A Phase I Dose Finding Study in Children With Solid Tumors Recurrent or Refractory to Standard Therapy

Pediatric Oncology Clinical Trial

Official title: A Multi-center, Open-label, Non-randomized, Phase I Dose Escalation Study of Regorafenib (BAY 73-4506) in Pediatric Subjects With Solid Malignant Tumors That Are Recurrent or Refractory to Standard Therapy

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Expansion Phase of the study:

Subjects must have relapsed/refractory RMS or a solid malignant tumor (Ewing sarcoma, hepatoblastoma, neuroblastoma and Wilms tumor). ;

Related Conditions & MeSH terms

• Neoplasms
• Pediatric Oncology

• NCT number: NCT02085148
• Study type: Interventional
• Source: Bayer
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2014
• Completion date: March 13, 2024