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The open-label study comprised a Baseline Phase, an Escalation Phase during which lamotrigine was titrated to a target dose, an 8-week Maintenance Phase during which doses of lamotrigine and concomitant antiepileptic drugs were maintained, and a 12-week Optimization Phase during which doses of lamotrigine and other antiepileptic drugs could be adjusted.
In accordance with the manufacturer's guidelines the treatment period was divided into two phases: a dose escalation phase of 20 days, and a maintenance phase of approximately two years.
It is made up of two phases: a dose escalation phase with 15 patients and an extended pivotal phase with an additional 55 patients.
The study consisted of two phases, a dose escalation phase meant to identify a RPTD and a biomarker expanded cohort at the RPTD, which was meant to better describe the effect of this regimen on several markers of angiogenesis.
A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of the Proteasome Inhibitor Carfilzomib (PR-171) in Patients with Hematological Malignancies.
De Wolf, K. et al. Combined high dose radiation and pazopanib in metastatic renal cell carcinoma: a phase I dose escalation trial.
OSI-930, a dual c-Kit and KDR tyrosine kinase inhibitor, is reported to have undergone a Phase I dose escalation study in patients with advanced solid tumors.
We present a Phase I dose escalation trial design based on a modified continual reassessment method that allows for sharing of information between populations.
Fig. 1 Immuno-PET signal components in a phase I dose escalation study.
MSCs reduced BPD severity and retinopathy of prematurity and improved inflammatory cytokine profile in tracheal aspirates in a phase 1 dose escalation study.
Based on these studies, we proposed a phase 1 dose escalation trial followed by a phase 2 randomized, double-blind, placebo-controlled clinical trial of human MSCs for the treatment of moderate-severe ARDS.
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