Extract

- 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.

Inclusion criteria

• Pediatric patients with solid malignant tumors that are recurrent or refractory to standard therapy

Links

• ictrp
• euctr