Abstract
Following the determination of drug pharmacology, tolerability, and maximum tolerated dose (MTD) in Phase I trials, investigational drugs usually proceed to Phase II trials. As succinctly summarized by the FDA (21 CFR 312.21) [1], these trials are “conducted to (a) evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and (b) determine the common short-term side effects and risks associated with the drug. Phase II studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually not more than several hundred subjects.” Phase II trials act as a filter, helping to determine which of the investigational drugs emerging from Phase I testing are sufficiently effective to warrant further assessment in definitive Phase III trial.
Keywords
- Objective Response Rate
- Adenoid Cystic Carcinoma
- Experimental Agent
- Tumor Marker Level
- Investigational Agent
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
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Gan, H.K., Lee, J.J., Siu, L.L. (2011). Phase II Trials with Anticancer Agents. In: Garrett-Mayer, E. (eds) Principles of Anticancer Drug Development. Cancer Drug Discovery and Development. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-7358-0_6
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