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Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors

NCT01962103 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2019-12-27

Study results available
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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.

Conditions

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

Interventions

DRUG

nab-paclitaxel

nab-paclitaxel 120-270 mg/m2 IV on Days 1, 8 and 15 of a 28-day cycle

DRUG

nab-paclitaxel

IV infusion

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Ileana Elias, M.D. · Celgene Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-04
Primary Completion
2017-12-05
Completion
2018-11-06

Countries

  • United States
  • Canada
  • France
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01962103 on ClinicalTrials.gov