At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
DFMO +1 moredrug
Likely dose
Not stated in 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.
A Phase I/II Trial of DFMO in Combination With Bortezomib in Patients With Relapsed or Refractory Neuroblastoma
In Brief
A Phase 2 clinical trial evaluating DFMO and Bortezomib for Neuroblastoma Recurrent. Completed, enrolled 16 participants across 6 sites.
Detailed Summary
The purpose of this research study is to evaluate an investigational drug (DFMO) in combination with bortezomib, for relapsed and refractory neuroblastoma. DFMO is an investigational drug because it has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the safety and tolerability of DFMO in combination with bortezomib as well as the tumors response to this study drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroblastoma Recurrent
CountriesUnited States
CollaboratorsBeat NB Cancer Foundation, Because of Ezra, K C Pharmaceuticals Inc.
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartJun 2014
Primary CompletionJan 2024
TodayJul 2026
First PostedMay 15, 2014
Enrollment StartJun 6, 2014
Primary CompletionJan 19, 2024
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 12.1 years ago
Interventions
DFMOdrug
Bortezomibdrug