CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
MLN8237 +2 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.

Search/NCT01601535
NCT01601535Phase 2Completed
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Phase I/II Study of MLN8237 in Combination With Irinotecan and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

New Approaches to Neuroblastoma Therapy Consortium·interventional·Posted May 18, 2012·Updated Jul 31, 2019

In Brief

A Phase 2 clinical trial evaluating MLN8237, Irinotecan, and 1 other intervention for Neuroblastoma. Completed, enrolled 54 participants across 13 sites in 2 countries.

Detailed Summary

The goal of the first part of this clinical trial (Phase I portion) is to study the side effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to standard chemotherapy drugs, irinotecan and temozolomide. The goal of the second part of this clinical trial (Phase II portion) is to learn how many children and young adults show improvements in their neuroblastoma when treated with the combination of MLN8237, irinotecan, and temozolomide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroblastoma
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 25, 2018
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 14.1 years ago

Interventions

MLN8237drug

Every course will be 21 days. MLN8237 will be administered orally daily starting on day 1 through day 7.

Irinotecandrug

Irinotecan will be administered intravenously during each course on study day 1 through day 5.

Temozolomidedrug

Temozolomide will be administered orally during each course on study day 1 through day 5.