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NCT04337177 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumors and Neuroblastoma, sponsored by Valent Technologies.

Recruiting
Registry status
Phase 1
Development phase
20
Enrollment target
8
Study locations

NCT04337177 is a Phase 1 study of Solid Tumors and Neuroblastoma that is actively recruiting participants, run by Valent Technologies. The registered enrollment target is 20 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (93% lower). The trial reports 8 study locations across 6 states.

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The verdict

NCT04337177, a Phase 1 study of Solid Tumors and Neuroblastoma, is actively recruiting participants, sponsored by Valent Technologies.

RECRUITING
Registry status
Phase 1
Development phase
20 participants
Enrollment target
8
Study locations

Study Summary

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

Conditions Studied

Solid Tumors Neuroblastoma Rhabdomyosarcoma Medulloblastoma Ewing Sarcoma Hepatoblastoma

Interventions

  • DRUG Temozolomide
  • DRUG VAL-413

Study Locations (8)

North Carolina

  • University of North Carolina at Chapel Hill - North Carolina Cancer Hospital - Chapel Hill
  • Atrium Health Levine Children's Hospital - Carolinas Medical Center - Charlotte
  • Duke University Children's Hospital and Health Center - Durham

California

  • UCSF, Mission Bay - Benioff Children's Hospital - San Francisco

District of Columbia

  • Children's National Research Institute - Children's National Hospital - Washington D.C.

Indiana

  • Indiana University School of Medicine, Riley Hospital for Children - Indianapolis

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Tennessee

  • Sarah Cannon Research Institute, Pediatric Hematology & Oncology - Nashville

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-10-25
Est. Completion 2026-06
Phase Phase 1

Sponsor

Valent Technologies

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04337177

The ClinicalTrials.gov registry entry for NCT04337177 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (93% lower). The listed sponsor is Valent Technologies, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Temozolomide is the first listed.

NCT04337177 reports 8 study locations spanning 6 distinct geographic areas - top geographies include North Carolina, California, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT04337177 about?

NCT04337177 is a clinical study titled "Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors". 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 a...

What is the current status of trial NCT04337177?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-10-25. Estimated completion is 2026-06.

What conditions does trial NCT04337177 study?

This clinical trial studies the following conditions: Solid Tumors, Neuroblastoma, Rhabdomyosarcoma, Medulloblastoma, Ewing Sarcoma.

What interventions are being tested in trial NCT04337177?

The interventions under investigation include: Temozolomide (DRUG), VAL-413 (DRUG).

Who is sponsoring clinical trial NCT04337177?

This trial is sponsored by Valent Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04337177 being conducted?

This trial has 8 study locations across California, District of Columbia, Indiana, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.