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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Cancer
  • Clinical Oncology
  • Dermatofibrosarcoma
  • Ewing's Sarcoma
  • Ewing's Tumor
  • Fibrosarcoma
  • Histiocytoma
  • Malignant Melanoma
  • Melanoma
  • Neoplasia
  • Neoplasm
  • Neoplasms
  • Neuroblastoma
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Oncology, Medical
  • Osteogenic Sarcoma
  • Osteosarcoma
  • Osteosarcoma Tumor
  • Pediatrics, Osteosarcoma
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Ewing
  • Sarcoma, Ewing's
  • Sarcoma, Osteogenic
  • Sarcoma, Soft Tissue
  • Sarcoma, Spindle Cell
  • Sarcomas, Epitheliod
  • Tumors

NCT number NCT01962103
Study type Interventional
Source Celgene
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 4, 2013
Completion date November 6, 2018

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