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Phase I oncology clinical trials are designed to identify the optimal dose that will be recommended for phase II trials.
If no further DLT events will be seen, the second dose level will be recommended for phase II.
Therefore, the weekly FUFOX regimen can be recommended for phase III studies as well as a combination partner for new investigational drugs in phase I/II trials.
Second dose level (37.5 mg) If 0/3 patients exhibit DLT at the second dose level, then the second dose level will be recommended for phase II.
If at the final analysis a large enough reduction in 24 week HOMA-IR score is found, the corresponding active dose will be recommended for phase III.
If one or more further DLT events are seen the dose will not be escalated and no does will be recommended for phase II.
Similar(52)
Based on the known radiosensitizing effect of Topotecan, this dose is recommended for phase II testing.
A dose of 20 mg/m2 on a weekly schedule for 3 weeks of a 4 week cycle was established in a phase I dose escalation study; it was this dose schedule that was recommended for phase II trials in cancers with no established standard chemotherapy [26] and was chosen for this study.
Temozolomide 200 mg m−2 day−1 for 5 days, every 28 days, is recommended for phase II studies.
The dose level below the MTD was recommended for phase II evaluation.
The MTD, 200 mg QD, is recommended for phase II study.
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