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Study of MLN8237 in Combination With Irinotecan and Temozolomide

NCT01601535 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-07-31

Study results available
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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.

Conditions

Interventions

DRUG

MLN8237

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

DRUG

Irinotecan

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

DRUG

Temozolomide

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

Sponsors & Collaborators

  • New Approaches to Neuroblastoma Therapy Consortium

    lead OTHER

Principal Investigators

  • Steven DuBois, MD · Dana-Farber Cancer Institute

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Months
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2018-07-25
Completion
2018-07-25

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01601535 on ClinicalTrials.gov