CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Irinotecan +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/NCT03323034
NCT03323034Phase 1Completed

A Phase 1 Study of Pevonedistat (MLN4924), a NEDD8 Activating Enzyme (NAE) Inhibitor, in Combination With Temozolomide and Irinotecan in Pediatric Patients With Recurrent or Refractory Solid Tumors

Children's Oncology Group·interventional·Posted Oct 26, 2017·Updated Oct 22, 2024

In Brief

A Phase 1 clinical trial evaluating Irinotecan, Pevonedistat, and 1 other intervention for Recurrent Lymphoma and 5 related conditions. Completed, enrolled 30 participants across 20 sites.

Detailed Summary

This phase I trial studies the side effects and best dose of pevonedistat when given together with irinotecan hydrochloride and temozolomide in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma that have come back after a period of improvement (recurrent) or that do not respond to treatment (refractory). Pevonedistat and irinotecan may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pevonedistat, irinotecan hydrochloride, and temozolomide may work better in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma compared to irinotecan and temozolomide alone.

Study Details

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 26, 2017
Enrollment StartJan 11, 2018
Primary CompletionSep 30, 2021
Study CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.7 years ago

Interventions

Irinotecandrug

Given IV

Pevonedistatdrug

Given IV

Temozolomidedrug

Given PO