Dose escalation phase of the study : To define the safety profile, maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of regorafenib administered orally as a single agent in a 3-weeks-on/1- week-off schedule in repeating cycles of 28 days in pediatric subjects with solid malignant tumors recurrent or refractory to standard therapy. To characterize the pharmacokinetics (PK) of regorafenib The dose escalation phase of the study has been completed. Expansion phase: To define the safety profile, MTD and the RP2D of regorafenib administered orally in combination with backbone chemotherapy (vincristine and irinotecan) at relapse in pediatric subjects with rhabdomyosarcoma (RMS) and other solid malignant tumors recurrent or refractory to standard therapy.
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Safety: Maximum Tolerated Dose
Timeframe: approximately after 21 months
Safety: Recommended Phase II Dose
Timeframe: approximately after 21 months
Number of participants with Adverse Events
Timeframe: Dose escalation phase:approximately after 21 months; Expansion Phase: approximately after 21 months
AUC(0-24)md based on nominal dosing
Timeframe: Dose escalation phase:Cycle 1 Day 1, Day 15 and Day 21