to evaluate the tolerability and pharmacokinetics of a new agent. Phase I trials in oncology remain ethically controversial. Our previous analysis from year 1991 through 2002 reported a response rate of 10.6 percent and a toxicity-related death rate of 0.49 percent. An increasing number of molecular targeted agents are under investigation and these results may not reflect current phase I oncology trials. Methods: We reviewed all non-pediatric phase 1 oncology trials sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute between January 1, 2001 and December 31, 2012. We report the rates of response to treatment, of stable disease, of grade 4 toxic events, and of treatment-related deaths. Results: We analyzed 286 trials, comprising 8314 participants. All 8314 participants were evaluated for toxic events, whereas 6604 participants were evaluated for response. The overall response rate (complete and partial respo..." @default.
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- W2600839870 date "2014-05-20" @default.
- W2600839870 modified "2023-09-26" @default.
- W2600839870 title "Risks and benefits of phase 1 oncology trials, 2001 through 2012." @default.
- W2600839870 doi "https://doi.org/10.1200/jco.2014.32.15_suppl.2552" @default.
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