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NCT01601535 · ClinicalTrials.gov registry record · Phase 1

Study of MLN8237 in Combination With Irinotecan and Temozolomide

A Phase 1 study of Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target
13
Study locations

NCT01601535 is a Phase 1 study of Neuroblastoma that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 54 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (77% lower). The trial reports 13 study locations across 11 states.

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The verdict

NCT01601535, a Phase 1 study of Neuroblastoma, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target
13
Study locations

Study 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 Studied

Neuroblastoma

Interventions

  • DRUG Temozolomide
  • DRUG Irinotecan
  • DRUG MLN8237

Study Locations (13)

California

  • Children's Hospital Los Angeles - Los Angeles
  • Lucile Packard Children's Hospital at Stanford University Medical Center - Palo Alto
  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco

Colorado

  • Children Hospital of Colorado - Aurora

Georgia

  • Children's Healthcare of Atlanta - Atlanta

Illinois

  • University of Chicago Comer Children's Hospital - Chicago

Massachusetts

  • Childrens Hospital Boston, Dana-Farber Cancer Institute. - Boston

Michigan

  • University of Michigan Comprehensive Cancer Center - Ann Arbor

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2012-05
Est. Completion 2018-07-25
Phase Phase 1

Sponsor

New Approaches to Neuroblastoma Therapy Consortium

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01601535

The ClinicalTrials.gov registry entry for NCT01601535 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (77% lower). The listed sponsor is New Approaches to Neuroblastoma Therapy Consortium, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.

NCT01601535 reports 13 study locations spanning 11 distinct geographic areas - top geographies include California, Colorado, Georgia.

Frequently Asked Questions

What is clinical trial NCT01601535 about?

NCT01601535 is a clinical study titled "Study of MLN8237 in Combination With Irinotecan and Temozolomide". 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 po...

What is the current status of trial NCT01601535?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2012-05. Estimated completion is 2018-07-25.

What conditions does trial NCT01601535 study?

This clinical trial studies the following conditions: Neuroblastoma.

What interventions are being tested in trial NCT01601535?

The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), MLN8237 (DRUG).

Who is sponsoring clinical trial NCT01601535?

This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01601535 being conducted?

This trial has 13 study locations across California, Colorado, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.