Methods
dose-limiting, toxicities, FIP
STD, FIP
An IQ DruSafe Working Group was formed to evaluate an alternative approach to setting starting doses in oncology FIP clinical studies. The scope was small molecule marketed MTA oncology drugs or those in clinical development that had reached an MTD/RP2D. A database was created capturing 50 fields of information for each of the 92 anonymized compounds provided by 12 pharmaceutical companies (AbbVie, AstraZeneca, Amgen, Boehringer Ingelheim, Bristol Meyers Squibb, Eisai, Eli Lilly, GlaxoSmithKline, Janssen, Merck, Novartis, and Pfizer). An additional 9 fields of data were collected for the alternative starting dose scenario exercise, for a total of 5428 data points. The information collected related to the compound attributes, and nonclinical and clinical safety data. These included general target class, nonclinical toxicology species, and toxicology or clinical study information. Nonclinical and clinical information included doses, exposures (AUC), dose-limiting target toxicities, NOAEL, STD