Cancer Clinical Trial
Official title:
A Phase 1/2, Multicenter, Open-label, Dose-finding Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent or Refractory Solid Tumors.
The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in Phase 1 ≤ 18 years old and in Phase 2 ≤ 24 years old). After the final dose has been chosen, patients will be enrolled according to the specific solid tumor type, (neuroblastoma, rhabdomyosarcoma, or Ewing's sarcoma), to see how nab-paclitaxel works in treating these tumors.
ABI-007-PST-001 is a Phase 1/2, multicenter, open-label, dose-finding study to assess the
safety , tolerability, and preliminary efficacy of weekly nab-paclitaxel in pediatric
patients with recurrent or refractory solid tumors (excluding brain tumors). The Phase 1
portion of the study, with a dose escalation design, ended and the recommended Phase 2 dose
(RP2D) was determined as 240 mg/m^2 intravenously (IV) in patients weighing > 10 kg and 11.5
mg/kg in patients weighing ≤ 10 kg, on Days 1, 8 and 15 of a 28-day cycle. The Phase 2
portion of the study will enroll additional patients at the RP2D into 1 of 3 solid tumor
groups [neuroblastomas, rhabdomyosarcomas, Ewing's sarcomas]. Both phases of the study are
open-label and conducted at multiple centers.
The Phase 2 is using a Simon 2-stage design to monitor patient enrollment for each group
separately. The rhabdomyosarcoma group, neuroblastoma or Ewing's sarcoma groups did not reach
the expected number of 2 responders out of 14 efficacy eligible patients. Consequently, the
groups were stopped.
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