Study of MLN8237 in Combination With Irinotecan and Temozolomide
Public ClinicalTrials.gov record NCT01601535. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II Study of MLN8237 in Combination With Irinotecan and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01601535
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Months to 30 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2012 (Type not available)
- Primary completion
- Jul 25, 2018 (Actual)
- Completion
- Jul 25, 2018 (Actual)
- Last update posted
- Jul 31, 2019
2012 – 2018
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027-0700 | — |
| Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto | California | 94304 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| Children Hospital of Colorado | Aurora | Colorado | 80045 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| University of Chicago Comer Children's Hospital | Chicago | Illinois | 60637 | — |
| Childrens Hospital Boston, Dana-Farber Cancer Institute. | Boston | Massachusetts | 02115 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | — |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | — |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01601535, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2019 · Synced Oct 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01601535 live on ClinicalTrials.gov.