Spots Global Cancer Trial Database for A Phase I Dose Finding Study in Children With Solid Tumors Recurrent or Refractory to Standard Therapy

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Trial Identification

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

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

Study ID: NCT02085148

Conditions

Pediatric Oncology

Interventions

Regorafenib (BAY73-4506)

Vincristine (Cellcristin®)

Irinotecan (Irinotecan Cell pharm®)

Study Description

Brief 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.

Detailed Description: Expansion Phase of the study: Subjects must have relapsed/refractory RMS or a solid malignant tumor (Ewing sarcoma, hepatoblastoma, neuroblastoma and Wilms tumor).