CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
ABT-751 +1 moredrug
Likely dose
ABT-751 given orally (specific dose not stated)AI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed neuroblastoma that is refractory or relapsed
  • ✓Evidence of disease progression during prior treatment or biopsy-proven viable neuroblastoma if stable disease but refractory to prior treatment
  • ✓Measurable disease (≥20 mm by CT/MRI/x-ray OR ≥10 mm by spiral CT) or evaluable disease (123I MIBG-positive lesion without measurable CT/MRI disease)
  • ✓Karnofsky performance status 50-100% (>16 years) or Lansky PS 50-100% (≤16 years)
Key exclusion· 7
  • ✕No prior ABT-751
  • ✕No allergy to sulfa-containing medications
  • ✕No known HIV positivity
  • ✕No evidence of active graft-versus-host disease

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

Search/NCT00436852
NCT00436852Phase 2Completed
CompareCT.gov

A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children With Relapsed or Refractory Neuroblastoma

Children's Oncology Group·interventional·Posted Feb 19, 2007·Updated Jul 17, 2019

In Brief

A Phase 2 clinical trial evaluating ABT-751 and quality-of-life assessment for Disseminated Neuroblastoma and Recurrent Neuroblastoma. Completed, enrolled 92 participants across 12 sites in 2 countries.

Detailed Summary

This phase II trial is studying how well ABT-751 works in treating children with neuroblastoma that has relapsed or not responded to previous treatment. Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDisseminated Neuroblastoma, Recurrent Neuroblastoma
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 19, 2007
Enrollment StartJan 1, 2007
Primary CompletionSep 1, 2010
Study CompletionMar 30, 2015
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 19.4 years ago

Interventions

ABT-751drug

Given orally

quality-of-life assessmentprocedure

Ancillary studies