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Clinical trialNCT04337177Active, not recruitingPhase 1Interventional

Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors

SponsorValent Technologies, LLCEnrollment20Ewing SarcomaHepatoblastomaMedulloblastomaNeuroblastomaRhabdomyosarcomaSolid Tumors
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Phoenix Children'S Hospital

    Phoenix, Arizona, United States

  • Ucsf, Mission Bay - Benioff Children'S Hospital

    San Francisco, California, United States

  • Children'S National Research Institute - Children'S National Hospital

    Washington D.C., District of Columbia, United States

  • Children'S Healthcare of Atlanta - Arthur M. Blank Hospital

    Atlanta, Georgia, United States

  • Indiana University School of Medicine, Riley Hospital for Children

    Indianapolis, Indiana, United States

  • Washington University - St. Louis

    St Louis, Missouri, United States

  • University of North Carolina at Chapel Hill - North Carolina Cancer Hospital

    Chapel Hill, North Carolina, United States

  • Atrium Health Levine Children'S Hospital - Carolinas Medical Center

    Charlotte, North Carolina, United States

  • Duke University Children'S Hospital and Health Center

    Durham, North Carolina, United States

  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

  • Sarah Cannon Research Institute, Pediatric Hematology & Oncology

    Nashville, Tennessee, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
25 Oct 2021
Primary completion
31 Dec 2026
Completion
31 Dec 2026
Last update posted
30 Jul 2026
Registered enrollment
20
Registry id
NCT04337177

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.