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The study described here was the first to evaluate the dose, schedule, and pharmacokinetic profile of darbepoetin alpha in patients with anaemia of cancer, a condition for which dosing at weekly intervals or greater would be valuable.
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Based on the preclinical rationale for the combination of MK-2206 and trastuzumab, as well as promising preclinical results, we conducted a phase 1 trial to evaluate the QOD and QW dosing schedules from earlier trials and to determine the MTD and recommended phase 2 dose for MK-2206, administered in combination with standard doses of trastuzumab.
To evaluate the best dosing schedules, thirty-nine patients with locally advanced or metastatic HCC (Child-Pugh class A or B) were enrolled in an open-label phase 1 study and randomly assigned to daily (2.5 10 mg) or weekly (20 70 mg) everolimus in a standard 3 + 3 dose-escalation design.
With the dose schedule examined no antitumour effects were observed.
No significant QTc prolongations were observed, indicating that the dosing schedule evaluated in this study is safe.
This may also explain the dose scheduling observations.
In this systematic review, we included 21 RCTs and 9 retrospective studies to evaluate the optimal schedule and dose of BCG for preventing recurrence and progression of superficial BCa.
TTP was the primary activity endpoint in the study by Demetri and colleagues evaluating the two dosing schedules of trabectedin [ 22- 26].
The ongoing RTOG 1005 trial will evaluate a hypofractionated dose schedule with SIB compared to a standard treatment schedule with sequential boost.
The dosing schedule was appropriate in 32 cases (71%) only.
The dosing schedule is shown in Figure 1.
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