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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: Recruiting Phase 1 study of Solid Tumors and Neuroblastoma, sponsored by Valent Technologies.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To establish the recommended Phase II dose of a flavored preparation of orally administered irinotecan VAL-413 (Orotecan®) when given in combination with temozolomide for 5 consecutive days
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What NCT04337177 shows while recruiting
NCT04337177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (93% lower).
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 lists 8 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04337177's enrollment target sits among peer trials
20 115th of 125 higher than 10 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
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A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
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Study of AUBE00 in Patients With Solid Tumors
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