Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors
Public ClinicalTrials.gov record NCT04337177. 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
Pilot Pharmacokinetic Study of VAL-413 (Orotecan®) in Patients With Recurrent Pediatric Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A pilot pharmacokinetic trial to determine the safety and efficacy of a flavored, orally administered irinotecan VAL-413 (Orotecan®) given with temozolomide for treatment of recurrent pediatric solid tumors including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma
Study identification
- NCT ID
- NCT04337177
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 20 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 1 Year 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
- Oct 25, 2021 (Actual)
- Primary completion
- Dec 2026 (Estimated)
- Completion
- Dec 2026 (Estimated)
- Last update posted
- Jul 30, 2026
2021 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| UCSF, Mission Bay - Benioff Children's Hospital | San Francisco | California | 94143 | — |
| Children's National Research Institute - Children's National Hospital | Washington D.C. | District of Columbia | 20010 | — |
| Children's Healthcare of Atlanta - Arthur M. Blank Hospital | Atlanta | Georgia | 30329 | — |
| Indiana University School of Medicine, Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Washington University - St. Louis | St Louis | Missouri | 63110 | — |
| University of North Carolina at Chapel Hill - North Carolina Cancer Hospital | Chapel Hill | North Carolina | 27514 | — |
| Atrium Health Levine Children's Hospital - Carolinas Medical Center | Charlotte | North Carolina | 28204 | — |
| Duke University Children's Hospital and Health Center | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Sarah Cannon Research Institute, Pediatric Hematology & Oncology | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04337177, 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 30, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04337177 live on ClinicalTrials.gov.