CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
nab-paclitaxel +1 moredrug
Likely dose
nab-paclitaxel 270 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01962103
NCT01962103Phase 2Completed
CompareCT.gov

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.

Celgene·interventional·Posted Oct 14, 2013·Updated Dec 27, 2019

In Brief

A Phase 2 clinical trial evaluating nab-paclitaxel for Neuroblastoma and 22 related conditions. Completed, enrolled 107 participants across 20 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroblastoma, 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
CountriesCanada, France, Italy, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 14, 2013
Enrollment StartDec 4, 2013
Primary CompletionDec 5, 2017
Study CompletionNov 6, 2018
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 12.7 years ago

Interventions

nab-paclitaxeldrug

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

nab-paclitaxeldrug

IV infusion