Since the trial is the first-in-man study of the IMP, the dose escalation will be carried out in accordance to a sequential escalating design, including interims assessments of safety and tolerability after each dose level and between both study groups.
In this phase I study CG7870 was administered as a single intravenous infusion in a group-sequential dose escalation design (1 × 1010 to 6 × 1012 viral particles (vp)) to 23 patients with hormone-refractory metastatic prostate cancer.
Sequential de-escalation provides maximum benefit for the individual patient and reduces the selection pressure fueling the development of resistance.
This single-center, open-label, sequential dose-escalation study of lenvatinib was conducted at the National Cancer Center Hospital, Tokyo, Japan.
The study was performed in three sequential cohorts, and escalation between cohorts did not occur until the previous cohort had received two vaccinations and the safety data from this group had been reviewed by a Safety Monitoring Committee.
This was a two centre, phase I, dose-escalation, sequential cohort study.
A Phase I, open-label, sequential-group dose escalation study was conducted to assess the tolerability, safety, and pharmacokinetics of micafungin in pediatric patients with neutropenia.
In a phase I, dose-escalation, sequential cohort study in patients with advanced solid tumours (Isambert et al, 2011), aflibercept 6 mg kg−1 with docetaxel 75 mg m−2 every 3 weeks was established as the recommended phase II trial dose (RP2D).
Forty-eight participants consented, enrolled, and received their assigned injection at study entry between the months of April and September 2005, in two sequential groups to permit dose escalation.
Dose escalation by a sequential boost regimen results in a longer treatment duration.
