In phase-I, PEG-Dox was administered in a 3-by-3 dose-escalation regimen.
Thus, the intra-patient dose-escalation regimen may prove beneficial to future trials with tasquinimod.
Phase I studies follow a dose-escalation regimen designed to determine the maximum tolerable dose (MTD).
In the PC-3M xenograft study, using MSeA in a dose-escalation regimen our data demonstrate a decrease in tumor volume, tumor burden, and tumor weights.
If a method of identifying patients who have a high risk of local failure could be identified, a dose-escalation regimen that allows a higher rate of treatment-associated toxicity may be seen as worthwhile.
Given the small sample size in the intra-patient dose-escalation group, it is not possible to provide a precise estimate, but the intra-patient dose-escalation regimen seemed to decrease the number of related adverse events per patient per month.
Sensitivity analyses were also conducted assuming lower discontinuation rates, as the Cochrane reviews present evidence of modified dose-escalation regimens for each of the three therapies leading to significantly fewer drop-outs over the trial periods.
Complete resolution of subcutaneous melanoma and nodules was achieved after a dose-escalation Gleevec regimen [34].
