Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Tracking the poziotinib dosing changes for my sanity. The Korean patients rec’d 12 mg PO once daily for 14 days, followed by a 7 day treatment-free period and no laxative given. At the start of the US metastatic P2 breast cancer study, patients got twice the dose - 24 mg of poziotinib orally (as three 8-mg tablets) for 14 days, followed by a 7-day treatment-free period and laxative given. After 32 pts, this was revised to 16 mg of poziotinib orally (as two 8-mg tablets) given continuously plus laxative (ditto w the the lung cancer study). So, a question that comes to mind is after they revised the US mBC study to 16 mg/day down from 24 mg did they start the study over? I don’t think so since after the 3 week cycle an equivalent amount poziotinib was given (336 mg) and I don’t see anything on the clinical trials site to indicate anything differently. However, I’m sure they’ll keep tract of those 32 pts to see if they can detect any differences.