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NCT04337177 · ClinicalTrials.gov record · last posted 2026-07-30

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

Name: Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors — clinical trial record (NCT04337177)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusActive, Not Recruiting

PhasePhase 1

SponsorValent Technologies, LLC

Started2021-10-25

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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

Protocol amendment history 2 changes detected by DataLookout

2026-07-31

Primary completion pushed: 2026-06 → 2026-12

2026-07-31

Completion pushed: 2026-06 → 2026-12

Trial Details

NCT Number	NCT04337177
Lead Sponsor	Valent Technologies, LLC
Conditions	Solid Tumors, Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma, Hepatoblastoma, Medulloblastoma
Enrollment	20 participants
Start Date	2021-10-25
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-30